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Pharmaceuticals/Questions Answered by Expert Michael Anisfeld
| Subject | Date Asked |
| API Vs product Expiry Dating | 2/2/2012 |
| Q: Based on stability studies, we have fixed the shelf lives of our liquid vitamin preparations at 2 ... A: Except for powder products (where the API is mixed with other powders for use) there is no ... | |
| regarding expiry of pharmaceutical raw materials | 1/25/2012 |
| Q: If the expiry date of raw materials is 5 years and it is used in the last month or last week before ... A: For all the world except India, the expiration date is whatever you have proven by stability studies ... | |
| Repackaging | 1/16/2012 |
| Q: As a marketing fault claimed as customers orders priority, we received many orders to do repacking ... A: In this world of ever expanding counterfeit drugs on the market; there is great cause for concern by ... | |
| GMP/accumulation of lots | 12/27/2011 |
| Q: Is there any objection by regulatory authorities to accumulate different released production lots of ... A: As long as each batch has been individually tested and meets all specifications, prior to being ... | |
| Shelf life of drug products | 12/21/2011 |
| Q: I'm asking about determination of the shelf-life of the drug products which will not go through ... A: The stability of the finished product has little relationship to the stability of the original API ... | |
| Shelf life of drug products | 12/20/2011 |
| Q: I'm asking about determination of the shelf-life of the drug products which will not go through ... A: Eslam: Sorry but you will still have to perform a stability study for the final packaged (the ... | |
| Control Area and pass box | 12/17/2011 |
| Q: Respected Sir, What is exactly means static pass Box and Dynamic pass box. When in control area ... A: A static pass box is just a stainless steel box with two doors. A dynamic pass box is a stainless ... | |
| Presrerve capsule | 12/12/2011 |
| Q: Does aspirin (excedrin) come with one of those odd capsules for extending the shelf life or ... A: All capsules are made of gelatin and are designed to rapidly dissolve to release the drug inside. ... | |
| The difference between artificial tears and eye drops | 11/25/2011 |
| Q: Michael Anisfeld, Is there a real difference between artificial tears and eye drops? Because when I ... A: Yes there is a difference. Eye Drops are aqueous (water) based solution of active drug to cure a ... | |
| Re-test | 11/7/2011 |
| Q: How many times we can re-test API-s, or within period? Marc A: According to the Canadian GMPs, the only GMPs that reference this topic, you can retest the API ... | |
| stability | 10/27/2011 |
| Q: After completing the stability protocol for registration or postapproval change batches, is there ... A: Chuck: Yes, once you get into commercial manufacture, there is a requirement that one batch of ... | |
| GMP | 10/26/2011 |
| Q: Please explain alittle about the shoes that production personnel can wear in the original sites of ... A: For hygiene reasons, shoes need to totally enclose the foot (open toe shoes are not permitted). It ... | |
| MDI Shot Weight Test | 9/16/2011 |
| Q: I would like to ask whether there is any regulation or common practice as for the number of sprays ... A: If you are selling the product in the USA, then you need to follow USP, general chapter <601> which ... | |
| Stability Pull Date | 8/30/2011 |
| Q: Greetings, I will appreciate your help in clarifying whether the stability test intervals (e.g., ... A: Stability/Expiration dating is based on the date of initial manufacture. If you are making ... | |
| Room Mapping | 8/26/2011 |
| Q: Want to know about temperature mapping in room. We have a process cubicle in sterile area where ... A: You need to map the room for temperature and humidity - a minimum of 10 points simultaneously mapped ... | |
| Autoclave validation | 8/10/2011 |
| Q: We are doing Autoclave revalidation once in a year. We have total 20 loading patterns. Is it ... A: Assuming: a. that we are talking about a singe autoclave running the exact same cycle for all 20 ... | |
| ketrolac injection | 8/8/2011 |
| Q: we are preparing ketrolac tromethamine injection of 30mg/ml{2ml fill} strenth vials. after terminal ... A: Madhusudan: Your first step needs to be a microscopic and chemical analysis to determine what the ... | |
| Cleaning Validation related | 8/8/2011 |
| Q: I have two queries regarding CV- 1. We have based our worst case selection of product based on ... A: MY RESPONSES ARE IN CAPITALS BELOW: Dear Sir, I have two queries regarding CV- 1. We have based our ... | |
| stability alarm system | 8/3/2011 |
| Q: Is it required by agencies (FDA, ICH, etc) to have an alarm system with the stability chambers, cold ... A: Yoko: Terrific question. A straight reading of all the world's GMP regulations requires that the ... | |
| Paxil | 8/1/2011 |
| Q: I am taking Paxil but have a phobia of taking medicine. I am afraid something will be wrong with my ... A: Lara: I am taking Paxil but have a phobia of taking medicine. I am afraid something will be wrong ... | |
| torque tester | 7/29/2011 |
| Q: We are filling a food (which might be registered later as a drug) liquid product in screw-top ... A: You can, but unless it is in the dye bath, how will you know whether you have a leak? Radwan: This ... | |
| torque tester | 7/29/2011 |
| Q: We are filling a food (which might be registered later as a drug) liquid product in screw-top ... A: Radwan: Foods are subject to bacterial contamination, which is why you are placing them in a bottle ... | |
| expiration dating | 7/18/2011 |
| Q: This is a query on expiration dating. The expiration dating was provided same month, 2 years later ... A: Product Stability is packaging configuration specific and manufacturing location specific; you ... | |
| issue of Manometer and window in QC laboratory | 7/5/2011 |
| Q: Michael! I've two1. How should we organize a matter of setting manometer? Is it governed by the ... A: but I am very confused in trying to understand what is happening and what you are trying to do. I ... | |
| Cleaning validation | 7/3/2011 |
| Q: Michael Anisfeld, 1.How will I classify the products into therapeutic groups during the cleaning ... A: Cleaning validation has nothing to do with therapeutic groups. it has everything to do with ... | |
| Sampling process of bulk and finished product | 6/24/2011 |
| Q: Michael! I want to ask you regarding sampling process of bulk and finished product. Our factory has ... A: Cleaning validation for sampling tools is a very big problem, as well as tracking and recording the ... | |
| Cleaning Validation | 6/14/2011 |
| Q: Is there any requirement to carry out Cleaning validation in single product campaign production ie, ... A: Yes. While you do not need to clean the equipment between individual batches of a campaign (other ... | |
| 5-HTP potency | 6/7/2011 |
| Q: I purchased 6 bottles of Hydroxytryptophan in capsule form--all natural made from "Griffonia ... A: An interesting question. Thanks. According to the scientific literature, the storage conditions for ... | |
| skip testing | 5/18/2011 |
| Q: regarding your answer for reduce testing of raw materials ,just i want to ask the type of tests can ... A: Q1.shall i have to make validation for pharmacopoeia. test method for raw materials OR can i use it ... | |
| Biological Mdecines | 5/3/2011 |
| Q: I have a question about manufacturing biological- Biosimilar medicines such as Gama interferon, ... A: Afshin: Biological medicines such as gamma-interferon cannot be manufactured in the same facilities ... | |
| Pharmaceutical | 4/28/2011 |
| Q: It is the first time I am asking the question with you. It will be the great honor for me if you ... A: I wish I could give you an exact answer (e.g. 45 days from now), but I cannot. Several thoughts: a. ... | |
| ketorolac tromethamine injectable solution | 4/28/2011 |
| Q: in our process of ketorolac tromethamine injectable solution production, after filling the solution ... A: Start off my microscopic examination of the particles to identify what they are. 8 times out of 10 ... | |
| Reduced Testing | 4/25/2011 |
| Q: Following on from a previous question about reduced testing: In the case where a generic ... A: Now you are really stretching the issue at hand. Everything depends on what is specifically ... | |
| BALANCES – OPERATION AND USE | 4/15/2011 |
| Q: We have a glucose-based 20-mL liquid product with a spray bottle as the package. We have got ... A: Radwan, before I start, please can you make questions on different topics as new questions rather ... | |
| Reduced Test | 4/13/2011 |
| Q: I work with physical chemical analysis of raw materials and would like to know where I find ... A: Jose: Typically, once you qualify the supplier by performing an analysis of three separate lots of ... | |
| relative humidity | 3/31/2011 |
| Q: What is the minimum acceptance limit for relative humidity inside a medical warehouse. Do we have to ... A: Your temperature and humidity specificatiosn need to be based on the needs fo the raw ... | |
| sodium chloride | 3/31/2011 |
| Q: sodium chloride is used in different dosage forms. if i want to use it in sterile eye ointment ... A: It makes no difference whether you purchase the NaCl sterile or not. To make your eye drops you ... | |
| Qualification versus calibration | 3/25/2011 |
| Q: I need to know about qualification requirement for various instruments that are hand held like 1. ... A: Please realize that: a. instruments are calibrated; b. equipment is qualified; c. processes are ... | |
| Extending API shelf-life | 3/9/2011 |
| Q: If a finished product manufacturer has created it's own stability program for the API used in its ... A: If the finished product user of the API has generated a stability program for the API - as an API ... | |
| flavors | 3/9/2011 |
| Q: are their grades for flavors? which type i must use in medicines? A: Flavors must, at a minimum, be certified as food grade. They must also be permitted in the country ... | |
| leaching / extractable studies | 3/7/2011 |
| Q: We have MDI device and the dosage form is liquid with aerosole. Where can I find the regulations for ... A: SEE RESPONSES BELOW IN CAPITALS: The suppliers of the valves and the cans do the extractable ... | |
| leaching / extractable studies | 3/3/2011 |
| Q: We have MDI device and the dosage form is liquid with aerosole. Where can I find the regulations for ... A: SEE RESPONSES BELOW IN CAPITALS: We have MDI device and the dosage form is liquid with aerosole. ... | |
| freeze/thaw cycle test | 3/1/2011 |
| Q: We have a glucose-based 20-mL liquid product with a spray bottle as the package. We have got ... A: Yes of course. You do the freeze-thaw cycles (freeze for 24rs, then thaw) on three separate batches ... | |
| EXCIPIENT RESERVE SAMPLES | 2/26/2011 |
| Q: What are the requirements for excipient reserve/retain/file samples for clinical manufacturing used ... A: Your answer will depend on which countries you are manufacturing the material in and which country ... | |
| raw material/api/component expiry | 2/23/2011 |
| Q: Is there a regulatory document that clarifies whether or not it is okay to use an API, excipient, ... A: Jill: Unfortunately none that I am aware of. GMPs state that you cannot use a raw material beyond ... | |
| Stability | 2/22/2011 |
| Q: Sir thank you in advance, my question are: Q1. How long stability study perfom to extend exixting ... A: Q1. How long stability study perform to extend existing expiry date in case of solid, liquid, ... | |
| Retest of API | 2/18/2011 |
| Q: I understand from previous answers that the use of an API in Canada can be extended by a successful ... A: JENNIFER - SEE ANSWERS BELOW: I understand from previous answers that the use of an API in Canada ... | |
| Stability | 2/18/2011 |
| Q: Hope you are well.For better management and evaluation sir please provide me some information such ... A: 1) How long after expiry tablet, capsule, dry syrup & suspension,syrup & suspension, cream & ... | |
| Stability | 2/18/2011 |
| Q: Hope you are well.For better management and evaluation sir please provide me some information such ... A: a) When & how many batches will be monitored for stability? FIRST THREE MADE OF EACH STRENGTH, AND ... | |
| Reduced Sampling | 2/17/2011 |
| Q: I am planning to implement a program of pre-sampled material from our suppliers. This sample is ... A: Myrna: In principle, why not? But be careful, FDA issued a Warning Letter to Kyowa Hakko in ... | |
| Extension of shelf life | 2/3/2011 |
| Q: "If the manufacturer's shelf life is known, and the material is retested and meets all testing ... A: Brook: I have never come across the statement that you reference - so I cannot comment, other than ... | |
| Pilot Plant in a cosmetic plant | 2/3/2011 |
| Q: Mike! Do you believe that a Pilot Plant that manufactures cosmetic and OTC products should follow ... A: Lisa: If the pilot plant is making product for human use (either clinical or commercial use) then ... | |
| Medical device Accessories | 1/26/2011 |
| Q: may be you can help me with question. Do Medical Devices require preservative assays like “regular” ... A: Maryna: Your laser is a device. Your post-laser skin care is a drug (or maybe, it could be a ... | |
| cleaning validation | 1/24/2011 |
| Q: Mr. Anisfeld! We have conducted cleaning validations on a mixing tank that is used for OTC ... A: Lisa: What is the question? If you failed your cleaning validation, then your only choices are: a. ... | |
| FOOD and DRUG COLORS | 1/24/2011 |
| Q: what is the differences between food and drug colors? can i use food color in drugs? A: In brief - in some countries there is a difference, in other countries there is no difference. You ... | |
| Secondary packaging of oncology products and GMP manufacturing of oral gels | 1/21/2011 |
| Q: I have 2 questions: The first: Is it OK to conduct secondary packaging of oncology products in a ... A: Question 1: Theoretically yes if the primary package is properly sealed, then there is no risk of ... | |
| 1% solution mouthwash | 1/8/2011 |
| Q: I want to make up a 1% solution of tacrolimus as a 1% oral suspension mouthwash. Using Prograf 1mg ... A: Andrew: As you need specialized equipment, such as a homogenizer, to make this suspension in a way ... | |
| lactulose concentrate | 1/3/2011 |
| Q: iam confused about the use of lactulose concentrate directly to human, the usp states that the ... A: The BP/USP are just books of quality standards; that stated that if the terms BP/USP are used the ... | |
| press through strips | 1/2/2011 |
| Q: what kind of protection does press through strips blister provide? and for what drugs they are used? ... A: the type of blister pack that you use is dictated by marketing considerations, not by stability ... | |
| stability climatic zones | 12/27/2010 |
| Q: with regard to the climatic change , what climatic zone should we follow at Palestinian National ... A: Where you are located is zone II for stability studies according to ICH guidelines. And, no, you ... | |
| api retesting date | 11/29/2010 |
| Q: .....until what date i can use it?should i have a stability data for API or not. A: According to the Canadian GMPs, yes, if on each retest the API passes all specification tests. No ... | |
| HPMC 2900 CP 15 | 11/25/2010 |
| Q: THIS IS ANOTHER QUESTION LEASE CAN I USE HPMC 2900 CV 15 FOR EXTENDED RELEASE THANKS ALOT A: Maybe, maybe not. It all depends on the results of: a. your bioavailability/bioequivalence testing ... | |
| Placebo Expiry | 11/24/2010 |
| Q: sir, Have you come across the expiry of Pharmaceutical placebo's, since normally Oral products have ... A: Placebos are only used in clinical trials, and then typically the expiration date of the clinical ... | |
| Validation | 11/16/2010 |
| Q: Mr Anisfeld! I met you at the training you conducted at AC a few yrs ago. I have a question on ... A: At least one of the batches you are discussing for stability needs to be at a minimum of 10% of the ... | |
| Rawmaterial input quantities | 11/10/2010 |
| Q: Its very knowledge gaining aspect for me when i saw your responses. I would like to know from you ... A: for citations as to the need to weigh exactly the amount stated - see the US, EU and WHO GMPs. Your ... | |
| expiration date of compounded Prednisolone | 11/7/2010 |
| Q: A compounding pharmacy I have used sent me compounded Prednisolone (water based) with a 6 month ... A: For oil based, I am not sure that refrigeration can assist; in fact refrigeration might cause the ... | |
| expiration date of compounded Prednisolone | 11/7/2010 |
| Q: A compounding pharmacy I have used sent me compounded Prednisolone (water based) with a 6 month ... A: The expiration date of your formulation depends on the specific formulation that the compounding ... | |
| Rawmaterial input quantities | 11/3/2010 |
| Q: Its very knowledge gaining aspect for me when i saw your responses. I would like to know from you ... A: When weighing raw materials, there is no (zero) variation allowed. The amount stated in the batch ... | |
| Number of Production Runs required | 10/21/2010 |
| Q: Good morning: My question concerns long term ambient stability testing procedures. I understand the ... A: FDA requires: a. from the first three commercial batches manufactured - 3 accelerated for 6 months ... | |
| Mean Kinetic Temperature | 10/15/2010 |
| Q: I have two questions- 1. Is mean kinetic temperature applies to cold & freeze conditions?If no why? ... A: Does MKT apply to cold/freeze conditions? Yes, see USP General Notices and the USP Chapter on ... | |
| Retain Requirements | 10/7/2010 |
| Q: I was wondering what retains I would need to keep for the following scenario. We will make product ... A: I am confused by your question. First you state "Batches will be filled in to lots and a packaged ... | |
| GMP gowning procedure | 10/5/2010 |
| Q: 1. Can you explain the proper procedure to enter a GMP grade B room? If we are completely covered up ... A: Gowns for Grade "C" do not need to be sterilized. Gowns for Grades A+B must be sterilized and single ... | |
| Leak Testing Parameters for Drug Products | 10/3/2010 |
| Q: Is there any specific requirements of settings for vacuum leak test such as pressure, time for ... A: I recommend that you follow ASTM or ISO methods - thus giving you no problems or questions from ... | |
| Veterinary Use Medicine | 10/2/2010 |
| Q: Anisfelf, Would you kindly explain me if it is allowed to manufacture a human use medicine in a ... A: Bravo: Both US and EU regulations permit the manufacture of human and veterinary drugs in the same ... | |
| Extending Shelf life of Expired Material | 9/30/2010 |
| Q: If we have a material(API) which is expired very recently. During communication with supplier, he is ... A: You can extend the shelf life and usage of the API on two conditions: a. Your API supplier notifies ... | |
| Relabeler | 9/29/2010 |
| Q: Can one company be registered to the FDA as drug repacker and also a drug relabeler. ANSWER: Yes - ... A: Both relabelers and repackagers need to meet the GMP requirements stated in the ICH-Q7 guidelines ... | |
| Stability retest extrapolation after 36 month | 9/27/2010 |
| Q: Sir, I had read somewhere that for an API we cannot extrapolate the retest period after 36 month ... A: The only GMP guide in the world that discusses this issue is the Canadian GMP guide from 2009. ... | |
| Using of expired raw material | 9/25/2010 |
| Q: In our products we use lot fine chemicals like buffers, preservatives, stabilizers, and enzymes; I ... A: The only GMP guide in the world that discusses this issue is the Canadian GMP guide from 2009. They ... | |
| NIRA technology | 9/15/2010 |
| Q: Anisfel I've been interested about a technology you mentioned in one of your answers, I mean NIRA ... A: NIRA - Near Infra-Red Analysis. NIRA is a technology that has been around for about 20 years, and ... | |
| Reduced Testing for Raw Materials | 9/9/2010 |
| Q: I have a question regarding reduced testing on lots of received material. Our company plans to ... A: Sorry, but the ID/potency testing needs to be performed on incoming drums of material. If you have a ... | |
| Pharma(Formulations) | 9/8/2010 |
| Q: What kind of air filteration is required in the secondary packaging and warehousing area as per ... A: According to the WHO GMP HVAC guidelines: warehouses and secondary packaging areas need no air ... | |
| Freeze / Thaw Stability | 8/27/2010 |
| Q: in a previous answer you state that a product is typically exposed to three freeze-thaw cycles ... A: Sorry but I do not have the OGD guide anymore, and the 1995 Canadian GMP guide is not on the web, ... | |
| Freeze / Thaw Stability | 8/26/2010 |
| Q: in a previous answer you state that a product is typically exposed to three freeze-thaw cycles ... A: Oliver: Although the ICH guideline [ICH-Q1A(R2)]does not state a specific number of cycles, there ... | |
| Stability study - API | 8/24/2010 |
| Q: The retest period of a API is reached( initially established to 3 years)Now we wish to use this ... A: I'm still very confused: a. if you only have to-date 24-months stability data, under what ... | |
| Retest & Expiry Date | 8/20/2010 |
| Q: First of all I’d like to thank you for your assignment. I want to inquire about a matter which is ... A: Although they have different definitions, but most API manufacturers mix-up the terms "expiration" ... | |
| temperature related-URGENT | 8/19/2010 |
| Q: For a tablet with blister packing if no specified storage temperature is prescribed and the mkt is ... A: Even with global warming an MKT of 27oC is very high for the UK - is this a product for tropical ... | |
| Retest & Expiry Date | 8/17/2010 |
| Q: First of all I’d like to thank you for your assignment. I want to inquire about a matter which is ... A: When you retest teh API it is "released" for the next 30 days and can be in the "released" area; ... | |
| Sampling of Active or Non Active Pharmacutical Raw Material | 8/13/2010 |
| Q: I wonder if you can explain me more about the word "Representative" you mentioned on your answer to ... A: Bravo: "Representative" means exactly that. Suppose you have a drum of an equal mixture of a ... | |
| Dispensing of Liquid Material | 8/8/2010 |
| Q: Is need to dispensing and QC sampling the liquid material and solvent under Reverse Laminar Air ... A: To prevent contamination of the material being weighed, it is required that the weighing be ... | |
| pharmaceutical raw materials | 8/3/2010 |
| Q: Since the regulations are vague is there some type of industry standard to follow for raw material ... A: For chemicals, to meet EU GMPs you need to sample sufficient chemical from each drum to perform all ... | |
| MKT | 7/26/2010 |
| Q: My question is about mean kinetic temperature (MKT) could you kindly tell me regarding the cold and ... A: If you would read the USP General Notices, you will find that it states: ... | |
| GMP | 7/25/2010 |
| Q: What are the WHO recommended temperatures and humidity for a pharmaceutical manufacturing plant? A: My immediate response was that the pharmaceutical manufacturing plant temperature should be between ... | |
| gamma irradiation | 7/23/2010 |
| Q: i would like to know if we can use gamma ray for sterilization of eye drop solutions . thank you in ... A: In theory, yes of course you can. But ............. some problems you might encounter are: a. gamma ... | |
| Producing of Hormones | 7/18/2010 |
| Q: Many thanks for your previous answer about the medicinal products which to be produced in dedicated ... A: Either - as long as you can prove that there is absolutely, positively, no cross-contamination ... | |
| Which specific products / product types have to require mandatory dedicated facilities? | 7/13/2010 |
| Q: Can you kindly explain for me which category or (ies) of medicine "Must be" produced in dedicated ... A: Products that are "sensitizing" and can cause anaphylactic shock (resulting in death within about 45 ... | |
| Drug Re-labeller | 7/12/2010 |
| Q: Can a FDA register drug re-packer also register as a drug re-labeler, what is the major difference ... A: A drug repackager essentially repackages bulk drug (say 100Kg quantity) into smaller sizes (say 5 ... | |
| Raw material storage requirement | 7/6/2010 |
| Q: I would like to know what is meant by Room Temperature with respect to raw material storage. we ... A: The USP defines room temperature as: Room Temperature — The temperature prevailing in a working ... | |
| freeze thaw | 6/29/2010 |
| Q: please let me know that how Freeze thaw cycle design for parenteral protein product.is it necessary ... A: Usually people freeze the material and keep it frozen for 24 hours. Then they thaw the material, ... | |
| freeze thaw | 6/29/2010 |
| Q: please let me know that how Freeze thaw cycle design for parenteral protein product.is it necessary ... A: All guidelines that I am aware of state that freeze/thaw cycles need to be performed where ... | |
| Cold Rooms | 6/28/2010 |
| Q: Where do I find specifications for colsd rrooms to store pharmacuticals. IE: ... A: The United States Pharmacopoeia (USP) defines "cold" as in "cold room" ....... as storage at a ... | |
| freeze thaw | 6/25/2010 |
| Q: please let me know that how Freeze thaw cycle design for parenteral protein product.is it necessary ... A: Freeze thaw cycles usually cycle between "freeze" (defined by USP as a temperature between -25oC and ... | |
| Medication Temperature storage | 6/3/2010 |
| Q: If shelf medication to stored at 75 degree temps or higher, how long can they be exposed to this ... A: 75 degrees (I assume you mean Fahrenheit) is equivalent to about 25oC which is room temperature ... | |
| regarding Dynamic pass box validation | 5/22/2010 |
| Q: Daer Sir, In a new facility where we are going to manufacture vaccines for HVAC validation, is it ... A: I am confused by youra. you do not make vaccines for HVAC validation - you qualify HVAC to make ... | |
| meida fill | 5/3/2010 |
| Q: Media fill: Is it necessary to perform the visual inspection of vilas/ampoules before the ... A: Your question was clear, and I thought so was my answer. Let me repeat: 1. fill and seal your vials ... | |
| cleaning validation | 4/27/2010 |
| Q: I have two questions regarding cleaning validation:1)Is it correct to select a specific criterion ... A: 1. Yes you need to define what is "clean". There are three criteria that you need to consider, and ... | |
| Patent infringement contract manufacturing | 4/16/2010 |
| Q: Would you be able to judge if a pharmaceutical contract manufacturer is allowed to supply a ... A: Now that you have provided more details, the issue devolves to theare you discussing a product ... | |
| Patent infringement contract manufacturing | 4/16/2010 |
| Q: Would you be able to judge if a pharmaceutical contract manufacturer is allowed to supply a ... A: As long as the product is not sold in interstate commerce, then there is no patent infringement. So ... | |
| environmental classes | 3/31/2010 |
| Q: What latest reference should i refer to. M. Etman A: Where the tablets are exposed to the environment (prior to being closed in the blister/bottle), the ... | |
| Production area | 3/26/2010 |
| Q: Is it acceptable to manufacture Cephalosporin and Penicillin in the same building dedicated working ... A: You can work in a "campaign" manner as long as you can absolutely prove that your cleaning routines ... | |
| Retest of Raw materials - APIs/Excipients | 3/20/2010 |
| Q: I would like to know what is the number of times that i can retest a raw material ( be it API or ... A: Sadanand: India is unique because Schedule 'M' seems to state (as I am repeatedly advised by Indian ... | |
| Differential pressure in manufacturing areas | 2/25/2010 |
| Q: e. the pressure inside the cubicles is greater than that of the corridors and you have a strict ... A: GMPs do not require differential pressures - GMPs require that the potential for cross-contamination ... | |
| Preservative assay in stability studies | 2/25/2010 |
| Q: i would like ask you about the assay of preservative during stability study. Some times the ... A: Subject: Preservative assay in stability studiesDear Anisfeld, i would like ask you about the assay ... | |
| pharmaceutical bulk ingredient packaging | 2/24/2010 |
| Q: Do you think it is appropriate to package hygroscopic bulk ingredients in fiber drums regardless of ... A: As I stated - the primary packaging is what is the most important factor in protection against ... | |
| pharmaceutical bulk ingredient packaging | 2/22/2010 |
| Q: Do you think it is appropriate to package hygroscopic bulk ingredients in fiber drums regardless of ... A: Carl: A fibre drum, or any external drum, only provides structural integrity to the package during ... | |
| Shelf life granted to generic drugs | 2/17/2010 |
| Q: There is a strong mindset in generic pharma industry that FDA doesnt grant expiry period of more ... A: Paritosh: I do not know where you are getting your information from, but it is incorrect. There are ... | |
| working standard vial expiry | 2/15/2010 |
| Q: What is expiry date of working standard vial after opening? A: for the unopened standard, it is whatever the expiration date states. For the opened standard, you ... | |
| Bioequivalence of liquid filled SGC | 2/9/2010 |
| Q: My question is about the necessity of doing bioequivalnce studies to liquid filled soft gelatin ... A: Bioequivalence studies are to demonstrate that your formulation has equivalent dose release ... | |
| OOT results | 2/8/2010 |
| Q: My question is concerned with the out of trend results in the stability studies. Results obtained ... A: OK - Now I see what you mean. And, yes, a result that is 5% different from previous results would ... | |
| Stability | 2/7/2010 |
| Q: how long would it be acceptable for a stability chamber to deviate from its setting with regards to ... A: USP General Chapter <1150> on "Stability" refers to "permissible excursions" from specification, and ... | |
| Stability | 2/7/2010 |
| Q: It is my pleasure to talk to you again. My question is concerned with stability studies of some ... A: There is no regulatory requirement, in any jurisdiction worldwide, to perform accelerated stability ... | |
| Process validation - active substance | 2/5/2010 |
| Q: Michael Anisfeld I would like to ask about a process validation. In a 3-lot process validation, ... A: It is precisely because you used the scaled down reaction in your 3rd validation batch, that the 3 ... | |
| Process validation - active substance | 2/5/2010 |
| Q: Michael Anisfeld I would like to ask about a process validation. In a 3-lot process validation, ... A: If this human error occurred in a preliminary reaction step, then I suggest that with a proper ... | |
| packaging vitamins | 1/27/2010 |
| Q: i have a formula to a multivitamin i would like to manufacturer package and sell, where can i find a ... A: There are any number of companies that would be delighted to take your money and manufacture the ... | |
| shelf life of medicines | 1/26/2010 |
| Q: I would like to know what the shelf life of Excedrin Migraine caplets in an unopened , sealed bottle ... A: If the bottles are opened, and have been stored continuously at the manufacturers recommended ... | |
| Raw materials expiry | 1/21/2010 |
| Q: I am currently working in an In vitro diagnostic company and I am doing a study about expiry date of ... A: If the question was posed by an auditor from a client company, ask them what they do (and to share ... | |
| Raw materials expiry | 1/20/2010 |
| Q: I am currently working in an In vitro diagnostic company and I am doing a study about expiry date of ... A: Raphael: You are asking a terrific question; one that, regretfully, I doubt that you will find ... | |
| Batch release | 1/20/2010 |
| Q: Can we release API for use in manufacturing of batch without full analysis(Outside testing, provided ... A: The answer is "it depends". If you are the API maker selling the API to a separate company, then ... | |
| Process validation | 1/20/2010 |
| Q: As for process validation, consecutive batch should be there,so my question is for XYZ product if ... A: Validation proves that the process can consistently make product meetign specification. If you only ... | |
| primary pharmaceutical packaging | 1/13/2010 |
| Q: we produce primary packaging glass containers for pharmaceutical industry. What do terms "expiry ... A: Unless your glass decomposes and has a date after which you cannot guarantee that the glass meets ... | |
| Pouch packaging of pharmaceuticals | 12/31/2009 |
| Q: We need to package a pharmaceutical-grade amino acid for human trials. The daily doses would range ... A: Assuming that the packaging provides product stability for the entire duration of the trial, and the ... | |
| manufacture of different products in one area | 12/22/2009 |
| Q: Does manufacturing of intravenous antibiotics (e.g. erythromycin and vancomycin)in an area where ... A: Joy: The answer is - "it depends". It depends on whether the antibiotics are sensitizing (e.g. ... | |
| Raw material testing | 11/4/2009 |
| Q: Reading guidelines about raw material testing for the pharmaceutical industry, I often find the word ... A: The amount of testing is based on the supplier history and your confidence in the Supplier's ... | |
| Required pressure on manometers | 10/30/2009 |
| Q: Respected sir please send me a map of ideal ware house for pharmaceutical industry , where we could ... A: Why do you need to read pressure in warehouses? The key issue is temperature. If you are trying to ... | |
| Retain Samples | 10/28/2009 |
| Q: I am trying to determine if there are any rules FDA/Foreign that would require a retain sample for ... A: Interesting questions. 21CFR211.170 on Reserve Samples states: "(b) An appropriately identified ... | |
| Off-label prescriptions | 10/27/2009 |
| Q: I know that the FDA cannot regulate a physician's prescribing FDA approved drugs for off-label uses, ... A: Claire: You appear to be correct (but as I am not a lawyer, I cannot state that you legally "are ... | |
| MAP OF DEDICATED WARE HOUSE (RAW , PACKING AND F/G ) | 10/26/2009 |
| Q: Respected sir please send me a map of ideal ware house for pharmaceutical industry , where we could ... A: There is no such thing as the "ideal" warehouse, as it depends on your product needs (degree of ... | |
| Raw Material Sampling | 10/15/2009 |
| Q: Is there any guideline which cites the quantity for Raw material sampling? Or from where this root ... A: You are asking two different questions. For chemicals you need to sample sufficient material to ... | |
| API | 10/13/2009 |
| Q: my question is how we give expiry date to a finished dose form product, and if we have an API lot ... A: With the exception of products sold in India (they have a unique interpretation of API stability and ... | |
| Temperature and humidity requirement for multi vitamins and pharmaceutical excepients | 10/5/2009 |
| Q: Respected sir i am employee of a pharmaceutical company as manager stores. would you like to brief ... A: The temperature/humidty requirements required in your warehouse will relate to what you are storing. ... | |
| Ideal and dedicated map of raw , packing ang finished goods stores in pharmaceutical industry | 9/29/2009 |
| Q: Respected sir i am employee of a pharmaceutical company as manager stores. would you like to brief ... A: You need separate areas for: a. goods receipt (unloading dock) b. raw material sampling area (a ... | |
| GMP Specifications for Relative humidity and temperature. | 9/28/2009 |
| Q: Please what are the various classes of areas in the pharmaceutical manufacturing plant with ... A: According to the USP (Genral Notices), the following definitions apply: Freezer— A place in which ... | |
| Stability testing pulling times | 9/28/2009 |
| Q: I was wandering whether you could help with my query relating to stability testing of ... A: The answers you seek were covered in an FDA OGD Guideline, withdrawn a few years ago. Samples with ... | |
| Pharmaceuticals | 7/2/2009 |
| Q: Have a nice Day My question is: Can we give Retesting date to Raw Material beyond its expiry date ... A: The only GMP providing guidance on this, worldwide, is the Canadian GMPs. They state that if the ... | |
| Expiry date vs date of manufacture vs shelf life | 6/24/2009 |
| Q: My question is regarding expiry dating which is usually expressed as month and year. If a pharma ... A: Kevin: The date of manufacture is the date that the ingredients first get to meet each other, say ... | |
| Reprocess of nearing expiry drug substance | 6/22/2009 |
| Q: One of my friends wants to reprocess the nearing expiry drug substance. If he does, then What would ... A: you can do this on two conditions: a. you have stability data (at a minimum 6 months accelerated ... | |
| Microbiological testing of pharmaceutical stability samples | 11/5/2008 |
| Q: I saw your answer regarding the frequency of testing for stability and wonder if microbiological ... A: If the study is to establish an expiration date for a new product, then microbial testing is ... | |
| zaleplon | 10/30/2008 |
| Q: Can you tell me how to obtain zaleplon in Canada? It used to be available as Starnoc, but appears ... A: Humble and profuse apologies. I was mixing the drug in my mind with Zolpidem (sold here as Ambien) ... | |
| zaleplon | 10/29/2008 |
| Q: Can you tell me how to obtain zaleplon in Canada? It used to be available as Starnoc, but appears ... A: Zaleplon is sold in the USA as Ambien. It is banned in Canada and is not available there. I ... | |
| Vertical form fill seal machines | 10/7/2008 |
| Q: We are trying to place powdered nutritional supplements into a 3 or 4 sided pouch. It is a fine ... A: Vicki: Many moons ago I used to run a powder fill line for pharmaceutical products, and will share ... | |
| microbiological testing in pharmaceuticals | 9/23/2008 |
| Q: Can I get rid off Autoclave if I use 'ready to use media / plates/ tubes' in the microbiological ... A: JK: I wish you could, but have you thought about how you will decontaminate the growth plates after ... | |
| Brand Name Synthroid vs. Generic | 9/22/2008 |
| Q: My doctor, who I respect, and his entire endocrinology practice at a major Baltimore hospital, ... A: As the FDA has approved generic Synthroid as bio-equivalent to the original brand, you will have a ... | |
| Freeze Thaw Study | 9/20/2008 |
| Q: I would like to know how is freeze/thaw study carried out for Liquid oral products with references, ... A: Take your liquid product, cool at -5oC to freeze, and hold frozen for 24 hours; then thaw at room ... | |
| Drug Safety | 9/18/2008 |
| Q: I get extremely intense anxiety when flying on airplanes. A few years ago, I went to a doctor and ... A: All drugs degrade from the date of manufacture, losing effectiveness and potentially building up ... | |
| Clonidine and Atenolol manufacturing | 9/12/2008 |
| Q: I have a question about these two medications. My mother takes both for her high blood pressure and ... A: Sheryl: Welcome to the wonderful world of generic drugs. When the product patent expires, ... | |
| Quality Index in pharmaceuticals | 8/21/2008 |
| Q: What is quality index.pls give the importance of it.Is their any reference for this. A: There is no uniform definition, and many people use the term in may different ways. As examples, ... | |
| writing the dossier when only CEP is available | 8/12/2008 |
| Q: I have a problem, I need to write a registration documentation in EU format (not CTD) - the IIF ... A: I commiserate with you, having been in the same situation a few years back. The EU reviewers demand ... | |
| stability/balance calibration | 7/26/2008 |
| Q: stability what to do if our product shows significant change in accelerated condition calibration ... A: stability - by "change" in stability - do you mean that the product does not meet its specification ... | |
| generic drugs -- not quite the same | 7/23/2008 |
| Q: Are you aware, that by law, generic drugs do not have to bioidentical? Meaning they can contain ... A: Lori: Sorry, but I completely disagree with you. According to the Good Manufacturing Practices ... | |
| Hi | 7/10/2008 |
| Q: Can you suggest me what is most acceptable date format or most suited date format in Industry ... A: Most of the industry uses the ISO Standard date format. This is YYYY-MMM-DD. So today's date July ... | |
| Hi | 7/10/2008 |
| Q: Not for any question, But I got your profile so contacted We met at Artemis Biotech, Hyderabad; ... A: Soni: Yes indeed I do remember you. What are you doing now and how is it going? Incidentally, what ... | |
| Sampling conditions for non sterile raw materials | 7/10/2008 |
| Q: I wanted to know if there are any environmental conditions that should be adhered to for non ... A: Sampling for chemical testing is routinely performed in a Class 100,000 (ISO Class 8) environment. ... | |
| Stability samples transfer | 7/9/2008 |
| Q: I would like to know is it ok to transfer a stability study from one country to another during the ... A: In principle I do not see any problem with this except one. The transportation issues are not of ... | |
| FBD bag | 6/6/2008 |
| Q: I would like to know about the "material Of Construction" (MOC) of FBD bag. Thank you very much, ... A: You must, I repeat MUST, personally audit the bag fabricator - and take someone with you who knows ... | |
| Shelf life of Chantix... | 5/20/2008 |
| Q: My girlfriend is taking Chantix. She has a prescription of course (and it seems to be working!). ... A: Look at the outside of the carton the Chantix came in. If the expiration date is still within its ... | |
| amoxicillin/clavulanic acid | 5/20/2008 |
| Q: just wanted to ask what exactly is this medication. I tried to look it up but couldn't find ... A: It is a very effective broad spectrum antibiotic. If you Google Augmentin, (make sure you spell it ... | |
| new energy vitamin | 5/2/2008 |
| Q: what is the best way to get my new energy vitamin produced. I know there are thousands of vitamin ... A: The best way would be to find an existing Vitamin manufacturer who is willing to engage in contact ... | |
| Bulk product stability | 5/1/2008 |
| Q: We are using Hexagonal Corrugated boxes with double lined polybags with a desccant bag in between to ... A: Sorry, but I need clarification in order to answer. The Hexagonal Corrugated Boxes - are they used ... | |
| Stability | 4/30/2008 |
| Q: "Dear Mr.Michael/ Ihope that you are in the best mode: I have two questions: 1)If time for ... A: Q1. Seems like you are tying yourself in knots about this. The key question you really need to ask ... | |
| Stability | 4/30/2008 |
| Q: "Dear Mr.Michael/ Ihope that you are in the best mode: I have two questions: 1)If time for ... A: Moayyad: You hope I am in the "best mode" - I am not sure what you mean my this, but I am fine - ... | |
| Raw Material storage requirements | 4/29/2008 |
| Q: what is meant by "Store in cool and dry place" in pharmaceutical raw material storage. We often use ... A: Irfan: According to USP definitions (USP31): "Cool" — Any temperature between 8oC and 15oC (46 ... | |
| test or no the bulk? | 4/10/2008 |
| Q: A bulk of tablets was made 2 months ago. It has been waiting since then to be put in the primary ... A: FDA allows up to 30 days storage without the need for supporting stability data on the bulk. as such ... | |
| preparation of two batches | 4/7/2008 |
| Q: please is it comply to GMP to prepared batche in one holding tank and filled in to two different ... A: A batch is defined as a homogenous mixture. As such your single tank formulation is ONE batch. When ... | |
| Endotoxin | 3/20/2008 |
| Q: What is the significance of testing endotoxins in parentral preperation .the normal limit is found ... A: The presence of endotoxins can cause a cascade of body reactions/degradations leading to death ... | |
| bulk stability | 3/12/2008 |
| Q: We would like to complete bulk stability on our drug product (and/or intermediates) in small fibre ... A: If you drug product is an "active pharmaceutical ingredient" (API), then you can keep your stability ... | |
| Pharmaceuticals | 3/3/2008 |
| Q: we have our client in US having 300 geriatric home with 300 nursing homes and pharmacies they want ... A: For you to export to the USA (and it does not matter that you are selling directly to nursing ... | |
| Filter Validation | 2/28/2008 |
| Q: What is filter validation? What does it inlcudes and When it is required? A: Filter validation relates to studies to demonstrate the suitability of the filter selected for use. ... | |
| UV pass box validation | 2/21/2008 |
| Q: Do we need to validate the time of UV exposure in the pass box? Since all sterilized materials, ... A: UV is not used in passboxes in the USA or in Europe. Better to double wrap the materials being ... | |
| GMP certificate validity period | 2/14/2008 |
| Q: I was wanting to ask this since a long time....the USFDA GMP certificate does not bear a validity ... A: FDA Certificates of GMP do not bear expiration dates because FDA has the attitude that the facility ... | |
| freeze/thaw study necessary | 1/25/2008 |
| Q: We make OTC products (e.g. antiperspirants, dandruff shampoos, zinc oxide, enema, oral laxative, ... A: I used to make these types of products, and we often had customer complaints due to product ... | |
| UV Pass box | 1/22/2008 |
| Q: As it is well known, Uv radiations are not 100 % effective, if used alone as surfaces sanitizing ... A: The pass-through is a closed box. When you open it to place material in from the "C" (dirty) side, ... | |
| UV Pass box | 1/22/2008 |
| Q: As it is well known, Uv radiations are not 100 % effective, if used alone as surfaces sanitizing ... A: Your proposal is "interesting" and very strange. If the materials are double bagged in sterile ... | |
| drug exports | 1/21/2008 |
| Q: What license is required to manufacture prescription drugs in the US for export only to the EU? ... A: Kevin: If you are starting from scratch, then figure 2-3 years to build/equip/validate a facility; ... | |
| drug exports | 1/20/2008 |
| Q: What license is required to manufacture prescription drugs in the US for export only to the EU? A: It makes no difference whether the drug manufactured in the USA is for domestic sale only, or for ... | |
| Stability Commitment | 1/17/2008 |
| Q: A three years ago, we received approval for a product and the first three production batches were ... A: If absolutely nothing, and I do mean nothing, has changed, then there is no need to repeat the long ... | |
| quality control in pharma | 12/30/2007 |
| Q: HOW i can i address failure in analytical instruments calibration failure A: If an analytical instrument fails its calibration (is out-of-tolerance), then you need to do the ... | |
| pharmasceuticals calibrations | 12/30/2007 |
| Q: How calibration of analytical instruments address A: Calibration of instrumentation requires three things: a. use of a reference standard that is ... | |
| Bulk Stability | 11/29/2007 |
| Q: We are using very large pails (0.75 cubic meters volume)to hold our solid dosage products before ... A: if the water vapor transmission rate of the wall of the smaller pail equals that of the bigger pail, ... | |
| Bulk Stability | 11/28/2007 |
| Q: We are using very large pails (0.75 cubic meters volume)to hold our solid dosage products before ... A: The critical questions are: a. how are the bulk pails sealed, and b. what are the storage ... | |
| Retained samples | 11/15/2007 |
| Q: I want to ask about retained samples.When the drug product packed it may have many consignees.Is it ... A: It frequently happens that a single batch of product is packed in the same primary packaging, but ... | |
| Retesting of raw materials | 11/7/2007 |
| Q: Is it accepted to retest the raw materials (API's/ inactives) when it's reach the "expiration date" ... A: Under ICH-Q7 (GMPs for APIs) all APIs and by extension excipients) should have "retest dates". When ... | |
| Why 2-theta and not theta? | 10/11/2007 |
| Q: Why is the X-axis in P-XRD chromatograms expressed in 2-theta instead of theta? A: Rubi: My sincere apologies, but my expertise does not extend to in-depth chemical analysis, ... | |
| Export of UK/EU licensed product to USA | 9/21/2007 |
| Q: Can I export UK/EU licenced product to the US for sale? A: No. You can only export pharmaceutical products (from anywhere in the world) into the USA, when the ... | |
| Analytical method development | 9/11/2007 |
| Q: How to ensure that all the known and unknown impurities of the sample are dissolved in specified ... A: Great Question. The answer is entirely found under the "forced degradation" section of the ICH ... | |
| DMF grade APIs | 9/5/2007 |
| Q: Is DMF grade API different from any standard pharmacopoeia like US/NF or BP ? If yes can it be ... A: There is no such thing as "DMF grade". APIs are manufactured to pharmacopoeia standards. DMF (Drug ... | |
| Augmetin/erythromycin in Jungle and Africa | 8/19/2007 |
| Q: How long can erythromycin and Augmentin last in the bottles that are dispensed from the pharmacy? ... A: Mark: I sympathize, I too travel a lot to Africa and South East Asia, and have the same exact ... | |
| DMF proceedure | 8/16/2007 |
| Q: How does DMF filing works? is it required for both generics & patented drugs? what does a successful ... A: A Drug Master File (DMF) is a way of advising FDA of the manufacture and controls in place, to make ... | |
| UV Sterilization in Pass Box | 7/16/2007 |
| Q: Our company design and manufactures Pass Boxes for Cleanrooms. Recently we have been asked to ... A: Steven: UV lamp pass-throughs have been long ago abandoned in the US and Europe as effective ... | |
| UV Box Validation | 6/27/2007 |
| Q: My company has an UV box that where use to bass eye drops containers, the eye drops containers is ... A: 1. sorry but I do not understand your comment - pls rephrase it; 2. you can use 70% isopropanol as ... | |
| Reg : Validation batches | 6/14/2007 |
| Q: I would like to know whether validation batches can be sold in the local market or is it compulsory ... A: In the USA - if all the validation batches (a minimum of 3) pass all the protocol criteria, the ... | |
| Process validation | 6/9/2007 |
| Q: Is there any legal regulation require studying the first three production batches of a product under ... A: There is a legal requirement in the US and EU that 3 stability batches be prepared, and that 3 ... | |
| expired benzodiazapines | 5/29/2007 |
| Q: i have a full bottle of xanax that was prescribed in 1998 that was left untouched. what would they ... A: Dump them. do not take. As the active ingredient in the Xanax degrades, impurities build up which ... | |
| Expired Marcobid | 5/28/2007 |
| Q: I hope you can answer this - I woke up with a blazing case of Urinary Tract Infection. Of course ... A: When drugs go beyond their expiration date two things happen: a. the active drug degrades, so there ... | |
| Stability study samples | 5/22/2007 |
| Q: Anisfeld Regarding the withdrawn stability study samples at study points, what is the allowable ... A: The timings I provided came from an old FDA guideline from FDA's Office of General Drugs. ... | |
| Stability study samples | 5/20/2007 |
| Q: Anisfeld Regarding the withdrawn stability study samples at study points, what is the allowable ... A: 1, 2, and 3 months samples should be withdrawn and tested with 3 days of the target date; 6, 9, and ... | |
| Ery-Tab 500 mg | 4/9/2007 |
| Q: What is the actual shelf life of erythromycin? I have a bottle that was filled 2-10-06, with ... A: The shelf life (expiration date) of erythromycin can be 1 or 2 years depending on the manufacturer's ... | |
| M.Sc. Pharm Validation Course | 3/27/2007 |
| Q: How valuable would the following course be in the pharma industry, how good of a job would one get? ... A: Your citizenship is not an issue in the pharmaceutical industry, it is however an issue in getting a ... | |
| generic | 3/2/2007 |
| Q: are there any differences between generic and brand name drugs? To be more specific: lamictal vs. ... A: To sell a generic drug, the manufacturer needs to prove to the FDA that the generic is bioequivalent ... | |
| expiration date meds | 1/5/2007 |
| Q: I've been on prednisone off and on for years as treatment for Crohn's disease. I currently have ... A: Kathy: Your pharmacist has a record of the batch number of the prescription that was filled in ... | |
| Alternate to Zolpidem (Ambien) on Canada | 1/2/2007 |
| Q: Do you have any idea why my family physician and pharmacist don't know what it is? And what is the ... A: I have no idea why your local resources do not know about this. The drug is available under the name ... | |
| Calibration curve | 12/20/2006 |
| Q: A question regarding standard concentrations within a calibration curve. If you are going to build ... A: Most folks will build their calibration curve with standards at 25%, 50%, 75%, and 100% (some folks ... | |
| difference | 12/13/2006 |
| Q: what is the difference between drug contraindication and a drug precaution? A: A drug contraindication spells out under what conditions the drug should not be used (e.g. ... | |
| Stability Chamber Excursion | 11/28/2006 |
| Q: Question regarding how to document when we encounter an excursion in the temperature or humidity in ... A: Steve: a. when you have a temp/humidity excursion you do not have a deviation, you have an ... | |
| Ambien/Zolpidem | 11/15/2006 |
| Q: It appears that no form of Zolpidem is available in Canada. I am wondering if there are any ... A: Canada is not the only source of "good" medication available on the Internet. You can also try ... | |
| saline | 11/6/2006 |
| Q: Can you tell me the difference between injectible saline and saline used to treat nasal dryness or ... A: Injectable saline is sterile, while nasal or other saline is not. The danger you have of injecting ... | |
| Expiry dates for Drugs | 10/30/2006 |
| Q: I have the following in my medicine cabinet and I was wondering what the shelf life would be. 1. ... A: Glenda: Most drugs have a two year shelf life, so for the 2004 material - sorry, but junk it. For ... | |
| Qualification of Autoclave | 10/27/2006 |
| Q: USP general Chapters for microbiological testing requires to perfrom temperature mapping of the ... A: Three alternatives are available for temperature profiling "old" 'claves: a. purchase a set of ... | |
| Cleaning | 10/13/2006 |
| Q: What is the best way to clean a tablet compressor machine? Is there any chemical which is allowed? A: You can use any cleaning agent you like as long as: a. it does not interact (e.g. corrode) the ... | |
| Citrate in Calcium Citrate | 9/17/2006 |
| Q: From where is the citrate part of this formulation derived? Is it from natural sources, or can it ... A: Calcium citrate can be extracted from natural sources (with variable impurities and impurity levels ... | |
| Temperature Cycling Studies | 9/15/2006 |
| Q: We generally do Freeze/Thaw studies to determine the impact of extreme environmental (Temp, ... A: I am currently on assignment in China and do not have access to my library. I have done freeze/thaw ... | |
| Stability Chambers | 9/5/2006 |
| Q: If the temperature or humidity drops during an excursion in a stability chamber for an extended ... A: Sunil: This is where your accelerated stability studies can provide information as to the impac of ... | |
| Penicillin | 9/2/2006 |
| Q: Could a layman such as a medical student make Penicillin? A: James: Sure you could, assuming you find the correct strain of organism, and evolve optimum ... | |
| Comarision of US drugs to Canadian | 7/26/2006 |
| Q: I am currently taking a US drug [Fosamax] I can save a lot of money by purchasing it by mail order ... A: Yes you can be sure that the drug is the same, but you need to be sure that you are not getting a ... | |
| Machine operator | 7/23/2006 |
| Q: Is it allowed for a tablet compressor operator to operate two machines manufacturing two different ... A: Assuming that the two tablets compressors are working on different products (even the same product ... | |
| drugs | 7/17/2006 |
| Q: I would like to know the difference between an opiate and morphine... my daughter takes pain ... A: Francesca: An opiate is any drug derived from the Opium poppy. There are over twenty such drugs - ... | |
| Strengths of medicine | 7/14/2006 |
| Q: I understand, But does the mscontin have morphine and oxycontin in it ? And therefore would it be ... A: 60mg Oxycontin contains only oxycontine 30mg morphien contains only morphine they are just ... | |
| Strengths of medicine | 7/14/2006 |
| Q: What medication is stronger ? Morphine 30mg SO4 Or 60mg mscontin A: Your question is a little like "which tastes sweeter - an orange or a pineapple?" Morphine and ... | |
| Acne Treatment | 7/11/2006 |
| Q: , I would just like to know the differences between Roaccutane and the generics (i.e. acnetane & ... A: All drugs, brand name or generic, need to be registered with FDA. In order to sell generic versions ... | |
| medication name changes | 6/24/2006 |
| Q: ----Here is rhe URL regaring the above subject matter. Please read and let me know if you still ... A: As I said, "I think you have been hoaxed". In fact if you go to the very top of the website that ... | |
| Natural Vitamins | 6/14/2006 |
| Q: my doctor says synthetic vitamins are no use at all.my doctor has prescribed vitmain B.He told me to ... A: A doctor studies medicine and is an expert in diseases; a pharmacist study drugs and their actions ... | |
| Natural Vitamins | 6/14/2006 |
| Q: my doctor has prescribed vitmain B.He told me to get a natural vitmain.What does it mean. Is there ... A: Vitamins can be extracted from plants ("naturally derived vitamin"), or manufactured synthically by ... | |
| Sunscreen | 6/8/2006 |
| Q: I was told Neutrogena spf30 and spf45 are good protection when applied frequintly. Is this one of ... A: The higher the SPF number (Sun Protection Factor), the more sun blocking you get, which means the ... | |
| Stability study | 6/4/2006 |
| Q: My inquiry is about redoing stability studies and its causes. I have some cases that may worth ... A: Ahmad: If you change the source of your active ingredient, or of your inactive ingredient - you ... | |
| Synthetic/natural ingrediants | 5/4/2006 |
| Q: I was told that certain ingredients such as Iron, Folic acid, zinc, etc. can be sythesized in a ... A: Teresa: I'm afraid that you are confused about some things: a. naturally occuring elements (iron, ... | |
| Aspirin and Brufen | 4/22/2006 |
| Q: I have been trying to find out the relationship between these two analgesics. Are they related in ... A: Different chemicals work in different ways to effect the same cure - in this case to releve pain. ... | |
| Drug Identification: | 3/12/2006 |
| Q: I found a capsule among my daughters things and can't seem to be able to identify it. It is a light ... A: Take the capsule to your local community pharmacy, where they have identification charts and ... | |
| Drug Companies & HELP! | 3/5/2006 |
| Q: I was wondering if doctors earn some commission for prescribing drugs (even in nursing homes)? I ... A: Pharmaceutical companies spend on average (between all of them) about US$ 7,000 a year on trinkets ... | |
| Pharmacy | 2/13/2006 |
| Q: what are some of the first steps to becoming a top knowledged pharmacist? A: I do not want to sound fascetious, but the first steps are: 1. go to the best pharmacy school, ... | |
| pharmaceutical science | 2/11/2006 |
| Q: What is the role of pharmaceutical science in modern medicine A: ensuring that the drug is formulated such that it gets to the correct location in the body in a ... | |
| Novotriptyn | 2/9/2006 |
| Q: Anisfeld Thank you for taking my question. I would like to know the shelf life of Novotriptyn and ... A: All drug products start to degrade once they are manufactured. The shelf life (expiration dating) is ... | |
| False positive drug tests | 1/24/2006 |
| Q: I'm not sure if you can help me, but I was always told it couldn't hurt to ask. I'm a recruiter for ... A: Debbie: What you inquire about is a perennial problem; especially when we come to the Olympic ... | |
| Medication Temperature Range | 1/24/2006 |
| Q: Michael, Knowing that the medication temperature storage range recommended by the USP is 59-86 ... A: Bill: In order to provide a product's exiration date, manufacturers are required to perform ... | |
| plasma expander | 1/4/2006 |
| Q: we attempt to build a pharmaceutical factory to produce parenteral solutions .we would be most ... A: We are a consulting company that specializes in the design, building, and the start-up of ... | |
| Drug research? | 11/19/2005 |
| Q: Let's say, a doctor is seeing a patient who has a history of chest pain, high cholesterol, ... A: The quickest and easiest way to study this effect is: a. to a group of patients exhibiting the ... | |
| Flu Vaccine | 11/12/2005 |
| Q: How do the experts know what flu virus will be around each year far enough in advance to prepare the ... A: There are several strains of influenza virus. Every year the World Health Organization (WHO) makes ... | |
| Business in Pharmacy | 9/19/2005 |
| Q: I will end my pharmacy education within the mid. of the next month. Then i want to start my own ... A: Without knowing you, your likes and dislikes, how can I even begin to answer that question? All I ... | |
| pill id | 8/5/2005 |
| Q: Vintage Pharmaceuticals, an oblong white w/green specks tablet with 3594 printed on one side and the ... A: Raymond: In the time it took you to write to me, if you had gone on Google and entered "tablet ... | |
| Manufacture | 7/19/2005 |
| Q: Is there a difference in medication makeup between manufacturers? For example, would the active and ... A: Kent: Each manufacturer can purchase the active anywhere they want, so long as each active ... | |
| Piercing | 7/17/2005 |
| Q: Um I did somehting stupid...I'm 14...I pierced the top of my ear by myself with a needle soaked in ... A: Lauren: As a pharmacist, it sounds to me like you might have a very serious ear infection, which ... | |
| Vitamins-Minerals | 7/5/2005 |
| Q: I've learned where our soils have been depleted of minerals from wind, leaching, poor farming ... A: If the soil were depleted, then the plants would not grow. As a pharmacist I have to tell you that ... | |
| Pharmaceuticals | 7/4/2005 |
| Q: 1)What is MOC for filter bags used in FBD.What is the pore size of those bags? Is there any ... A: To answer your questions: 1. please elaborate on what is MOC; but companies typically do a visual ... | |
| time release | 6/25/2005 |
| Q: what happens when you chew a time released pill? does it all take effect right away or is it still ... A: Different time release dosage forms work in different ways. If it the tablet coating that is ... | |
| coumadin/warfarin | 6/18/2005 |
| Q: Since your expertise is in manufacturing and technology, answer me this question. Is the ... A: If your Coumadin was manufactured by a pharmaceutical company registered with the Mexican ... | |
| film coating | 6/18/2005 |
| Q: What we have to do in film coating? Is there any type of aquous coating? What we have to do in ... A: Film coating is extremely complex, and an answer is beyond the scope of this forum. The best text ... | |
| Prandin Expiration Dates | 6/17/2005 |
| Q: I get Prandin from Liberty Medical and it works fine for me but I notice it always has an expriation ... A: No pharmaceutical company would EVER manufacture a drug with a 6 month shelf life (stability); the ... | |
| Lariam | 6/8/2005 |
| Q: in a couple of weeks i am going to be deployed as an UN Military Observer in Sudan. I was given a ... A: First let me wish you luck on your assignment - and a very diificut one. If I can assist from my ... | |
| drug imports | 5/18/2005 |
| Q: I am consulting to a German online pharmacy. They wish to have a list of the top-selling drugs that ... A: Richard: I have no idea where such a list can be found, BUT .... there are many sources to find ... | |
| Ferrous Sulohate and Black Faeces | 5/11/2005 |
| Q: I know that Ferrous Sulphate tablets cause the stool to turn black but WHY does this occurr? Thanks A: Facetously I'd say that you have rusty stools. No, but seriously, blood carries oxygen, but needs ... | |
| user requirements and designe qualifications | 4/13/2005 |
| Q: how are the URS detremined, then how can we review the designe(how can we qualify the design?), ... A: User Requirement Specifications (URS) relates to equipment; and are determined by you, based on what ... | |
| hi | 4/7/2005 |
| Q: Good morning,could u please tell me the name of science dealing with cream synthesis and are there ... A: The science of the properties of creams in termed "rheology". There is no specific name for the ... | |
| Protonix vs. Nexium | 3/27/2005 |
| Q: When my medical clinic changed my priscription from "prilosec" to "nexium", It was my understanding ... A: Donald: Nexium is Astra-Zeneca's confidence trick on the US public. Nexium is the optical isomer of ... | |
| vaccine production process | 2/15/2005 |
| Q: This statement was made on an on-line forum. Is it true? What I am interested in is if aborted ... A: Absolute BULL! I worked for a company making these vaccines. They are grown on chicken eggs - we ... | |
| Identify Slimming pill | 2/14/2005 |
| Q: I ordered from a medical company over the internet 1 mths supply of Phentermine (generic). I have ... A: I am a member of the World Health Organization anti-counterfeit drugs task force. What you describe ... | |
| free foreign generics | 1/30/2005 |
| Q: and thanks for taking my question. After reading 'Mountains Beyond Mountains,' I began thinking more ... A: You've just got your facts plain wrong. When a drug goes off patent, someone still has to make it ... | |
| lifesaverforu@yahoo.com | 1/8/2005 |
| Q: sir how many mg or micro grams are equal to one I.U? e.g.how many mg are found in one I.U of vit D? ... A: You are confusing two units of measure - IU is activity, mg is weight. In many drugs you express ... | |
| Lortab | 12/15/2004 |
| Q: My grandmother has been diagnosed with pancreatic cancer and has been prescribed Lortab for pain; ... A: Yes, you can crush the tablets. Also you can dissolve the now crushed tablet - the powder - in ... | |
| Dear Michael, What happens... | 12/4/2004 |
| Q: What happens when someone orders prescription medication online from another country? What are the ... A: Thea: You can order medication on the internet, however there is a very good chance that your ... | |
| Dilantin | 11/13/2004 |
| Q: My wife has taken dilantin for several years due to a stroke and a seizure disorder. About a year ... A: Generic Dilantin has been demonstrated to FDA to be bioequivalent to Phenytoin. Hence scientifically ... | |
| Synagis costs | 11/12/2004 |
| Q: Can you tell me why Medimunne can charge so much money for the RSV vaccine for my child? Is there ... A: The USA is the only country in the world that does not, as government policy, cap the price of drugs ... | |
| Pharcmacy Tech. | 11/12/2004 |
| Q: before looking at shcools, i'm interested in be coming a Pharmacy tech do you know their yearly ... A: Sorry I only make the drugs, I do not dispense them, so I have no answer to your question. But a ... | |
| i was just wondering if you... | 10/13/2004 |
| Q: i was just wondering if you could help me with an assignment that I have started. it was one of ... A: Fascinating question, and one that I truely wish I could assist on, but your field is absolutely and ... | |
| Herbal and Alternative Medicines | 9/27/2004 |
| Q: ------------------------- Thank you for responding. I guess my question was a little vague. ... A: First separate in your mind herbal medication from homeopathic - they are very different. ... | |
| Betadine Surgical Scrub | 9/17/2004 |
| Q: For years I have been using Betadine Surgical Scrub for washing myself as I am prone to skin ... A: Sorry - I'm too much of a pharmacist, and I missed the obvious. The scrub is a 4% soultion, the ... | |
| Anti Malarial Medication | 9/11/2004 |
| Q: My family and I will be travelling to Mexico in November for a month. It is my understanding that, ... A: My expertise is in making drugs, not in how they are used; so I am sorry but I cannto assist you. ... | |
| Prescription Drug discount card | 8/27/2004 |
| Q: Are you aware of any really significant discount card on the market? I am searching for a ... A: Check whether your state has a subsidized drug propgram that you might qualify for; or alternately ... | |
| Suspensions | 8/18/2004 |
| Q: I am just trying to find information on products made of gels in pharmacy for a research project and ... A: Lib: Two great texts you should consult are: a. "Theory and Practice of Industrial Pharmacy", by ... | |
| drug names | 7/30/2004 |
| Q: My wife takes Tegretol XR. Is Tegretol CR, which is sold in Canada the same. If not what is the ... A: XR - CR, these are marketing terms. Probably XR stands for eXtended Release, while CR means ... | |
| Armour vs generic thyroid | 6/26/2004 |
| Q: Even though I've been told at Wal-Mart that my generic thyroid pill is the same as the Armour ... A: Your Wal-Mart generic drug is chemically identical to the brand name, and what you are suffering ... | |
| expired chemicals | 6/6/2004 |
| Q: how r u doing?i would like to inquire about the standard way in management of xpired chemical ... A: For chemicals beyond their retest date, you can try any of these possibilities: a. do full ... | |
| Penicillin G Procaine | 6/4/2004 |
| Q: I am wondering what happens to Penicillin G Procaine if it is not kept at a cool tempurature. In ... A: Trevor: Check the storage conditiond stated on the product label, and store it at those temps. If ... | |
| generic vs brand med | 5/12/2004 |
| Q: Hope I'm in the right dept. with my question, here goes: I'm 59, female... diagnosis= ... A: Regretfully your pharmacist might be an expert on the actions of drugs but he/she knows very little ... | |
| A Theory on Drug Abuse | 4/13/2004 |
| Q: I have heard a theory on talk radio recently that there will always be about a 10% drug ... A: Regretfully I have never heard of this theory and could not comment on it. But what I would say is ... | |
| wrong prescription | 3/30/2004 |
| Q: I recently moved to Texas, and due to worsening allergies, was prescribed Singular 10. However, ... A: Wendy: What I suggest you do is: a. speak to your physician and get his input into this eggregious ... | |
| Pharmaceutical Fish Oil? | 1/29/2004 |
| Q: I have read recently recommendations from various people about using "pharmaceutical fish oil" as ... A: In thirty years working in pharmacy, I have never heard the term "pharmaceutical fish oil". If by ... | |
| Generic Pharmacutical Quality Assurance | 1/12/2004 |
| Q: Micheal, Originally I was given samples of Alprazolam .500mcg from my Doctor. These samples were ... A: Several things could be going on here: a. your doctor could have changed the medication without ... | |
| Possible drug misdose. | 12/17/2003 |
| Q: I was recently prescribed an antibiotic for occasional acne breakouts. Upon taking this I ... A: With all medications the amount of drug stated on the label (in your case 100mg) refers to the ... | |
| help | 10/5/2003 |
| Q: heres a sentence from a job spec i have an interview for soon. "Aside from the release testing ... A: The sentence refers to analytical testing that is required to comply with FDA drug manufacturing and ... | |
| Good Storage Practice in pharmaceutical industry | 8/19/2003 |
| Q: i would like to inquire about a certain issue related to GMP requirments; Is there any document or ... A: Sorry for the delay in responding, but I have just today got back from 10 days without internet ... | |
Pharmaceuticals
Answers by Expert:
Michael Anisfeld
Top Expert on this page
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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements
Experience
Past/Present Clients
UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
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