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Pharmaceuticals/Questions
| Subject | Date Asked | Expert |
| INSTRUMENTS CALIBRATION | 2/7/2012 | Michael Anisfeld |
| Q: When an instrument is shifted from one location to other location may be in same premise like ... A: Great Question. The answer as to why some instruments need recalibration after being moved from ... | ||
| API Vs product Expiry Dating | 2/2/2012 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 ... | ||
| question | 1/22/2012 | Dr Mohd Tariq Salman |
| Q: I'm wondering what medicine would work better and be safer, xanax or ativan, or something else. I ... A: Both are safe when used for short periods. The risk of suicide only occurs after prolonged use. Both ... | ||
| Repackaging | 1/16/2012 | Michael Anisfeld |
| 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 ... | ||
| Clonidine and Reynauds syndrome | 1/2/2012 | Patricia Morrow |
| Q: I recently was on a clonidine patch for 24 hours and got very bad side effects. I took it for ... A: Carol, This is a most difficult question. Clonidine has a short half-life, meaning that it is ... | ||
| GMP/accumulation of lots | 12/27/2011 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 ... | ||
| Dosage of Epilim | 12/20/2011 | Dr Mohd Tariq Salman |
| Q: Doctor, I am 50 years old, married with two children,and never suffered from epilepsy. However in ... A: Epilim Chrono is a prolonged release formulation of Epilim which reduces peak concentration and ... | ||
| Shelf life of drug products | 12/20/2011 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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. ... | ||
| expired Chantix | 12/1/2011 | Patricia Morrow |
| Q: I have an unopened starter box of Chantix that was prescribed to me a few years ago. I never opened ... A: Jen, First see if the doctor will prescribe you a new Rx of Chantix, tell them you never opened it ... | ||
| The difference between artificial tears and eye drops | 11/25/2011 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 ... | ||
| alendronate ("Fosamax") | 10/27/2011 | Dr Mohd Tariq Salman |
| Q: I understand that in the half hour following my weekly dose of alendronate (upon arising), I should ... A: You should take Alendronate by mouth on an empty stomach in the morning at least 30 minutes before ... | ||
| GMP | 10/26/2011 | Michael Anisfeld |
| 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 ... | ||
| sideeffects of drugs | 10/22/2011 | Dr Mohd Tariq Salman |
| Q: I have been on Budesonide EC 3mg Cap 2x daily (I have been on this for 2 years) and Trexall 15mg one ... A: Confusion is because of Budesonide, and it should be taken seriously. Getting off Budesonide will be ... | ||
| sideeffects of drugs | 10/22/2011 | Patricia Morrow |
| Q: I have been on Budesonide EC 3mg Cap 2x daily (I have been on this for 2 years) and Trexall 15mg one ... A: Don, Trexall is methotrexate, and is used long-term for rheumatoid arthritic joint disorders. You ... | ||
| MDI Shot Weight Test | 9/16/2011 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 ... | ||
| drug interactions | 8/7/2011 | Dr Mohd Tariq Salman |
| Q: I take the following drugs: bupropion hcl 100mg, hydrochlorothiazide 25mg, gabapentin 600mg, ... A: There is risk of serious drug interactions between bupropion, fluoxetine and trazodone. The use of ... | ||
| stability alarm system | 8/3/2011 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 | Michael Anisfeld |
| 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 ... | ||
| activated carbon/charcoal | 5/31/2011 | Patricia Morrow |
| Q: what is your take on activated carbon/charcoal? the internet is full of fans of the substance. since ... A: Amber, Activated charcoal is a good product to use, mainly because it "rides" through the digestive ... | ||
| other medication for dh | 5/30/2011 | Dr Mohd Tariq Salman |
| Q: I had a reaction to dapsone what other medication is there for it A: Other regimens include : 1] monthly administration of a combination consisting of 600 mg of ... | ||
| skip testing | 5/18/2011 | Michael Anisfeld |
| 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 ... | ||
Pharmaceuticals
Answers by Expert:
Michael Anisfeld
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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
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UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
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