| Subject | Date Asked | Expert |
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| Hi | 7/10/2008 | Michael Anisfeld |
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 ...
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| Hi | 7/10/2008 | Michael Anisfeld |
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 ...
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| Sampling conditions for non sterile raw materials | 7/10/2008 | Michael Anisfeld |
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. ...
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| Stability samples transfer | 7/9/2008 | Michael Anisfeld |
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 ...
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| FBD bag | 6/6/2008 | Michael Anisfeld |
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 ...
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| Shelf life of Chantix... | 5/20/2008 | Michael Anisfeld |
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 ...
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| amoxicillin/clavulanic acid | 5/20/2008 | Michael Anisfeld |
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 ...
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| new energy vitamin | 5/2/2008 | Michael Anisfeld |
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 ...
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| Bulk product stability | 5/1/2008 | Michael Anisfeld |
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 ...
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| Stability | 4/30/2008 | Michael Anisfeld |
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 ...
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| Stability | 4/30/2008 | Michael Anisfeld |
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 - ...
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| Raw Material storage requirements | 4/29/2008 | Michael Anisfeld |
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 ...
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| test or no the bulk? | 4/10/2008 | Michael Anisfeld |
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 ...
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| preparation of two batches | 4/7/2008 | Michael Anisfeld |
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 ...
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| Endotoxin | 3/20/2008 | Michael Anisfeld |
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 ...
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| bulk stability | 3/12/2008 | Michael Anisfeld |
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 ...
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| Pharmaceuticals | 3/3/2008 | Michael Anisfeld |
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 ...
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| Filter Validation | 2/28/2008 | Michael Anisfeld |
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. ...
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| UV pass box validation | 2/21/2008 | Michael Anisfeld |
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 ...
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| GMP certificate validity period | 2/14/2008 | Michael Anisfeld |
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 ...
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| freeze/thaw study necessary | 1/25/2008 | Michael Anisfeld |
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 ...
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| UV Pass box | 1/22/2008 | Michael Anisfeld |
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, ...
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| UV Pass box | 1/22/2008 | Michael Anisfeld |
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 ...
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| drug exports | 1/21/2008 | Michael Anisfeld |
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; ...
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| drug exports | 1/20/2008 | Michael Anisfeld |
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 ...
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| Stability Commitment | 1/17/2008 | Michael Anisfeld |
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 ...
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| quality control in pharma | 12/30/2007 | Michael Anisfeld |
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 ...
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| pharmasceuticals calibrations | 12/30/2007 | Michael Anisfeld |
Q: How calibration of analytical instruments address
A: Calibration of instrumentation requires three things: a. use of a reference standard that is ...
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| Bulk Stability | 11/29/2007 | Michael Anisfeld |
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, ...
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| Bulk Stability | 11/28/2007 | Michael Anisfeld |
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 ...
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| Retained samples | 11/15/2007 | Michael Anisfeld |
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 ...
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| Retesting of raw materials | 11/7/2007 | Michael Anisfeld |
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 ...
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| Why 2-theta and not theta? | 10/11/2007 | Michael Anisfeld |
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, ...
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| Export of UK/EU licensed product to USA | 9/21/2007 | Michael Anisfeld |
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 ...
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| Analytical method development | 9/11/2007 | Michael Anisfeld |
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 ...
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| DMF grade APIs | 9/5/2007 | Michael Anisfeld |
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 ...
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| Augmetin/erythromycin in Jungle and Africa | 8/19/2007 | Michael Anisfeld |
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 ...
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| DMF proceedure | 8/16/2007 | Michael Anisfeld |
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 ...
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| UV Sterilization in Pass Box | 7/16/2007 | Michael Anisfeld |
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 ...
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| UV Box Validation | 6/27/2007 | Michael Anisfeld |
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 ...
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