Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Can a retest date be extended without stability data? Can you think of a situation where that might occur? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans (Section 11.2.) Should specs be set for non-critical Intermediates? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans You mentioned that validated methods are not required for raw material testing. Does this mean from Step I materials to the raw materials that enter the final API production step, even the API starting material? Are tests other than ID also required? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an API brought into the country without an expiry date or a retest date on the label of C-of-A considered misbranded? And, is it held on entry in customs? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 11.2, Pharm Forum recently proposed AMC (Aerobic Microbial Count) specifications for all API. Is this appropriate? 1.00K viewsDrugsPharmaceutical 0 Votes 1 Ans If the inspector asks you to provide the basis for using a three-month-old reference solution in the stability testing of a specific API, what experience and scientific judgment do you defend the utilization of that material? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Shouldn’t all APIs intended for sterile use normally have a specification for microbiological content? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans When, if ever, is parametric release of Intermediates allowed, either to skip testing or reduce testing? 953 viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A address the need for product-specific Master Plan or the Validation Master Plan? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Should companies maintain accountability of reference standards in the QA labs, i.e. a log of every use amount and date of the reference standard, that is reconciled with the amount of reference standard received. Is this a general expectation? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans Please give some examples of when an expiry date rather than a retest date would be required for an API. 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans If the API manufacturer must retain a sample of each batch – and so must the drug product manufacturer under 21 CFR 211, – can the API manufacturers retained sample satisfy both requirements? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans If retention samples are stored in more protective conditions, they are no longer representative of the product in the market. In the case of a complaint from the customer, how can we defend our product in the market with samples stored in better conditions than the product itself? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the expectation for retention samples for bulk drug product, for further packaging, not in the final package, the same as for APIs in Q7A? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there an annual inspection expectation for retention samples similar to the ones expected or required for drug products? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans We test water for endotoxins for a non-sterile API that is sold for further processing to produce a sterile product. Should we also test the API itself for endotoxins? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a chain of custody for reference standard materials? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans This is in regard to a slide 11-5 in laboratory operations, which said that you had to have a procedure for sampling. Was that referring to a sampling procedure for obtaining a bulk sample from the lot or was that referring to sampling that bulk sample for use in the laboratory? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans If a process has several purification steps and the first step fails to meet specifications, but this can be corrected by adjustment in a subsequent step, is an OOS investigation needed for this first step? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Can new retest dates continue to be assigned if material remains? 934 viewsDrugsPharmaceutical « Previous 1 2 … 49 50 51 52 53 … 79 80 Next » Question and answer is powered by anspress.net
