Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 1.08K 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? 1.24K 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? 1.16K 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? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans Can new retest dates continue to be assigned if material remains? 938 viewsDrugsPharmaceutical 0 Votes 1 Ans Can the user assign retest dates later than manufacturer’s expiration date? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Do we need to keep reserve samples of starting materials used in API manufacturing? Do they need to keep samples of intermediates if they’re not marketed? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Is validation data required in support of blending? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans A company wants to manufacture a blend of chemical actives, where no chemical synthesis extraction occurs. This blend is then sold for use in the manufacture of a consumer product. Is this blend considered an API or does API starting material manifest itself? 981 viewsDrugsPharmaceutical 0 Votes 1 Ans Could you elaborate on section 12.6? Would a change in the source of an API starting material require revalidation? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the quality section need to sign off / approve the validation reports in addition to validation protocols? 957 viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A address process development reports? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you give examples of appropriate documentation or other alternate means to indicate the status of equipment? 808 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between “witness” and “verify” in Q7A? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Drug Product Manufacturers may produce placebo product during the PQ-phase to demonstrate the process and equipment are functioning prior to manufacturing commercial product. What is expected in performing a PQ in an API facility? 1.06K viewsDrugsPharmaceutical « Previous 1 2 … 231 232 233 234 235 … 283 284 Next » Question and answer is powered by anspress.net
