Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is the retest date calculated from the manufacturing date or from the release date? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a conflict of retest date definitions among ICH, Q7A and Q1A with respect to immediate use? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Are retains of raw materials used to make APIs necessary or required? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans FDA’s March 1998 draft GMP guidance for API manufacturing defined for antibiotics the use of expiry date. Q7A does not have this recommendation, is this difference existing or not? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans What happens if it is not possible to identify an impurity? A new one or one detected…? What happens if it’s just not possible to identify the impurity? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans (Follow-up from floor) That would depend upon the stability of the material? 947 viewsDrugsPharmaceutical 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? 1.01K 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? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans When, if ever, is parametric release of Intermediates allowed, either to skip testing or reduce testing? 955 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? 1.24K viewsDrugsPharmaceutical « Previous 1 2 … 49 50 51 52 53 … 82 83 Next » Question and answer is powered by anspress.net
