Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Is there a standard on what should be stated in a recall procedure? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans May firms omit second person component weight check if scales are connected to a computer system? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a company required to notify the Inspectorate of a change in key personnel, such as the person in charge of Quality Control (QC) or manufacturing department? 1.15K viewsFDA 0 Votes 1 Ans Is fumigation a requirement under sanitation? 997 viewsFDA 0 Votes 1 Ans Are gowning rooms required even in pilot plant operations? 1.23K viewsFDA 0 Votes 1 Ans In terms of cleaning, what would be the frequency and type of cleaning for equipment and premises for successive manufacturing of batches of the same product? And for different strengths of the same product? 1.33K viewsFDA 0 Votes 1 Ans Clothing: Is it acceptable to have two levels of clothing in the non-sterile manufacturing areas, i.e., one level for operators with full gowning and coveralls and another level for QA auditors and visitors? What environmental monitoring data is required? 1.18K viewsFDA 0 Votes 1 Ans Can the sampling for the microbial monitoring of air in non-sterile areas where susceptible products are produced be conducted when there are no manufacturing packaging activities? 1.21K viewsFDA 0 Votes 1 Ans Must written procedures be available to prevent objectionable microorganisms in drug products not required to be sterile? 1.16K viewsFDA 0 Votes 1 Ans What are requirements of maintaining an impurity profile? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Does every individual container of a raw material need to be sampled for identification (ID) purposes regardless of the number of containers of the same lot available or are composite samples acceptable provided they are obtained from a maximum of 10 containers? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans An active pharmaceutical ingredient (API) can be used after the retest date assigned by the API fabricator if a re-analysis done immediately before use shows that it still meets its specifications. Can the new data generated be used by the drug fabricator to assign a longer retest date to future lots of this API obtained from the same fabricator? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans What about inactive ingredients? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans With respect to the re-test date of the drug substances, we have the stability data of a drug substance for up to 24 months at real time stability condition. The re-test period is assigned up to 24 months. According to the “Evaluation of Stability Data – ICH Q1E”, 2.4.1.1(the proposed retest period or shelf life can be up to twice, but should not be more than 12 months beyond, the period covered by long-term data), the retest period can be assigned up to 36 months. Can we assign the retest period up 36 months? If yes, does it require retesting of the active pharmaceutical ingredient (API) at 24 months? 936 viewsDrugsPharmaceutical 0 Votes 1 Ans We are a subsidiary of a United States (US) corporation. This US corporation supplies us with active pharmaceutical ingredients (APIs) that are fully tested after receipt on its premises. Can the US site be certified for the purpose of testing exemptions for the Canadian site? 861 viewsDrugsPharmaceutical 0 Votes 1 Ans Are control standard endotoxins still acceptable for use in running bacterial endotoxins tests? 1.17K viewsFDA 0 Votes 1 Ans What is Penicillin? 1.22K viewsFDA 0 Votes 1 Ans What are the Penicillin drugs? 1.09K viewsFDA 0 Votes 1 Ans Is cross-contamination a concern with penicillin drugs? 1.27K viewsFDA 0 Votes 1 Ans Are there special manufacturing requirements for Penicillin drugs? 1.13K viewsFDA « Previous 1 2 … 196 197 198 199 200 … 283 284 Next » Question and answer is powered by anspress.net
