Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear 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? 1.17K viewsDrugsPharmaceutical 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? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans What about inactive ingredients? 1.01K 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? 859 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? 934 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Objective of CAPA Preventive Action? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans What is CAPA Preventive Action Closing Date? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans How to do Documentation and CAPA Preventive Action? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the CAPA – The Process that It Follows? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans How to Check the Effectiveness of CAPA? 935 viewsDrugsPharmaceutical 0 Votes 1 Ans What is DMAIC – Another Process of Measuring Effectiveness of CAPA? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Should QbD training be Implemented? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the Viral Safeties of Pharmaceutical Compliance? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans What is Radiopharmaceuticals? 980 viewsDrugsPharmaceutical 0 Votes 1 Ans What is Toxicology in Drug Development? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the Pharmaceutical Compliance Regulations? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs? 987 viewsDrugsPharmaceutical « Previous 1 2 … 41 42 43 44 45 … 82 83 Next » Question and answer is powered by anspress.net
