Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Should GMP according to ICH Q7 be applied for manufacturing Steps before the defined ‘API starting material’ i.e., Steps not identified in grey in Table 1? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an acceptability study required for each specific formulation? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans Any specific packaging and labelling requirements? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any FPP specification requirements for zinc sulfate formulations? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans How to conduct an Solubility testing? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Effects of excipients on zinc absorption? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a bioequivalence study report required? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Is evidence of Marketing Authorization required to demonstrate that the product is registered or approved for sale in accordance with national requirements? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans How much evidence is required as proof of validation of the manufacturing process of the FPP? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans At product changeover, are both visual examination and analytical testing necessary to verify that equipment is clean? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it expected that campaign manufacturing be addressed in cleaning validation? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it expected that equipment cleaning time limits be confirmed in cleaning validation? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Should acceptance criteria for residues be defined for dedicated equipment? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans For dedicated equipment, is ‘visually clean’ acceptable for verification of cleaning effectiveness, (i.e., no expectation for specific analytical determination)? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans To what extent can quality risk management be used in establishing appropriate containment measures to prevent cross-contamination? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans When are dedicated production areas expected? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Does ICH Q7 expect the use of a consultant and can a company delegate tasks and/or responsibility to a consultant? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the intent of the statement in [ICH Q7, Section 3.12] ‘training should be periodically assessed’? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Should the product quality review of results include trend analysis? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be the frequency of a product quality review? 1.60K viewsDrugsPharmaceutical « Previous 1 2 … 64 65 66 67 68 … 79 80 Next » Question and answer is powered by anspress.net
