Questions Ask question Search Order By: ActiveCategoryClear Filter 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 0 Votes 1 Ans Does ICH Q7 expect that sampling be performed by the quality unit? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Can other departments outside of the quality unit be held responsible for releasing raw materials and intermediates? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans What is expected in terms of impurities for APIs extracted from herbal or animal tissue origin [ICH Q7, Section 11.2]? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by ‘APIs and intermediates can be transferred under quarantine to another unit under the company’s control when…’and is this applicable to contract manufacturers? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by ‘appropriate specifications (of each batch) prior to blending’ [ICH Q7, Section 8.41]? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Can yield ranges defined for the first batch differ from latter batches within a campaign? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it possible to extend the expiry date or retest date of a raw material and what is the acceptable practice to determine how long it may be extended for? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Which tests are considered to be identity tests? 1.44K viewsDrugsPharmaceutical « Previous 1 2 … 246 247 248 249 250 … 283 284 Next » Question and answer is powered by anspress.net
