Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What is meant by ‘completely distributed’ in [ICH Q7, Section 6.13], which states that ‘records should be retained for at least 3 years after the batch is completely distributed’? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Can quality defects of released APIs that are identified by another entity belonging to the same company be handled outside of the API manufacturer’s complaint procedure? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Is validation expected for the recovery of material from mother liquor? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the definition of expiry date in ICH Q7 preclude the rework or reprocess of an expired API? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Should rejected materials be stored under physical and secure segregation? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is responsible for notifying the drug product manufacturer about relevant changes in API manufacturing? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a retrospective approach to validation still acceptable? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Would additional process validation studies be needed to support a change in the source of an API starting material? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Can the range of a process parameter be expanded based only on a process deviation(s)? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the lifecycle approach to process validation acceptable for APIs under ICH Q7? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Why does ICH Q7 permit the use of a packaging system for reserve/retention samples that is ‘more protective than the marketed packaging system’ [ICH Q7, Section 11.72]? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by ‘completely distributed’ in [ICH Q7, Section 11.71], which indicates reserve/retention samples should be retained for 3 years after the batch is completely distributed by the manufacturer? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans When is it acceptable for an API manufacturer to extend an API retest date [ICH Q7, Section 11.6]? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans In cases where an API test method is changed, which method should be used for stability studies already in progress? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a software supplier have to be audited at all events, or would it be sufficient if the supplier filled in a questionnaire which would then be assessed by the QA unit? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans In which intervals do systems have to be validated? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Are the terms ‘deviation’ and ‘non conformance’ synonyms? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it permitted to use the same equipment to manufacture materials to be used in pre-clinical and clinical trials? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Do [ICH Q7, Sections 18.14, 18.2] apply to classical fermentation and biotechnology? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Does ICH Q7 expect validation for viral removal/viral inactivation steps for biological/biotechnological products? 1.63K viewsDrugsPharmaceutical « Previous 1 2 … 66 67 68 69 70 … 82 83 Next » Question and answer is powered by anspress.net
