Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Are on-site audits required in the evaluation of suppliers? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans What is meant by ‘full analysis’ [ICH Q7, Section 7.31] on batches of raw materials to qualify a supplier? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans What is expected in terms of evaluation of suppliers of materials? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the phrase ‘grouping of containers’ have the same meaning in [ICH Q7, Sections 7.20 and 7.24]? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is responsible for the issuance of batch production records? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a batch numbering system need to be sequential? 1.62K viewsDrugsPharmaceutical 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’? 1.60K 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? 1.31K 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? 1.52K 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)? 1.67K 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? 1.54K 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 « Previous 1 2 … 247 248 249 250 251 … 283 284 Next » Question and answer is powered by anspress.net
