Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 1.45K viewsDrugsPharmaceutical 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? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a batch numbering system need to be sequential? 1.61K 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’? 1.59K 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 « Previous 1 2 … 65 66 67 68 69 … 79 80 Next » Question and answer is powered by anspress.net
