Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans A product is manufactured in a non-Mutual Recognition Agreement (non-MRA) country, then shipped in bulk in a MRA country where it is packaged and tested before being released and exported to Canada. Would the testing exemption provided by Interpretation 4 under C.02.019 Finished Product Testing apply? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Must standard operating procedures (SOP) referenced in master production documents (MPD) be available at the importer’s premises? 935 viewsDrugsPharmaceutical 0 Votes 1 Ans Can chromatograms be stored on disc instead of retaining the hard copy? 876 viewsDrugsPharmaceutical 0 Votes 1 Ans Does the Inspectorate encourage the use of environmental isolates for preservative effectiveness testing? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans Should an inspector observe and question a technician’s analytical work? 973 viewsDrugsPharmaceutical 0 Votes 1 Ans Does the official method DO-25 apply to tablets labelled as being professed or as manufacturer’s standard? 962 viewsDrugsPharmaceutical 0 Votes 1 Ans Do tests for impurities have to be repeated for finished products if they have been done on the raw materials? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the minimum testing requirements for solid dosage drugs? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the standards other than the United States Pharmacopoeia (USP) that have official status in Canada? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to use a third party lab’s available pharmacopeial reference standard to qualify an establishment’s secondary standard? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Inspectorate’s position on the use of loose work sheets as opposed to bound notebooks for the purpose of recording laboratory data? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans It is generally accepted in the industry to perform process validation on three consecutive lots. How does the Inspectorate view validation when reworking is required (i.e., three consecutive incidents will never happen)? 943 viewsDrugsPharmaceutical 0 Votes 1 Ans Is it mandatory for the approval of a procedure to sign each page or is it acceptable to only sign the first page? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Inspectorate’s position on 2-mercaptobenzothiazole (MBT) in rubber closures? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to include a chemical identification test in a specification for a packaging component (such as a plastic bottle)? Must this chemical identification (ID) be conducted for each lot received? Would vendor certification be considered an acceptable substitution for testing upon receipt? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Can industrial grade nitrogen be used as a blanketing agent during the manufacture of a drug product? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Do bacteriostasis and fungistasis testing have to be performed for each lot of product in reference to the United States Pharmacopoeia (USP) sterility test? 788 viewsDrugsPharmaceutical 0 Votes 1 Ans For a contract fabricator, is it a requirement to test the raw materials offered by customers? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans If the customer asks a contract fabricator not to test a finished product, is it necessary for the contract fabricator to test the product? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a contract fabricator or packager responsible for qualification of utilities and systems and cleaning validation or is it the responsibility of the distributor? And what about the validation of the manufacturing/packaging process and test methods? 1.03K viewsDrugsPharmaceutical « Previous 1 2 … 39 40 41 42 43 … 82 83 Next » Question and answer is powered by anspress.net
