Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What are the minimum testing requirements for solid dosage drugs? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the standards other than the United States Pharmacopoeia (USP) that have official status in Canada? 1.17K 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? 1.22K 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? 1.26K 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)? 1.05K 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? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Inspectorate’s position on 2-mercaptobenzothiazole (MBT) in rubber closures? 1.28K 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? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Can industrial grade nitrogen be used as a blanketing agent during the manufacture of a drug product? 1.25K 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? 895 viewsDrugsPharmaceutical 0 Votes 1 Ans For a contract fabricator, is it a requirement to test the raw materials offered by customers? 1.20K 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? 1.15K 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? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans How long in advance can the raw materials be weighed? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans If a licensed packager/labeller is packaging a drug for a foreign establishment which is not intended to be sold in Canada as described under Section 1.0 of “Conditions for Provision of Packaging/Labelling Services for Drugs under Foreign Ownership (GUI-0067)”? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans If a product fails its particulate matter specifications, can it be released for sale? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Are the United States Pharmacopoeia (USP) general notices enforceable? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans If a lot meets United States Pharmacopoeia (USP) specifications but fails the firm’s internal specifications, can it be released? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable for firms to export expired drugs for charity? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Explain the United States Pharmacopoeia (USP) measurement uncertainty (MU) requirement for balances. 1.31K viewsDrugsPharmaceutical « Previous 1 2 … 39 40 41 42 43 … 79 80 Next » Question and answer is powered by anspress.net
