Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Can accelerated stability data of less than three months be used? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans Should drugs packaged into kits and subsequently sterilized, be tested for stability? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the supervisor of a sterile product manufacturing facility need to have a degree in microbiology? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Should compendial test methods be validated? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Must all identification tests stated in a compendial monograph be performed? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Are solid dosage drugs exempted from dissolution testing if sold under a manufacturer’s standard? 775 viewsDrugsPharmaceutical 0 Votes 1 Ans Do products labelled as United States Pharmacopoeia (USP) have to be tested as per the USP test methods? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be the calibration frequency for a dissolution apparatus used with both baskets & paddles? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans In performing system suitability as per United States Pharmacopoeia (USP) <621>, do all replicate injections have to be completed before any analyte sample injections are made? 859 viewsDrugsPharmaceutical 0 Votes 1 Ans Is routine product pH testing required for endotoxin (limulus amebocyte lysate – LAL) testing? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the use of recycled solvents for high performance liquid chromatography (HPLC) columns acceptable? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans If one lot of a product made in a Mutual Recognition Agreement (MRA) country is split into two separate shipments, is it mandatory for the importer to obtain separate manufacturer’s batch certificate for each shipment? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to perform the testing, including the potency, before packaging or is it mandatory to perform this testing after packaging? 1.21K viewsDrugsPharmaceutical 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? 1.12K 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? 971 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 « Previous 1 2 … 38 39 40 41 42 … 79 80 Next » Question and answer is powered by anspress.net
