Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Does the supervisor of a sterile product manufacturing facility need to have a degree in microbiology? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Should compendial test methods be validated? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Must all identification tests stated in a compendial monograph be performed? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Are solid dosage drugs exempted from dissolution testing if sold under a manufacturer’s standard? 872 viewsDrugsPharmaceutical 0 Votes 1 Ans Do products labelled as United States Pharmacopoeia (USP) have to be tested as per the USP test methods? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be the calibration frequency for a dissolution apparatus used with both baskets & paddles? 1.39K 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? 958 viewsDrugsPharmaceutical 0 Votes 1 Ans Is routine product pH testing required for endotoxin (limulus amebocyte lysate – LAL) testing? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the use of recycled solvents for high performance liquid chromatography (HPLC) columns acceptable? 1.27K 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? 1.14K 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? 1.30K 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? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Must standard operating procedures (SOP) referenced in master production documents (MPD) be available at the importer’s premises? 1.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Can chromatograms be stored on disc instead of retaining the hard copy? 970 viewsDrugsPharmaceutical 0 Votes 1 Ans If your clinical trial is coming to an end and you are moving into a commercial setting to recruit patients, do you still need to get IRB approval on media materials used commercially? 1.49K viewsClinical Research 0 Votes 1 Ans How should the packaging of IMP be performed? 1.63K viewsClinical Research 0 Votes 1 Ans How should the packaging be documented? 1.54K viewsClinical Research 0 Votes 1 Ans How should the containers be labelled? 1.70K viewsClinical Research 0 Votes 1 Ans How should IMP administration to the subjects be documented? 1.71K viewsClinical Research 0 Votes 1 Ans Can a sponsor prospectively approve deviations (so-called “protocol waivers”) from the inclusion/exclusion criteria of the approved protocol without additional approval of the ethics committee and competent regulatory authority? 1.50K viewsClinical Research « Previous 1 2 … 137 138 139 140 141 … 283 284 Next » Question and answer is powered by anspress.net
