Questions Ask question Search Order By: ActiveCategoryClear Filter 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)”? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans If a product fails its particulate matter specifications, can it be released for sale? 1.03K viewsDrugsPharmaceutical 0 Votes 1 Ans Are the United States Pharmacopoeia (USP) general notices enforceable? 1.21K 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? 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable for firms to export expired drugs for charity? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Explain the United States Pharmacopoeia (USP) measurement uncertainty (MU) requirement for balances. 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Can an older version of an official method be used or must the most updated version always be used? 934 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Inspectorate’s position on the use of secondary reference standards (RS) and what are the conditions for the use of secondary reference standards? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Why GHX? 1.39K viewsMedical Device 0 Votes 1 Ans What documentation does a laboratory have to have in place to be considered qualified to run a test method for raw materials (drug substances and excipients) in order to satisfy Health Canada Regulations? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the sampling plan based on the (/n+1) acceptable for identifying the number of containers of raw material to be sampled? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans If we already test each batch of our finished product for the absence of Staphylococcus aureus and Pseudomonas aeruginosa, is it required to test it also for the purified water? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a single lot number be assigned to two or more co-mingled lots of bulk finished drug products packaged during the same run? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the acceptable deviation in physical counts of finished product stock? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans When are independent checks by another operator necessary? 980 viewsDrugsPharmaceutical 0 Votes 1 Ans What are the expectations on label accountability? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Is verification of empty containers an acceptable check for addition of ingredients? 894 viewsDrugsPharmaceutical 0 Votes 1 Ans Are quarantine and release stickers required on all containers of raw materials and packaging materials? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an answering machine acceptable for recall activation outside normal working hours? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to document quantities by lot numbers of finished stock destroyed? 1.09K viewsDrugsPharmaceutical « Previous 1 2 … 195 196 197 198 199 … 283 284 Next » Question and answer is powered by anspress.net
