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)”? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans If a product fails its particulate matter specifications, can it be released for sale? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Are the United States Pharmacopoeia (USP) general notices enforceable? 1.25K 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? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable for firms to export expired drugs for charity? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans Explain the United States Pharmacopoeia (USP) measurement uncertainty (MU) requirement for balances. 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Can an older version of an official method be used or must the most updated version always be used? 978 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? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Why GHX? 1.50K 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? 1.18K 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? 1.11K 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? 1.25K 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? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the acceptable deviation in physical counts of finished product stock? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans When are independent checks by another operator necessary? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the expectations on label accountability? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Is verification of empty containers an acceptable check for addition of ingredients? 942 viewsDrugsPharmaceutical 0 Votes 1 Ans Are quarantine and release stickers required on all containers of raw materials and packaging materials? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an answering machine acceptable for recall activation outside normal working hours? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to document quantities by lot numbers of finished stock destroyed? 1.14K viewsDrugsPharmaceutical « Previous 1 2 … 195 196 197 198 199 … 283 284 Next » Question and answer is powered by anspress.net
