Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans According to the monograph on parenteral products (0520) of the 4th edition (2002) of the European Pharmacopeia (Ph. Eur.), injections for veterinary use with a volume dose of less than 15 mL are exempted from bacterial endotoxins/pyrogen testing by the European Union (EU). Is this interpretation correct? If so, would this EU exemption be applicable in Canada? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans For radiopharmaceuticals, can it be acceptable to verify the integrity of the sterilizing filter only after use and to not perform the pre-filtration integrity testing? 1.28K viewsPharmaceutical 0 Votes 1 Ans What is the Inspectorate’s position on pooling of samples within the same batch (e.g., 7 samples in one pool) for testing for sterility? The European Pharmacopoeia (Ph. Eur.) does not mention explicitly a pooling of samples for testing for sterility? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Is GMP necessary if there is a quality control laboratory? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans Can manufacturers afford to implement GMP? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is GMP important? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Poor quality medicines can damage health 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans GMP helps boost pharmaceutical export opportunities? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the person in charge of quality control have to sign Quality Control (QC) data and documents? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans According to Section C.02.020 Records, documents to be kept by the fabricator, packager/labeller, distributor and importer must be stored on their premises in Canada. In the case of a distributor or importer particularly, these documents are sometimes kept only on the premises of a consultant hired to provide Quality Control (QC) services, therefore they are not available on the premises of the distributor or importer at the time of the inspection. Is this practice acceptable? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans If electronic signature is not validated, must the signed paper copy be available? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans What is considered an adequate sample when tank loads of a raw material is received? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans A pressurized tanker of hydrocarbon raw materials (isobutane, propane, etc.) is normally sampled and approved before pumping. What is the current Inspectorate policy for sample retention given the inherent risks generated by these flammable gases under pressure? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans If a product is fabricated in Canada and exported outside of Canada (the product is not sold on the Canadian market), are samples of this finished product to be retained in Canada? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Do batches have to be tested for preservatives at initial release and then in the continuing stability program? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans Can it be assumed that United States Pharmacopoeia (USP) chromatographic assay methods are stability indicating? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to place an expiry date on a bottle cap instead of on the bottle label? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans When the labelled expiration date states only the month and year does it mean the end of the month? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Can accelerated stability data of less than three months be used? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Should drugs packaged into kits and subsequently sterilized, be tested for stability? 1.40K viewsDrugsPharmaceutical « Previous 1 2 … 136 137 138 139 140 … 283 284 Next » Question and answer is powered by anspress.net
