Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What are the requirements in terms of monitoring/testing for the release of sterile gowns to be used in a controlled environment (Grades A or B) when those are obtained from a supplier? 961 viewsDrugsPharmaceutical 0 Votes 1 Ans What are the room classification requirements for the preparation of containers and other packaging materials to be used in the fabrication of sterile products? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans For the validation of moist heat sterilization cycles, will the new standards include the use of prions as the organism of choice instead of Bacillus stearothermophilus? 1.29K viewsDrugsPharmaceutical 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? 1.25K viewsDrugsPharmaceutical 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? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Is GMP necessary if there is a quality control laboratory? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Can manufacturers afford to implement GMP? 858 viewsDrugsPharmaceutical 0 Votes 1 Ans Why is GMP important? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Poor quality medicines can damage health 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans GMP helps boost pharmaceutical export opportunities? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the person in charge of quality control have to sign Quality Control (QC) data and documents? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans If electronic signature is not validated, must the signed paper copy be available? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans What is considered an adequate sample when tank loads of a raw material is received? 1.14K 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? 1.25K 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? 1.21K 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? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Do batches have to be tested for preservatives at initial release and then in the continuing stability program? 825 viewsDrugsPharmaceutical 0 Votes 1 Ans Can it be assumed that United States Pharmacopoeia (USP) chromatographic assay methods are stability indicating? 953 viewsDrugsPharmaceutical 0 Votes 1 Ans Is it acceptable to place an expiry date on a bottle cap instead of on the bottle label? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans When the labelled expiration date states only the month and year does it mean the end of the month? 1.11K viewsDrugsPharmaceutical « Previous 1 2 … 37 38 39 40 41 … 79 80 Next » Question and answer is powered by anspress.net
