Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is quality important in the pharmaceutical and medical device industry? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the planning and preparation of both quality and safety in the pharmaceutical and medical device industry? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is Strong observation skills required in the pharmaceutical and medical device industry? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Why does the U.S. Food and Drug Administration (FDA) requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans If water that has already been used in compounding is later found to contain endotoxins, what actions need to be taken? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Are sterile products in amber glass and plastic ampoules exempt from 100% visual inspection? 919 viewsDrugsPharmaceutical 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 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? 1.09K 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? 1.20K 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 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 electronic signature is not validated, must the signed paper copy be available? 1.18K viewsDrugsPharmaceutical « Previous 1 2 … 37 38 39 40 41 … 82 83 Next » Question and answer is powered by anspress.net
