Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Why aren’t bulk deliveries of chemicals used in API manufacturing held to the same standards as APIs? There is no validation of clean outs for non-dedicated tankers. 2.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Is statistical sampling a lot for raw materials used for production of APIs sent to Europe? 1.95K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between evaluating suppliers of critical material in Section 7.1, and the supplier approval evaluation discussed in Section 7.3? Does Section 7.3 pertain to all materials or just critical materials? 1.93K viewsDrugsPharmaceutical 0 Votes 1 Ans Sampling and testing states that, “No testing necessary for special materials if . . .” Please define special materials in this context. 1.99K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding Alternate method for rejected material, is it okay not to have a separate area? 2.02K viewsDrugsPharmaceutical 0 Votes 1 Ans Where do gases fall, i.e., nitrogen for the blanket, as a raw material or process aid? Do they require material management control, quarantine, ID testing, etc? 2.22K viewsDrugsPharmaceutical 0 Votes 1 Ans What is Bedoyecta used for? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans Under Section 7.3, third paragraph, “describe other special materials.” These are materials excluded from testing. Does the company define the special materials? If so, on what basis? 1.85K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an appropriate system to allow a material’s use while still under quarantine? What makes a conditional release appropriate? 2.06K viewsDrugsPharmaceutical 0 Votes 1 Ans When incoming materials are mixed with existing stocks, for example, solvents. How can a distinctive batch or receipt number be meaningful for purposes of tracking materials used in a specific production batch? And, how useful is assigning batch numbers to such materials when they are mixed? 1.95K viewsDrugsPharmaceutical 0 Votes 1 Ans Is black ink pen, which looks like photocopying, acceptable for filling in data in batch records? 1.98K viewsDrugsPharmaceutical 0 Votes 1 Ans Equipment cleaning and use records. For multi-use, non-dedicated equipment, is it acceptable to have these records as part of the batch record or is a separately maintained record required. 1.89K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the section on equipment cleaning and use records (section 6.2) apply to lab equipment in the laboratory. For example, HPLCs, balances, GCs, etc.? 1.89K viewsDrugsPharmaceutical 0 Votes 1 Ans For an existing registered process, is the starting material listed in the drug master file registration the starting material for Q7A?” 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans Control data requests that you retain data on the preparation and testing of reference standards. Since many of the reference standards are purchased, how can one accomplish this? 2.01K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it appropriate in a batch record to have large spaces, i.e., pages, for handwritten comments to be entered to document observations, etc., as well as spaces for entering data, i.e., tables. 2.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Does every operation in a critical step automatically become subject to QA record review? 1.95K viewsDrugsPharmaceutical 0 Votes 1 Ans If an API has an impurity, does the dosage form manufacturer have the responsibility to identify it if the API manufacturer provides a C of A? Which of the two does FDA hold legally responsible? 2.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a batch numbering system need to be sequential? 2.03K viewsDrugsPharmaceutical 0 Votes 1 Ans Do isolated synthetic intermediates intended for use in the next process step need to be quarantined and released by the quality unit? 1.95K viewsDrugsPharmaceutical « Previous 1 2 3 4 5 6 7 … 79 80 Next » Question and answer is powered by anspress.net
