Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What is the difference between official and established specifications? Are these terms interchangeable?. 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans To what level of detail should the manufacturing master production instructions be written with the assumption that the operator has a Ph.D. or is totally ignorant? 1.84K viewsDrugsPharmaceutical 0 Votes 1 Ans A batch record should be checked before it is issued to production. Can this check be done by production or must it be done by quality? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Does batch record generation software have to be Part 11 compliant? Can Microsoft products be used to generate these batch records? Do batch record generation programs have to be validated? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans Should raw materials have traceability so as to establish the raw material history, etc.? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you expect to see an official document from the API manufacturer describing the starting material and its position in the synthetic pathway? 1.83K viewsDrugsPharmaceutical 0 Votes 1 Ans Cleaning records, maintenance records don’t appear to have to be reviewed or checked anymore by a second person or supervisor. Is this true? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Review of critical process steps. Is the complete review of the batch record for a critical process step, meaning a synthetic step, or is it a review of the critical variables within the critical step? 1.81K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to calibrate non-critical equipment? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it the expectation of Q7A that equipment should be calibrated before and after a preventive maintenance is done on a piece of equipment? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans What types of controls are expected if the calibration of equipment is contracted to outside agencies? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A consider 21 CFR Part 11, and what is the regulatory status for compliance when inspecting an API manufacturer? Does Q7A specifically address or imply compliance requirements? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Master batch instructions written by a word processor using something like Microsoft Word, then printed, reviewed and approved as a hard copy, which is signed and dated. True or false, is this an electronic record? 1.84K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 4.2 requires utility system drawings be available. What level of documentation/drawings is expected? Are piping and instrumentation diagrams sufficient, or are drawings showing actual dimensions expected? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans The CGMP regulations for drug products, 21 CFR 211, specify a written record of major equipment cleaning, maintenance, and use shall be included in the individual equipment logs. Q7A does not specify individual equipment logs, only records. Does this mean individual equipment logs are no longer necessary/ expected for API manufacturing? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans What microbial controls is the manufacturer required to have in place for an API used in clinical trials for parenteral drug product even if the manufacturer has no responsibility for the end use of the API? 1.82K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the list of raw materials need to include a list of filters and other commodities? Does Q7A require control of durables and consumables? 1.50K viewsBanking and FinancePharmaceutical 0 Votes 1 Ans Is there a list or reference available that defines objectionable organism? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans Why was the validation protocol not used as a source document for defining critical parameters? 1.86K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the group’s opinion of detergent cleaning versus solvent cleaning? 1.74K viewsDrugsPharmaceutical « Previous 1 2 … 53 54 55 56 57 … 283 284 Next » Question and answer is powered by anspress.net
