Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What are the expectations for second-person review of data entry in the laboratory including weighing, adding, etc.? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the difference between official and established specifications? Are these terms interchangeable? 1.76K 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? 1.51K 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? 1.37K 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? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Should raw materials have traceability so as to establish the raw material history, etc.? 1.50K 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? 1.76K 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? 1.29K 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? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Will API firms be held accountable to these guidelines even though operations were conducted prior to effective date of Q7A? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans In which document does one designate the API starting material, the drug master file or some other filing application? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it necessary to complete any investigations including out of specification investigations (OOS), prior to release of product? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans What types of controls are expected if the calibration of equipment is contracted to outside agencies? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding computer validation, is it necessary to second check all data into the computer system or only the critical data? 1.50K viewsFDA 0 Votes 1 Ans Revalidation of computerized systems. What is required for computerized materials management systems used to monitor receipts, sampling testing or release of materials? 1.60K viewsFDA 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? 1.69K 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? 1.41K 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? 1.33K 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? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Please expand on what is acceptable as true copies. Do you mean actual reproductions in place of originals, scanned records, or validated computer system accepted by the FDA? 1.71K viewsFDA « Previous 1 2 … 263 264 265 266 267 … 283 284 Next » Question and answer is powered by anspress.net
