Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 1.64K 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? 1.34K 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? 1.28K 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? 1.45K 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? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a list or reference available that defines objectionable organism? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Why was the validation protocol not used as a source document for defining critical parameters? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans What degree of validation should be necessary when data is recorded on a computer and a second system, i.e. paper batch record? Differences could exist in the degree of accuracy on the computer versus the paper. Also, in deciding if a deviation is critical, would one normally expect to see what requirements are critical versus non-critical predefined in the production instructions? If not, what justification would you expect to see? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 6.5 says, “. . . should include complete information relating to production,” yet clarification to 6.3 says “. . . short document for recording results;” please explain the discrepancy. 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the group’s opinion of detergent cleaning versus solvent cleaning? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans Solvents used for cleaning equipment. May these be recovered? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans Visual and analytical verification after cleaning, is one exclusive to the other? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans For a non-sterile API intended for use in a sterile drug product, what level of equipment sanitization and/or sterilization is expected and how verified? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Is cleaning validation expected to take place when the first batches are produced for commercial use (process validation), even when such batches are produced on a pilot or small scale? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Is cleaning qualification sufficient? Would cleaning validation be expected once the API manufacturing was commercial and not clinical? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans Is cleaning validation required before the API starting material? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the minimum adequate interval for monitoring a validated cleaning process? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans After calibration and/or maintenance of a process unit, is it required to clean the unit before use for processing? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to calibrate non-critical equipment? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding use of equipment for pre-clinical and clinical, is it allowable to use the same equipment for both as long as all operations are conducted under Q7A and as long as the worse case scenario is considered for cleaning? 1.46K viewsDrugsPharmaceutical « Previous 1 2 … 72 73 74 75 76 … 79 80 Next » Question and answer is powered by anspress.net
