Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Should an Equipment Use Log be maintained for non-dedicated equipment? Should it include listing which piece of equipment was used for that particular product at that particular moment? 1.52K viewsMedical Device 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? 1.58K 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 0 Votes 1 Ans Please elaborate the definition of dedicated equipment. Equipment used on a campaign during six months can be considered dedicated during this period. Does cleaning validation apply if change of product is forecasted? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to calibrate non-critical equipment? 1.59K 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? 1.30K viewsDrugsPharmaceutical « Previous 1 2 … 264 265 266 267 268 … 283 284 Next » Question and answer is powered by anspress.net
