Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 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? 1.96K 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? 1.56K viewsBanking and FinancePharmaceutical 0 Votes 1 Ans Is there a list or reference available that defines objectionable organism? 1.89K viewsDrugsPharmaceutical 0 Votes 1 Ans Why was the validation protocol not used as a source document for defining critical parameters? 2.02K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the group’s opinion of detergent cleaning versus solvent cleaning? 1.85K viewsDrugsPharmaceutical 0 Votes 1 Ans Solvents used for cleaning equipment. May these be recovered? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Visual and analytical verification after cleaning, is one exclusive to the other? 1.62K 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? 1.76K 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? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Is cleaning qualification sufficient? Would cleaning validation be expected once the API manufacturing was commercial and not clinical? 1.64K 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? 1.83K viewsDrugsPharmaceutical 0 Votes 1 Ans Is cleaning validation required before the API starting material? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the minimum adequate interval for monitoring a validated cleaning process? 1.49K 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? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Vendors of new equipment often ship you a vessel that has been polished. Often they do not know the chemical constitutes of the polish or of the gases. Our approach to cleaning, in this case, is use of a non-polar solvent to remove organics followed by a polar solvent to remove inorganics. Is this acceptable? 1.59K 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? 1.82K viewsDrugsPharmaceutical 0 Votes 1 Ans Wherever possible, food grade lubricants and oils should be used. Does that mean it’s okay to get into the batch? 2.00K viewsDrugsPharmaceutical 0 Votes 1 Ans What do you recommend in terms of status indicators for production equipment? 1.83K viewsDrugsPharmaceutical 0 Votes 1 Ans What was EWG’s thinking along the lines of consumable items such as inline filters, O – rings and gaskets? Is there an expectation that they are treated as job aids or equipment? 1.78K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the performance of preventive maintenance required for each piece of GMP equipment? 1.60K viewsDrugsPharmaceutical « Previous 1 2 … 6 7 8 9 10 … 82 83 Next » Question and answer is powered by anspress.net
