Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is cleaning qualification sufficient? Would cleaning validation be expected once the API manufacturing was commercial and not clinical? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Is cleaning validation required before the API starting material? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the minimum adequate interval for monitoring a validated cleaning process? 1.79K 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? 1.83K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to calibrate non-critical equipment? 1.75K 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? 1.61K 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? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you need to calibrate non-critical equipment? 1.75K 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? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans There are several questions here that relate to standards for clean room classes and are asking about regulations or specific guidances that identify either where they’re needed or about design requirements for room classifications, Class 10,000, etc. 1.72K 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? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans “What do you recommend in terms of status indicators for production equipment? Give me examples.” 1.86K 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? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the performance of preventive maintenance required for each piece of GMP equipment? 1.78K viewsDrugsPharmaceutical 0 Votes 1 Ans Under preventive maintenance, is it acceptable to let certain equipment to go to failure, such as piping, manual valves, etc? 1.81K viewsDrugsPharmaceutical 0 Votes 1 Ans Are flexible hoses that are repeatedly used considered major equipment, therefore requiring maintenance? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A provide for the matrix approach to equipment cleaning validation, or are companies expected to perform a separate cleaning validation for each compound? 1.90K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it expected to establish a maximum time elapsed from the end of processing to cleaning? 1.83K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there an expectation to establish time limits for clean equipment before that equipment needs to be recleaned? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Cleaning methods – are you looking for the active ingredient, the raw material, and byproduct in the cleaning methods? 1.46K viewsDrugsPharmaceutical « Previous 1 2 … 73 74 75 76 77 … 82 83 Next » Question and answer is powered by anspress.net
