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? 1.38K 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 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. 1.54K 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? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans “What do you recommend in terms of status indicators for production equipment? Give me examples.” 1.69K 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? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the performance of preventive maintenance required for each piece of GMP equipment? 1.60K 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? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Are flexible hoses that are repeatedly used considered major equipment, therefore requiring maintenance? 1.29K 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? 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it expected to establish a maximum time elapsed from the end of processing to cleaning? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there an expectation to establish time limits for clean equipment before that equipment needs to be recleaned? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Cleaning methods – are you looking for the active ingredient, the raw material, and byproduct in the cleaning methods? 1.30K viewsDrugsPharmaceutical « Previous 1 2 … 73 74 75 76 77 … 82 83 Next » Question and answer is powered by anspress.net
