Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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 0 Votes 1 Ans Does the ICH provide guidance on the determination of cleaning limits, residual limits? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans What does adequate protection in Section 4.1 and adequate filtration in Section 4.2 mean? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Is Purified Water or Water for Injection the quality of water you are requiring or recommending for use in API production? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Permanently installed pipework identification: would documentation be a P&ID, or would a process flow diagram be an adequate substitute for labeling individual lines? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Which engineering steps during the planning of a new API plant should be kept, documented, and verified? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the manufacture of API’s require the establishment of air quality standards, HVAC systems specifications to insure no dust migration during the charging of components used in API manufacturing from one reactor to another? 1.42K viewsDrugsPharmaceutical « Previous 1 2 … 73 74 75 76 77 … 79 80 Next » Question and answer is powered by anspress.net
