Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Why did the DOL make this change? 1.63K viewsHuman Resources 0 Votes 1 Ans Should an Excel spreadsheet be validated that is used for trending of stability data? 1.57K viewsFDA 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 if I pay some of my bills through automatic bill pay? 1.23K viewsHuman Resources 0 Votes 1 Ans Will I need to make any changes to my tax withholding? 1.58K viewsHuman Resources 0 Votes 1 Ans What is the Fair Labor Standards Act (FLSA)? 1.59K viewsHuman Resources 0 Votes 1 Ans What are my requirements as the employer to pay attendants for sick time, paid vacations, and holidays? 1.66K viewsHuman Resources 0 Votes 1 Ans Are there any exemptions from the FLSA Overtime requirements? 1.45K viewsHuman Resources 0 Votes 1 Ans What is my requirement for Overtime Pay under the FLSA regarding Sleep Time for my attendants? 1.68K viewsHuman Resources « Previous 1 2 … 265 266 267 268 269 … 283 284 Next » Question and answer is powered by anspress.net
