FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Why is FDA Cracking Down on Homeopathic Drugs? 1.50K viewsFDA 0 Votes 1 Ans What are the new Enforcement Approaches to Homeopathic Drugs? 1.37K viewsFDA 0 Votes 1 Ans What are the Upcoming Changes to FDA Electronic Medical Device Reporting (EMDR) ? 1.36K viewsFDA 0 Votes 1 Ans What are the 4 Document Control Gaps That Can Cause Big Problems and How to Avoid Them? 1.05K viewsFDA 0 Votes 1 Ans What is “Network Drives and Email” document control gaps and what you can do to fix them? 1.25K viewsFDA 0 Votes 1 Ans What is “Lack of Integration” document control gaps and what you can do to fix them? 1.27K viewsFDA 0 Votes 1 Ans What is “Audit Problems” document control gaps and what you can do to fix them? 1.11K viewsFDA 0 Votes 1 Ans Is a company required to notify the Inspectorate of a change in key personnel, such as the person in charge of Quality Control (QC) or manufacturing department? 1.23K viewsFDA 0 Votes 1 Ans Is fumigation a requirement under sanitation? 1.09K viewsFDA 0 Votes 1 Ans Are gowning rooms required even in pilot plant operations? 1.31K viewsFDA 0 Votes 1 Ans In terms of cleaning, what would be the frequency and type of cleaning for equipment and premises for successive manufacturing of batches of the same product? And for different strengths of the same product? 1.50K viewsFDA 0 Votes 1 Ans Clothing: Is it acceptable to have two levels of clothing in the non-sterile manufacturing areas, i.e., one level for operators with full gowning and coveralls and another level for QA auditors and visitors? What environmental monitoring data is required? 1.28K viewsFDA 0 Votes 1 Ans Can the sampling for the microbial monitoring of air in non-sterile areas where susceptible products are produced be conducted when there are no manufacturing packaging activities? 1.30K viewsFDA 0 Votes 1 Ans Must written procedures be available to prevent objectionable microorganisms in drug products not required to be sterile? 1.26K viewsFDA 0 Votes 1 Ans Are control standard endotoxins still acceptable for use in running bacterial endotoxins tests? 1.28K viewsFDA 0 Votes 1 Ans What is Penicillin? 1.32K viewsFDA 0 Votes 1 Ans What are the Penicillin drugs? 1.18K viewsFDA 0 Votes 1 Ans Is cross-contamination a concern with penicillin drugs? 1.37K viewsFDA 0 Votes 1 Ans Are there special manufacturing requirements for Penicillin drugs? 1.23K viewsFDA 0 Votes 1 Ans Are firms required to use high-efficiency particulate air (HEPA) filters for air supply in areas used for the manufacture of non-sterile dosage forms? 1.08K viewsFDA « Previous 1 2 … 50 51 52 53 54 … 75 76 Next » Question and answer is powered by anspress.net
