Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Can Leptospira species penetrate sterilizing-grade filters? If so, what should manufacturers keep in mind in their ongoing lifecycle risk management efforts to ensure microbial control? 1.36K viewsPharmaceutical 0 Votes 1 Ans FDA withdrew its draft guidance for industry on Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment. What were the Agency’s major concerns with this guidance? 1.63K viewsPharmaceutical 0 Votes 1 Ans Why is FDA concerned about proper sampling of powder blends? 1.34K viewsPharmaceutical 0 Votes 1 Ans What are some recommended innovative approaches to ensuring adequacy of mixing of powder blends? 1.74K viewsPharmaceutical 0 Votes 1 Ans What are the Agency’s recommendations regarding in-process stratified sampling of finished dosage units? 1.61K viewsPharmaceutical 0 Votes 1 Ans Is it generally acceptable from a CGMP perspective for a manufacturer of sterile drug products produced by aseptic processing to rely solely on ISO 14644-1 and ISO 14644-2 when qualifying its facility? 1.72K viewsPharmaceutical 0 Votes 1 Ans In 2004, FDA issued a guidance entitled PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance that encouraged industry to modernize manufacturing through enhancements in process control. How can I implement PAT (process analytical technology)? 1.67K viewsPharmaceutical 0 Votes 1 Ans What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products? 1.77K viewsPharmaceutical 0 Votes 1 Ans How can manufacturers assess and address the risk of microbiological contamination of topical antiseptics? 1.54K viewsPharmaceutical 0 Votes 1 Ans Monographed product changes reporting -How do you report changes if you have a monographed product? 1.39K viewsPharmaceutical 0 Votes 1 Ans OTC drug registration-U.S. agent requirements and responsibilities – In order to register an OTC drug in the U.S. does the U.S. agent have to physically live or operate a business in the U.S. or can this agent live elsewhere? 1.69K viewsPharmaceutical 0 Votes 1 Ans Post approval change requirements of monographed products – Post approval change requirements of monographed products 1.54K viewsPharmaceutical 0 Votes 1 Ans We are a start-up biotech company and need to set-up a raw materials testing program. Final product labels are our current priority. 1.60K viewsPharmaceutical 0 Votes 1 Ans What are the guidelines on correcting an entry or errors after an analysis or a process is complete? 1.56K viewsPharmaceutical 0 Votes 1 Ans Do pharmaceutical manufacturers need to have written procedures for preventing growth of objectionable microorganisms in drug products not required to be sterile? What does objectionable mean anyway? 1.56K viewsPharmaceutical 0 Votes 1 Ans If a GLP inspector requests information retained in an archive, can a test facility respond by retrieving electronic records from a company’s global electronic archiving system (physically located in another country)? 1.53K viewsPharmaceutical 0 Votes 1 Ans Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse? 1.35K viewsPharmaceutical 0 Votes 1 Ans Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes. Is this okay? 1.69K viewsPharmaceutical 0 Votes 1 Ans Do CGMPs require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution? 1.64K viewsPharmaceutical 0 Votes 1 Ans If there is dead biofilm present in the water system, will this show itself with higher TOC counts? 1.57K viewsPharmaceutical « Previous 1 2 … 80 81 82 83 Next » Question and answer is powered by anspress.net
