Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 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)? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the acceptable media fill frequency in relation to the number of shifts? Normally, media fills should be repeated twice per shift per line per year. Is the same frequency expected of a process conducted in an isolator? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products? 1.81K viewsDrugsPharmaceutical 0 Votes 1 Ans How can manufacturers assess and address the risk of microbiological contamination of topical antiseptics? 1.58K viewsDrugsPharmaceutical 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? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans Best method for designing a statistically sound sample plan for a pharmaceutical packaging process? – In the packaging process we are looking at several different attributes varying from critical defectives (AQL .065) to minor defectives (AQL 1.5). It is the goal to use one sample size that would statistically cover the different AQL range. If we have a batch size of 20,000 and a samples size of 315, would it be safe to say that the pass/reject level for AQL .065, 0-1 and 10-11 for an AQL 1.5. Is it statistically sound that we just pull one sample size? 1.48K viewsDrugsPharmaceutical 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? 1.72K viewsDrugsPharmaceutical 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)? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans ANDA OTC, prescription RLD NDA approved products – Can there be an ANDA OTC? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Monographed product changes reporting -How do you report changes if you have a monographed product? 1.82K viewsDrugsPharmaceutical 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? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Post approval change requirements of monographed products 1.70K viewsDrugsPharmaceutical 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. 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the guidelines on correcting an entry or errors after an analysis or a process is complete? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans When doing microbial counts, is using negative controls that succeed proof enough that testing is not the issue? 1.84K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you recommend daily flushing of POU drops that are not routinely used? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there an ideal or recommended number of POU drops that are included in a distribution loop? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans How often is sanitization of typically recommended? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans If the WFI distribution system circulates at 85 degrees C , is sanitization required? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you recommend any special strategy for evaluating increasing the interval between routine sanitization for system that has been operating without issues? 1.59K viewsDrugsPharmaceutical « Previous 1 2 … 14 15 16 17 18 … 82 83 Next » Question and answer is powered by anspress.net
