Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What are the Agency’s recommendations regarding in-process stratified sampling of finished dosage units? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans For a nonsterile compendial drug product that includes an antimicrobial preservative in its formulation, may I release and market lots of this drug product with initial out-of-specification total aerobic plate counts if these lots test within specification 2 weeks later? 1.49K 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? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Can Total Organic Carbon (TOC) be an acceptable method for detecting residues of contaminants in evaluating cleaning effectiveness? 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans A firm has multiple media fill failures. They conducted their media fills using TSB (tryptic soy broth) prepared by filtration through a 0.2 micron sterilizing filter. Investigation did not show any obvious causes. What could be the source of contamination? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the cleaning validation requirements for potent compounds (e.g., compounds that are cytotoxic, mutagenic, or have high pharmacologic activity), and is dedicated equipment required? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Does equipment need to be clean enough to meet limits based on the most sensitive possible methods of residue detection or quantification? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Do firms need to quantify the total amount of residue remaining on equipment surfaces after manufacturing a product (before cleaning) to support cleaning validation studies? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Should laboratory glassware be included in a firm’s equipment cleaning validation program? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the role of the quality unit in approving changes to master production instructions during clinical trials? What is the quality unit’s role in reviewing and approving the master production instructions in phase I and phase II? 1.73K viewsClinical Research 0 Votes 1 Ans Do the CGMPs require a firm to retain the equipment status identification labels with the batch record or other file? Assuming each major piece of equipment has a unique cleaning and use log that is adequately retained, is it acceptable to discard these quick reference equipment labels? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans A firm has multiple media fill failures. They conducted their media fills using TSB (tryptic soy broth) prepared by filtration through a 0.2 micron sterilizing filter. Investigation did not show any obvious causes. What could be the source of contamination? 1.39K viewsDrugsPharmaceutical 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? 1.73K viewsDrugsPharmaceutical 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 viewsDrugsPharmaceutical 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? 1.73K viewsDrugsPharmaceutical 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)? 1.46K 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? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans What specific CGMP regulations might be useful to manufacturers of topical antiseptic drug products? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans How can manufacturers assess and address the risk of microbiological contamination of topical antiseptics? 1.51K viewsDrugsPharmaceutical « Previous 1 2 … 61 62 63 64 65 … 283 284 Next » Question and answer is powered by anspress.net
