Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Do manufacturers of OTC products have to report quality defects? 1.53K 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 Is this okay? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans FDA withdrew its draft guidance for industry on Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment.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? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is FDA concerned about proper sampling of powder blends? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans What are some recommended innovative approaches to ensuring adequacy of mixing of powder blends? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the Agency’s recommendations regarding in-process stratified sampling of finished dosage units? 1.61K 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? 1.43K 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? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Can Total Organic Carbon (TOC) be an acceptable method for detecting residues of contaminants in evaluating cleaning effectiveness? 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? 1.70K 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? 1.40K 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? 1.52K 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? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans Should laboratory glassware be included in a firm’s equipment cleaning validation program? 1.32K viewsDrugsPharmaceutical 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? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse? 1.56K 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? 1.33K 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? 1.67K 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? 1.57K 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? 1.66K viewsDrugsPharmaceutical « Previous 1 2 … 13 14 15 16 17 … 82 83 Next » Question and answer is powered by anspress.net
