Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Do manufacturers of OTC products have to report quality defects? 1.57K 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? 1.76K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the CGMP regulations permit the destruction of an internal quality assurance audit report once the corrective action has been completed? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans What should a firm do if its drug products or components have been subjected to improper storage conditions such as those caused by a natural disaster? 1.76K viewsDrugsPharmaceutical 0 Votes 1 Ans What should be considered in performing an assessment of whether a firm’s drug product, or its components or packaging materials may have been contaminated with radioactive material? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the FDA doing to ensure the safety of drugs coming from Japan? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans Auditing Systems for 21 CFR Part 11-Validation of Software Programs – We have a GcP app on a server. When we need to install some additional utility apps and supporting app on that server such as Adobe Reader, Word and Firefox, do we need to qualify or validate these software programs? 1.50K viewsFDA 0 Votes 1 Ans What would the FDA think about test documents with actual results typed in instead of being handwritten? 1.88K viewsHuman Resources 0 Votes 1 Ans What do you think might be the biggest difference between the requirements of FDA’s device requirements and the EU’s MDR? 1.60K viewsMedical Device 0 Votes 1 Ans What are some of the biggest changes in the new regulations that will impact device manufacturers? 1.74K viewsMedical Device 0 Votes 1 Ans What are FDA’s concerns about the use of raw manure as fertilizer in crop production? 1.86K viewsFDA 0 Votes 1 Ans What research has FDA already done into the survival of pathogens, such as E. coli O157:H7, in soil amended with raw manure? 1.88K viewsFDA 0 Votes 1 Ans What is the Medical Device Single Audit Program? 1.47K viewsMedical Device 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? 1.79K 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? 1.84K viewsPharmaceutical 0 Votes 1 Ans Can Total Organic Carbon (TOC) be an acceptable method for detecting residues of contaminants in evaluating cleaning effectiveness? 1.43K viewsPharmaceutical 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? 1.54K viewsPharmaceutical 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? 1.68K viewsPharmaceutical 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? 1.70K 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 viewsPharmaceutical « Previous 1 2 … 277 278 279 280 281 … 283 284 Next » Question and answer is powered by anspress.net
