Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 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? 1.55K 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? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the FDA doing to ensure the safety of drugs coming from Japan? 1.69K 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? 1.44K viewsPharmaceutical 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? 1.74K 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? 1.78K viewsPharmaceutical 0 Votes 1 Ans Can Total Organic Carbon (TOC) be an acceptable method for detecting residues of contaminants in evaluating cleaning effectiveness? 1.37K 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? 1.47K 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? 1.62K 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? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans For drug products formulated with preservatives to inhibit microbial growth, is it necessary to test for preservatives as part of batch release and stability testing? 1.46K viewsPharmaceutical 0 Votes 1 Ans What are the benefits of implementing a pharmaceutical quality system (PQS) (in accordance with ICH Q10)? 1.57K viewsPharmaceutical 0 Votes 1 Ans How will system-related inspections differ in an ICH Q8, Q9, and Q10 environment? 1.65K viewsPharmaceutical 0 Votes 1 Ans Why is FDA concerned about drug contamination with halogenated anisole compounds, such as 2,4,6-tribromoanisole (TBA)? 1.71K viewsPharmaceutical 0 Votes 1 Ans Has FDA identified the source of the halogenated anisole compounds that have contaminated drug products? 1.65K viewsPharmaceutical 0 Votes 1 Ans Many leading analytical balance manufacturers provide built-in “auto-calibration” features in their balances. Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be? 1.70K 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? 1.58K 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? 1.70K viewsPharmaceutical 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? 1.70K viewsPharmaceutical 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? 987 viewsPharmaceutical « Previous 1 2 … 79 80 81 82 83 Next » Question and answer is powered by anspress.net
