Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What criteria does FDA use for selecting foreign food facilities for inspection? 1.41K viewsFood Safety 0 Votes 1 Ans What is FDA’s focus while conducting a routine surveillance inspection? 1.74K viewsFDA 0 Votes 1 Ans What prompted development of the Concept of Operations (ConOps)? 1.51K viewsFDA 0 Votes 1 Ans How does FDA communicate the final inspection classification? 1.58K viewsFDA 0 Votes 1 Ans Is the agency updating internal policies and procedural documents to reflect the ConOps? 1.61K viewsFDA 0 Votes 1 Ans Will the ConOps help address problems at manufacturing facilities that have impacted approval of drug applications? 1.67K viewsFDA 0 Votes 1 Ans Is there a list of CDER-approved drug manufacturing equipment? 1.59K viewsFDA 0 Votes 1 Ans Does FDA prefer one type of material over another (e.g., polyvinylidene difluoride over stainless steel) for construction of recirculating loops in water for injection (WFI) systems? 1.32K viewsFDA 0 Votes 1 Ans What does an FDA investigator do upon completing an inspection? 1.72K viewsFDA 0 Votes 1 Ans Does FDA expect firms to investigate both released and rejected lots for potential recalls? 1.66K viewsFDA 0 Votes 1 Ans How do the Part 11 regulations and “predicate rule requirements” (in 21 CFR Part 211) apply to the electronic records created by computerized laboratory systems and the associated printed chromatograms that are used in drug manufacturing and testing? 1.49K viewsFDA 0 Votes 1 Ans How does the FDA interpret the regulations (21 CFR Part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents? 1.48K viewsFDA 0 Votes 1 Ans What if the improper storage conditions include exposure to toxic fumes or radiation? 1.73K viewsFDA 0 Votes 1 Ans How can consumers identify products that may be violative? 1.64K viewsFDA 0 Votes 1 Ans Is it possible to obtain an exemption from specific provisions of the GLPs for special nonclinical laboratory studies? 1.58K viewsFDA 0 Votes 1 Ans Under what conditions can quality typically delegate authority for releasing Intermediates to production? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans What’s the minimum amount of information required for the labels on containers of starting materials when they are received prior to API manufacturing? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the FDA have any objection to storage and shipment of APIs in polyethylene lined fiber drums? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans 9.2 states that containers should not be additive beyond the specified limits. This imputes the need to evaluate packaging for interaction with the API. On the other hand, that additive of packaging implied is not a concern so long as the API is not altered beyond its specification. Please clarify how an API manufacturer might justify not evaluation product/packaging interactions. 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans What kind of ID test is acceptable for packaging materials, such as polyethylene bags, lined drums? Is the shipping document of packaged material used in lieu of a C-of-A? 1.80K viewsDrugsPharmaceutical « Previous 1 2 … 46 47 48 49 50 … 283 284 Next » Question and answer is powered by anspress.net
