Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans USP requires water used in the manufacture of parenterals to be water for injection, WFI. Does Q7A conflict with this? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Now that we have Quality System Inspections and Q7A, can you describe what you envision as a typical FDA inspection of an API plant? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Any background, history on why the accountability for lab records was not included in Q7A? For example, numbered pages in a lab bound notebook or sequential lab sheets that cannot be duplicated. 1.69K viewsDrugsPharmaceutical 0 Votes 1 Ans If the raw material is commercially available, and if this raw material is the API only after purification, so we’re basically one step removed, does the raw material manufacturer fall under Q7A? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans If the Act does not make a distinction between API and dosage drug product and 21 CFR 211 is a regulation and ICH Q7A is a guidance document, then should a FDA investigator may still choose to inspect an API manufacturer using specifically and only 21 CFR 211. 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Did the Expert Working Group discuss a definition of timely? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans If equipment is closed, do you usually need environmental controls? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A apply to excipients manufacturer? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Based on FDA changing of the meaning of “should”, does this mean that Q7A will be applied differently in the US than in the EU? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you define a “significant structural element” in an API starting material? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans How close can you get to the API and still call it an API starting material? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans How early should a company discuss with FDA the company strategy, rationale and what we consider to be an API starting material for filing? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans If you identify an API starting material vendor, does that vendor need to be audited or qualified? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans Are internal audit reports mentioned in Section 2.4 subject to FDA review during an inspection? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Concerning the distinction that you made between ICH versus VICH for APIs for veterinary products, which standards do the FDA inspectors use in the plants producing APIs for US vet products? Are there any differences seen during a PAI, and which standards should a plant follow? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans You said that the WHO has now decided to compare the Q7A document with its 1992 API GMPs., I heard previously that the WHO was adopting Q7A with no mention of this evaluation. Is this just a standard procedural issue at WHO or do they have specific concerns, doubts, problems with Q7A? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans To my knowledge, China, Australia, and India have not had official (observer or participant) status in previous ICH guidance processes. By participating in Q7A, do they agree to be bound by it? 1.53K viewsDrugsPharmaceutical 0 Votes 1 Ans Has FDA established guidelines for the frequency of calibration of equipment (balances) used in nonclinical laboratory studies? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Have U.S. manufacturers of potassium iodide been asked to ship any products to Japan? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Can a sponsor of an investigational new drug export its product to Japan? Does FDA have to authorize such an export? 1.66K viewsDrugsPharmaceutical « Previous 1 2 … 77 78 79 80 Next » Question and answer is powered by anspress.net
