Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Since most APIs are manufactured outside the US (80 percent or so), and the FDA’s moving to the MRA for inspections, what training is being given to government inspectors outside the US, and what about FDA foreign inspection teams? 2.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Just confirming, the definition of “should” could vary from country to country in the final version, for instance the US FDA versus the EU version. What would you recommend for companies that are international/global? Another person also wanted some practical, down-to-earth words around what “should” should mean. In other words, in here, the person asks, is “should” in ICH similar to “must”, is “should” in FDA similar to “good to do”? In other words, I think there’s a little confusion around “should”. 1.89K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the main differences between the FDA’s March 1998 API draft and Q7A? 1.91K viewsDrugsPharmaceutical 0 Votes 1 Ans FDA plans to revise its September 1991 guide to inspection about pharmaceutical chemicals and why the need to revise? Does Q7A not replace the 1991 guide? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans What does Q7A mean? 1.83K viewsDrugsPharmaceutical 0 Votes 1 Ans USP requires water used in the manufacture of parenterals to be water for injection, WFI. Does Q7A conflict with this? 1.80K 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? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans The new ICH guideline is a major step forward in ensuring the quality of APIs. How does the FDA plan to ensure that they are applied and interpreted consistently by field investigators, and who, when, and how it will be applied to overseas suppliers? Additionally, it is really encouraging to see the support and participation of FDA in this important series of workshops. How does the Agency plan to carry through this commitment within its own organization, for example, training of field staff, key review personnel in the application of Q7A to API manufacturing? 1.70K 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. 1.90K 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? 1.90K 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. 1.85K viewsDrugsPharmaceutical 0 Votes 1 Ans Did the Expert Working Group discuss a definition of timely? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans If equipment is closed, do you usually need environmental controls? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A apply to excipients manufacturer? 1.75K 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? 1.89K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you define a “significant structural element” in an API starting material? 1.64K viewsDrugsPharmaceutical 0 Votes 1 Ans How close can you get to the API and still call it an API starting material? 1.86K 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? 1.78K viewsDrugsPharmaceutical 0 Votes 1 Ans If you identify an API starting material vendor, does that vendor need to be audited or qualified? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Are internal audit reports mentioned in Section 2.4 subject to FDA review during an inspection? 1.80K viewsDrugsPharmaceutical « Previous 1 2 … 77 78 79 80 81 82 83 Next » Question and answer is powered by anspress.net
