Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Can an investigator issue observations based on the Q7A guidance? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Would the acid used to convert a free base into a salt form of a drug substance be considered an API starting material? Signify structural fragment? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans What is your opinion regarding API manufactured with limited resources in which the quality unit if comprised of only one person? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans “Independent from production” Does having different managers constitute independence? If not, at what point in an organization is it acceptable for quality and manufacturing to report to the same person? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Should quality units actually develop definitions and examples of deviations and critical deviations? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Why should rejection of an API not be delegated? In other words, does manufacturing have the right to reject if something goes out of specification? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Release authority for intermediates can be delegated to production except for intermediates that are sold, what about intermediates that are shipped within companies within the same corporation? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans As a clarification to this question, will the Indian and Chinese regulators be enforcing Q7A on their domestic manufacturers? 1.67K viewsDrugsPharmaceutical 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? 1.80K 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”. 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the main differences between the FDA’s March 1998 API draft and Q7A? 1.71K 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? 1.51K 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? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans What does Q7A mean? 1.65K 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? 1.60K 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 « Previous 1 2 … 273 274 275 276 277 … 283 284 Next » Question and answer is powered by anspress.net
