Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans We are a generic pharmaceutical manufacturer and we use APIs. Most APIs are purchased through vendors, and the questioner actually mentions a couple companies, some purchased directly from manufactures. Are these vendors considered agents and are they bound to Section 17 even though we are drug product manufacturers? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is going to monitor that agents comply with GMP regulations? Are health authorities like FDA involved or is this part of the purchaser or manufacturers’ responsibilities just as it is now with suppliers of raw materials or contract manufacturers? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it okay to state that the company has audited the supplier and therefore full analysis of a lot is not required? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Will the FDA audit agents for compliance in Q7A? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans How is Section 17…enforceable when Q7A is a guidance document? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 17 very explicitly, in the opening paragraph, says that it applies to APIs or intermediates. Is that written for raw materials? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Could you comment on the responsibilities of an agent as opposed to a contract manufacturer? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans If an agent or user of an API requests a retest date extension, can the API manufacturer based upon analysis stability samples retained by the manufacturer provide the extension? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an API manufacturer responsible for insuring compliance of his agents that purchase material from the API manufacturer? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Given the high level of concern over the Haitian incident, why doesn’t Q7A require approval of incoming materials prior to use rather than allow use when systems are in place prior to completion of testing? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Staying with out favorite subject, does this section apply to customs brokers and shippers? The definition seems to apply. 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans I believe that most at this meeting would agree that it would a mistake for a body to attempt to write guidelines for the API industry without having representatives from the API industry involved. Other than the ability to provide comments on step two, did the industry participate in writing of Section 17? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Why was Section 17.5 included? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Can all starting materials be considered equal? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Adenoviruses. Are they considered whole cell and thus excluded from Q7A? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Please provide some examples of blood or plasma as a raw material where Q7A applies versus blood derivatives where Q7A does not apply? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans If an API is extracted for a mammalian tissue, does Q7A apply? At what stage? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans A biotech intermediate is chemically modified. This modification is maintained throughout the API and drug product. A biotech intermediate is chemically modified, but this modification is removed prior to the completion of the API. Is either or both of the chemicals used for the modification considered an API starting material? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it anticipated that these products would eventually be covered by this guideline? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans Why are human plasma-derived protein products specifically excluded from the Q7 guidelines? 1.25K viewsDrugsPharmaceutical « Previous 1 2 … 58 59 60 61 62 … 79 80 Next » Question and answer is powered by anspress.net
