Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans If an API is manufactured by a contractor and not yet released by their QA, can this be shipped by the contractor, to the original company with the intention of then shipping on to another contractor for manufacturing the drug product? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the quality unit have to be the point of contact for a complaint with the contract manufacturer? Can the production person be the gatekeeper for that? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you expand on the requirement that contract manufacturer should permit a company to audit its contractor facility? What recourse does a company have when the contract manufacturer is not allowing audits? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans If a contract manufacturer needs to change the raw material supplier, may the contract manufacturer make the change and simply notify the contract giver? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans In the situation where the contract giver officially releases the API, is it acceptable to delegate review of batch records to the contract acceptor? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans If I understood well, the Haiti incident, the problem was caused by a raw material, how does Section 17 prevent this from reoccurring? Should the requirements be part of the material section? 1.23K viewsDrugsPharmaceutical 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? 1.23K 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? 1.40K 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? 1.29K 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? 1.26K 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? 1.32K 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? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an API manufacturer responsible for insuring compliance of his agents that purchase material from the API manufacturer? 1.24K 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? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Staying with out favorite subject, does this section apply to customs brokers and shippers? The definition seems to apply. 1.34K 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 « Previous 1 2 … 58 59 60 61 62 … 82 83 Next » Question and answer is powered by anspress.net
