Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Why did Q7A not include a requirement to have a written contract that covers GMP responsibilities? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Who would have the right or the responsibility to audit or assure GMPs are adequate at the repackaging or relabeling company? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an agent who imports or sells an API without doing any other operation responsible for determining the GMP status of the overseas manufacturer? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Given these new requirements for agents, who will enforce these? The API manufacturer may not even know his product is being repacked and redistributed, so the API manufacturer cannot police. Is the burden then on the finished product manufacturer who purchases this? If the repacker is clever, and they are, you may never know. Will the FDA be more active in this area? Many of these distributors don’t even register with the FDA. 1.26K viewsDrugsPharmaceutical 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? 1.07K 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? 1.17K 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? 1.13K 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? 1.20K 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? 1.17K 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? 1.19K 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? 1.19K 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? 1.35K 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? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Will the FDA audit agents for compliance in Q7A? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans How is Section 17…enforceable when Q7A is a guidance document? 1.23K 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? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans Could you comment on the responsibilities of an agent as opposed to a contract manufacturer? 1.20K 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? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Is an API manufacturer responsible for insuring compliance of his agents that purchase material from the API manufacturer? 1.21K 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? 1.38K viewsDrugsPharmaceutical « Previous 1 2 … 239 240 241 242 243 … 283 284 Next » Question and answer is powered by anspress.net
