Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans If an API is supplied from one location to another within the same company for manufacture of dosage form at the other location and quality complaints are received from the dosage form manufacturing location, are these considered complaints as defined in Q7A? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans In Q7A it states that all quality related complaints be recorded. Is there an expectation to record and investigate non-quality related complaints? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you think a recall procedure is really needed at the API manufacturer considering that it will be the API customer accepting or rejecting that API, and in case of rejection, sending the material back to the manufacturer? The real recall will be in charge of the pharma transformer that will put the drug product into the market. 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans When would a retest date be used as opposed to an expiry date? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there an expected function from marketing or senior management in responding to complaints or recalls according to Q7A? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans The first bullet point in Section 15 deals with quality related complaints. What about non-quality related complaints? Do they have to be investigated? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you define examples of quality-related complaints? Are they “out of spec” issues only, or what other examples fall under this heading? 1.19K viewsDrugsPharmaceutical 0 Votes 1 Ans Will the FDA inspect the ABTDR to ensure compliance with GMPs? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans What you suggest in Section 17 may be appropriate, but how can we appropriately regulate nations that seem to freely operate outside the sphere of accepted regulatory practice? Can it truly be effective or is it easily circumvented? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you know if an agent is authorized? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Why did Q7A not include a requirement to have a written contract that covers GMP responsibilities? 1.31K 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? 1.22K 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? 1.32K 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. 1.32K 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? 1.13K 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? 1.21K 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? 1.27K 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? 1.24K 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? 1.24K viewsDrugsPharmaceutical « Previous 1 2 … 57 58 59 60 61 … 79 80 Next » Question and answer is powered by anspress.net
