Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans If prior to the finished purification we add to the batch second crops from previous batches or residues from the dryer process of a previous batch, is it not blending? Is it reprocessing? So are we allowed to do this type of reprocessing? 908 viewsDrugsPharmaceutical 0 Votes 1 Ans Does material reprocessed by the filed process get a new manufacturing date under Q7A? There is a school of thought that understands original manufacturing date must be kept. 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Reference standards are extensively characterized in house. When we send these standards to our contract manufacturer, what tests should they conduct on the material received? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Under QA responsibilities not to be delegated, approval of contract manufacturers was listed. The question is, what does this mean? What specific responsibilities does QA have to approve a contract manufacturer? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans For contract manufacturing, is an audit required if the firm has on-site representatives during all the manufacturing at the contractor’s site? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it all right to use contract warehouse space for storage of APIs? 1.23K viewsDrugsPharmaceutical 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? 1.21K 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? 1.21K 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. 930 viewsDrugsPharmaceutical 0 Votes 1 Ans When would a retest date be used as opposed to an expiry date? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there an expected function from marketing or senior management in responding to complaints or recalls according to Q7A? 1.35K 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? 1.08K 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? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Will the FDA inspect the ABTDR to ensure compliance with GMPs? 1.05K 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? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you know if an agent is authorized? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Why did Q7A not include a requirement to have a written contract that covers GMP responsibilities? 1.20K 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? 1.14K 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. 1.25K viewsDrugsPharmaceutical « Previous 1 2 … 57 58 59 60 61 … 82 83 Next » Question and answer is powered by anspress.net
