Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Does training record maintenance differ significantly from what is specified by 211? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Are regulators looking for disciplinary action against basic GMP errors made by trained and qualified operators? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Does the fact that training should be periodically assessed mean testing of individuals or watching the individual perform the operation? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Please expand on the definition of consultant. Can we exclude persons who are contractors that work under direct supervision of company employees? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Please give an example of what qualified means to a laboratory technician. Is it ten years experience? Is it a BS in chemistry? Is it documented training on certain LC and GC analysis or is it some sort of combination of all of that? 1.75K viewsDrugsPharmaceutical 0 Votes 1 Ans Please clarify the meaning of “training should be periodically assessed”. Does this mean competency assessment of those being trained, i.e. post-training assessment? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans If the laboratory is part of the quality unit, Then the procedures, test methods, equipment, etc., must be approved by the quality unit in addition to the person in the laboratory? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans In the non-delegateable activities, does that mean that I cannot have a quality control laboratory as an external supplier? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Do the responsibilities not to be delegated by QA apply to both clinical and commercial APIs? For example, do manufacturing instructions require QA approval prior to commencement of the manufacturing step? 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans What should approving of contract manufacturers involve? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans You mention the audit expectation for API starting material suppliers. What do you expect from audits of API suppliers by drug product manufacturers? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there no need for environmental monitoring such as occupational hygiene monitoring for API manufacturing? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Please further clarify the scope of QA and the approval of master production instructions versus the production review and approval. 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Q7A says the quality unit should review and approve all appropriate quality related documents. How much scope did the expert group give to this statement? It’s easy to see why production and laboratory documents, but what about maintenance documents? Should the quality unit review and approve a procedure that, for example, tells a mechanic how to put oil into a pump? Another example, should they approve housekeeping procedures? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it ever appropriate for the quality unit to make sure that the Product Quality Review is performed by another group or is this an activity not to be delegated? For example, review of in process controls, critical API results performed by protocol, approved by the quality unit, issued from technical operations, a group that does not report directly to the quality unit. 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans What is expected with regard to trending deviations? 1.82K viewsDrugsPharmaceutical 0 Votes 1 Ans Would it be acceptable to use annual product review as an opportunity to determine which processes and products require revalidation? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans Under Section 2.5, the product quality review, what is the expectation for the review of critical in process control and critical API test results? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans Similarly, what is expected in the product quality review for the review of the accuracy of the corrective actions? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans How are the FDA investigators actually receiving your advice and what are we doing to provide specific training? 1.52K viewsDrugsPharmaceutical « Previous 1 2 … 75 76 77 78 79 80 Next » Question and answer is powered by anspress.net
