Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Are regulators looking for disciplinary action against basic GMP errors made by trained and qualified operators? 1.59K 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? 1.63K 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? 1.49K 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? 1.38K viewsDrugsPharmaceutical 0 Votes 1 Ans What should approving of contract manufacturers involve? 1.61K 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? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans Equipment and computerized systems are not part of the term material, so suppliers of critical equipment and computerized systems do not need to be approved. 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Typically an API manufacturer performs quality tests on intermediates. If it passes, then QC will release the intermediate for the next synthesis step. The quality unit then reviews the entire batch records at the end and releases the final API. It seems that Q7A requires that the quality unit review the batch records and test results at each step, prior to moving to the next step. This may not be practical in some cases. 1.76K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there no need for environmental monitoring such as occupational hygiene monitoring for API manufacturing? 1.71K 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. 1.33K 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? 1.50K 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. 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans What is expected with regard to trending deviations? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans Radiopharmaceuticals. Are APIs involved in radiopharmaceutical production? Are radiopharmaceuticals excluded from the scope of Q7A because of their unusual process? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Can an investigator issue observations based on the Q7A guidance? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Would the acid used to convert a free base into a salt form of a drug substance be considered an API starting material? Significant structural fragment? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans What is your opinion regarding API manufactured with limited resources in which the quality unit if comprised of only one person? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans “Independent from production”. Does having different managers constitute independence? If not, at what point in an organization is it acceptable for quality and manufacturing to report to the same person? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Should quality units actually develop definitions and examples of deviations and critical deviations? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Why should rejection of an API not be delegated? In other words, does manufacturing have the right to reject if something goes out of specification? 1.80K viewsDrugsPharmaceutical « Previous 1 2 … 9 10 11 12 13 … 82 83 Next » Question and answer is powered by anspress.net
