Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 1.50K 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? 1.42K 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? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans What should approving of contract manufacturers involve? 1.47K 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? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there no need for environmental monitoring such as occupational hygiene monitoring for API manufacturing? 1.58K 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. 1.50K 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? 1.48K 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. 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans What is expected with regard to trending deviations? 1.74K 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? 1.65K 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? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Similarly, what is expected in the product quality review for the review of the accuracy of the corrective actions? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans How are the FDA investigators actually receiving your advice and what are we doing to provide specific training? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans When can we expect the industrial guidelines that went into the development of Q7A to be integrated into the local regulatory agencies. For example, as part of the CFR requirements that would insure compliance. 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans The FDA version of ICH Q7A. Why did the FDA version format the section numbers or leave out the section numbers? 1.49K viewsDrugsPharmaceutical 0 Votes 1 Ans If GMP does not start until the starting material is used in the manufacture of APIs, why then are starting material manufacturers inspected for GMPs? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any guidance requirements within Q7A for starting materials? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans Why critical deviation and nonconformity or nonconformance are not harmonized in the document? 1.44K 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? 1.47K viewsDrugsPharmaceutical « Previous 1 2 … 272 273 274 275 276 … 283 284 Next » Question and answer is powered by anspress.net
