Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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 0 Votes 1 Ans Release authority for intermediates can be delegated to production except for intermediates that are sold, what about intermediates that are shipped within companies within the same corporation? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans If the laboratory is part of the quality unit, must the procedures, test methods, equipment, etc., be approved by the quality unit in addition to the person in the laboratory? 1.68K 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? 1.73K viewsDrugsPharmaceutical 0 Votes 1 Ans If the raw material is commercially available, and if this raw material is the API only after purification, so we’re basically one step removed, does the raw material manufacturer fall under Q7A? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans If the Act does not make a distinction between API and dosage drug product and 21 CFR 211 is a regulation and ICH Q7A is a guidance document, then an FDA investigator may still choose to inspect an API manufacturer using specifically and only 21 CFR 211. 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Did the Expert Working Group discuss a definition of timely? 1.58K viewsDrugsPharmaceutical « Previous 1 2 … 9 10 11 12 13 … 79 80 Next » Question and answer is powered by anspress.net
