Pharmaceutical Pharmaceutical 1645 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What is expected with regard to trending deviations? 1.73K 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 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? 1.47K 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 Why critical deviation and nonconformity or nonconformance are not harmonized in the document? 1.44K 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 Radiopharmaceuticals. Are APIs involved in radiopharmaceutical production? Are radiopharmaceuticals excluded from the scope of Q7A because of their unusual process? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans Can an investigator issue observations based on the Q7A guidance? 1.29K 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? Signify structural fragment? 1.63K 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? 1.52K 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? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Should quality units actually develop definitions and examples of deviations and critical deviations? 1.46K 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? 1.70K 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? 1.40K viewsDrugsPharmaceutical 0 Votes 1 Ans As a clarification to this question, will the Indian and Chinese regulators be enforcing Q7A on their domestic manufacturers? 1.67K viewsDrugsPharmaceutical « Previous 1 2 … 76 77 78 79 80 … 82 83 Next » Question and answer is powered by anspress.net
