Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 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? 1.69K 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 0 Votes 1 Ans Since most APIs are manufactured outside the US (80 percent or so), and the FDA’s moving to the MRA for inspections, what training is being given to government inspectors outside the US, and what about FDA foreign inspection teams? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the main differences between the FDA’s March 1998 API draft and Q7A? 1.71K viewsDrugsPharmaceutical 0 Votes 1 Ans Just confirming, the definition of “should” could vary from country to country in the final version, for instance the US FDA versus the EU version. What would you recommend for companies that are international/global? Another person also wanted some practical, down-to-earth words around what “should” should mean. In other words, in here, the person asks, is “should” in ICH similar to “must”, is “should” in FDA similar to “good to do”? In other words, I think there’s a little confusion around “should”. 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans The new ICH guideline is a major step forward in ensuring the quality of APIs. How does the FDA plan to ensure that they are applied and interpreted consistently by field investigators, and who, when, and how it will be applied to overseas suppliers? Additionally, it is really encouraging to see the support and participation of FDA in this important series of workshops. How does the Agency plan to carry through this commitment within its own organization, for example, training of field staff, key review personnel in the application of Q7A to API manufacturing? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans FDA plans to revise its September 1991 guide to inspection about pharmaceutical chemicals and why the need to revise? Does Q7A not replace the 1991 guide? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans What does Q7A mean? 1.65K viewsDrugsPharmaceutical « Previous 1 2 … 76 77 78 79 80 Next » Question and answer is powered by anspress.net
