Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans If equipment is closed, do you usually need environmental controls? 1.41K viewsDrugsPharmaceutical 0 Votes 1 Ans When and where do we start applying CGMPs? For example, we may use isopropanol to make the reaction of our API or to purify API. We do not manufacture isopropanol, so does the manufacturer of isopropanol have to follow all the CGMPs that apply to us? Does the manufacturer of any excipient have to follow the CGMPs as we do? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Does Q7A apply to excipients manufacturer? 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? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans I’ve got a question here about critical deviation and non-conformity or nonconformance and why were these not harmonized in the document? 1.38K 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. 1.40K 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? 1.63K 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? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there any guidance requirements within Q7A for starting materials? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans To my knowledge, China, Australia, and India have not had official (observer or participant) status in previous ICH guidance processes. By participating in Q7A, do they agree to be bound by it? 1.58K viewsDrugsPharmaceutical 0 Votes 1 Ans As a clarification to this question, will the Indian and Chinese regulators be enforcing Q7A on their domestic manufacturers? 1.40K 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? 1.58K 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”. 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the main differences between the FDA’s March 1998 API draft and Q7A? 1.66K 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? 1.56K 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? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans What does Q7A mean? 1.54K viewsDrugsPharmaceutical 0 Votes 1 Ans USP requires water used in the manufacture of parenterals to be water for injection, WFI. Does Q7A conflict with this? 1.50K viewsDrugsPharmaceutical 0 Votes 1 Ans Now that we have Quality System Inspections and Q7A, can you describe what you envision as a typical FDA inspection of an API plant? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans Any background, history on why the accountability for lab records was not included in Q7A? For example, numbered pages in a lab bound notebook or sequential lab sheets that cannot be duplicated. 1.61K viewsDrugsPharmaceutical « Previous 1 2 … 10 11 12 13 14 … 79 80 Next » Question and answer is powered by anspress.net
