欧盟GMP指南中文版.pdfVIP

QbR Frequently Asked Questions Disclaimer: These are general answers and may not be applicable to every product. Each ANDA is reviewed individually. This document represents the Office of Generic Drugs’s (OGD’s) current thinking on these topics. Format and Submission How should QbR ANDAs be submitted? OGD’s QbR was designed with the expectation that ANDA applications would be organized according to the Common Technical Document (CTD) format, a submission format adopted by multiple regulatory bodies including FDA. Generic firms are strongly recommended to submit their ANDAs in the CTD format (either eCTD or paper) to facilitate implementation of the QbR. The ANDA Checklist for completeness and acceptability of an application for filing can be found on the OGD web page: /cder/ogd/anda_checklist.pdf . What is a QOS? The Quality Overall Summary (QOS) is the part of the CTD format that provides a summary of the CMC aspects of the application. It is an important tool to make the QbR review process more efficient. How long should a QOS be? OGD believes the CTD guidance1 recommendation of 40 pages to be an appropriate compromise between level of detail and concision. The CTD guidance recommendation does not include tables and figures. The same information should not be included in multiple locations in the QOS. Instead of repeating information, refer to the first location of the original information in the QOS by CTD section number. Should the QOS be submitted electronically? All applications should include an electronic QOS. For paper submissions, it is recommended that both an electronic QOS and a paper QOS be included. What file format should be used for the QOS? All applications, both eCTD and paper submissions, should have an electronic QOS. The electronic QOS should be