2013 Certificate of Analysis Guide for …（2013证书的分析指导u2026）.pdfVIP

2013 Certificate of Analysis Guide for Pharmaceutical Excipients June 25, 2014 Amsterdam, The Netherlands Karine ROTH, Novartis Pharma AG IPEC Europe Board Member General Statement This presentation is based on publicly available information; These slides are intended for educational purposes only and for the personal use of the audience. These slides are not intended for wider distribution outside the intended purpose without presenter approval; The content of this slide deck is accurate to the best of the presenter’s knowledge at the time of production; The views and opinions expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of Novartis or any of its officers 2 AGENDA Purpose of Certificate Of Analysis Guide (COA) Design and Required Elements of a COA • Requirements • Examples Establishing Dates of COA Reporting of Data Use of Electronically Generated COA Distributor Information 3 Purpose of Certificate Of Analysis Guide (COA) The Certificate Of Analysis (COA) is a critical element of the overall supply chain controls needed to provide the user with assurance of excipient conformance to specification and its suitability for use in pharmaceuticals. 4 Purpose of Certificate Of Analysis Guide (COA) The COA is a legal document that certifies the quality of the excipient and demonstrates that the batch conforms to the defined specifications, has been manufactured under excipient GMP, and is suitable for use in pharmaceuticals. A COA for excipients should be prepared and issued by the company responsible for the material. When analysis is performed by a distributor, the distributor should issue a COA to the user for any analysis performed by or on behalf of the 5 distributor. Purpose of Certificate Of Analysi