Maya，Manager, Qilu Pharmacy Group Company Shandong Anxin Pharmaceutcal Co., Ltd.

Topic: EU GMP Annex 1: The New Draft and the Implications for Sterile Products Manufacturing

Speaker Bio

Qu Manhong, Senior Engineer and licensed pharmacist, graduated from Shandong Medical University (now Shandong University), majoring in pharmacy. Now working in the Pharmacovigilance Department of Shandong Anxin Pharmaceutical Co., LTD., Qilu Pharmaceutical Group. Before that, Qu Manhong was in charge of supplier management department, Quality assurance Department, preparation park quality management Department and other production quality management of Qilu Pharmaceutical Co., LTD. During more than 20 years’ management of pharmaceutical production quality and the experience of working with domestic and foreign official audits, Qu Manhong is familiar with the requirements and technical guidelines for drugs of GMP of Europe, America, China, Japan and other countries, and has rich experience in pharmaceutical production quality management and supplier management; Qu manhong has audit on hundreds of suppliers of raw materials, packaging materials, and pharmaceutical intermediates, and assist supplier to improve production management level, ensuring the safety of production materials. As a trainer, Qu Manhong have made many speeches at the invitation of National Biological Industry Conference, PDI, CPAPE, and China Pharmaceutical Auxiliary Materials Development Alliance, etc.

Presentation Summary

The first appendix of the European Medicines Regulation (EudraLex), which forms part of volume IV of the European Guide, covers the manufacture and release of sterile products subject to specific requirements. The review process began with a draft released in December 2017. The draft received more than 6000 submissions from professional organizations. After two years of review, the European Medicines Agency (EMA) has published a new draft. The new draft addresses some of the issues in the first edition and contains some other requirements. The consultation on July 20, 2020 has ended. The main content of this speech is the overview and structure of the draft, revision trigger points and key changes, etc., and the analysis of the impact of the new draft on sterile products.