Complete guidance documents for pharmaceutical production process

Drug production process is a process and method to produce qualified drugs continuously and stably The premise of ensuring drug quality is to organize production according to the production process approved by the regulatory authorities In order to strengthen the management of drug production process, CFDA issued the announcement on carrying out the verification of drug production process (Draft for comments) (hereinafter referred to as the announcement) on August 11 The announcement set off another big shock in the pharmaceutical industry The consistency evaluation of generic drugs, which has made countless enterprises cry, is only aimed at chemical drugs, while the production process verification is aimed at all drugs Whether it is traditional Chinese medicine, chemical medicine, biological medicine, imported or domestic, it is necessary to carry out self inspection of production process and flight inspection of the State Food and drug administration, which has a huge impact "Self inspection + flight inspection" is like a blade hanging on the head of pharmaceutical enterprises Many small and medium-sized enterprises are facing the crisis of production suspension, and the industry reshuffle may intensify The announcement clearly points out the following three points: first, the content of self inspection is whether the actual production process of drugs is consistent with the production process approved by the food and drug regulatory authorities If there is any inconsistency, the enterprise shall immediately stop production if the change of production process has an impact on the quality of drugs after research and verification; secondly, the manufacturer shall complete the self inspection and report the self inspection to the local provincial food and drug regulatory department before October 1, 2016; thirdly, from November 1, 2016, the State Food and Drug Administration will organize experts to carry out flight inspection on the drug production enterprises 。 The form is severe, the check of production process is inevitable, and mastering more information may increase the first-line hope The key words of "production process" are input by the author through the drug intelligence policy and Regulations Database (http://db.yaozh.com/policies), and the retrieval results include the information about drug production process from the State Drug Administration, drug Audit Center, CDE electronic publication, ICH and FDA for your reference Click the title to view the full text: the release date of the regulatory title; the general office of the General Administration of the State Food and Drug Administration's public consultation on the announcement on the implementation of the verification of drug production process (Draft for comments); August 11, 2016; issues to be concerned in the preparation of new Chinese medicine production process for on-site inspection; Zhou Gang CDE electronic publication 2014 Notice on production process change of imported biological products in accordance with Chinese Pharmacopoeia (2010 Edition) key points of production process of virus inactivated vaccine by State Food and Drug Administration on May 26, 2011 Notice on printing and distributing seven technical guidelines for safety re evaluation of production process of traditional Chinese medicine injection 2010.09.29 of the State Food and Drug Administration opinions on issues related to production process and prescription verification of essential drugs 2010.09.01 of the State Food and Drug Administration Technical guidelines for change management of production process of biological products by State Food and Drug Administration on November 24, 2008 National Drug Evaluation Center (CDE) on the requirements of production process content in registration approval document on September 4, 2008 Biological indicator CDE electronic publication in aseptic production process validation 2007.11.21 notice on carrying out injection drug production process and prescription verification 2007.08.10 state food and Drug Administration on how to ensure the consistency of application process and mass production process CDE electronic publication 2007.07.12 compatibility of biological / biological products subject to Changes in the manufacturing process (comparability of biotechnology products / biological products after the change of production process) International Coordinating Committee for human drug registration technical requirements (ICH) November 18, 2004 what standards and production processes should drugs be produced according to? What are the requirements for production records? Food and Drug Administration (FDA) 1987.02.01 note: This article is the original of the author of yaozhi.com, welcome to reprint, please indicate the source and author when reprint, thank you!