EU revised GMP annex 15

Source: on March 34, 2014, the European Union released the revised draft of annex 15 "validation and validation" of GMP This appendix specifies the principles for the validation and validation of facilities, equipment, public systems and processes applicable to drug production The draft requires manufacturers to control key elements through validation and validation covering the life cycle of products and processes Any changes that may have an impact on product quality should be formally documented and the impact on verification status or control strategy should be evaluated The appendix emphasizes in the overview that the quality risk management method should be applied to the whole life cycle of drugs The confirmation and validation scope shall be determined based on reasonable risk assessment and documented Ichq8, Q9, Q10, Q11 or other principles to ensure product quality and safety shall be used to support verification and validation activities Compared with the previous edition, this appendix has changed a lot Transportation confirmation, packaging verification, public system verification and inspection method verification are added In addition, it is particularly worth mentioning that the process validation draws on the concept of FDA of the United States, and the validation content and concept have changed substantially, including the initial validation of new process, process change validation, site transfer and continuous process validation The draft appendix is for public comment until May The revised appendix 15 is expected to take effect in October 2014 At present, China's new GMP appendix "validation and validation" is in the process of formulation, has completed the consultation, and has not yet been released From the content point of view, the draft is closer to the previous EU annex 15 The release of the revised draft of EU annex 15 will have a great impact on the formulation of the new GMP annex "validation and validation".