The Good Manufacturing Practice (GMP) guidance for sterile manufacture was revised in 2003 to accommodate changes from various cleanroom standards to create a single unified cleanroom standard, ISO 14644-1. The introduction to ISO 14644-1 states this as: Annex 1 of the EC Guide to Good ...
The scope of the AI Act is very wide, covering systems developed through an array of approaches that are listed in Annex I of the AI Act. These include machine learning approaches that also incorporate deep learning; logic and knowledge-based approaches; as well as statistical approaches, ...
Commission Delegated Regulation (EU) 2021/2139 of 4 June 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to cl...
Despite the recognized health effects and the strict regulatory measures to manage exposure to Cr(VI) at workplaces, including the need for authorization (a temporary permit) for the continued use of hexavalent chromium compounds in the EU (Annex XIV of REACH regulation), Cr(VI) is still much...
In this provision, ‘for every biocidal product or biocidal product family authorised by the Union’ may be treated as separate IF next to ‘The Agency’ or as part of the THEN statement (’shall levy the annual fees provided for in Annex III’). Exceptions. Disagreement was observed on wh...
Regulation (EU) 2015/2030 amending Annex I, defines the prohibition criteria of SCCPs in substances and mixtures: The production, placing on the market and use of substances or preparations containing SCCPs in concentrations lower than 1 % by weight sh...
Vol. 1205 | 16 Dec 2020 The European Union issued an amendment to REACH in the official journal on 16th December 2020. Commission Regulation (EU) 2020/2096 of 15 December 2020 amends Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning t...
the issue of public finance sustainability is somewhat incompletely highlighted in the Treaty and there is not an explicit reference to any accepted notion of public finance “sustainability”. It is simply stipulated in the Annex Protocol that there are two “reference values”: a public deficit/...
2、可以查看最新更新文件,如2019年1月29日发布的“Document updated - Manufacture of Biological active substances and Medicinal Products for Human Use (EudraLex, Volume 4, Annex 2)”; 3、欧盟GMP链接 https://ec.europa.eu/health/documents/eudralex/vol-4_en; ...
欧洲GMP指南Chapter4Documentation第四章文件Chapter5Production第五章生产Chapter6QualityControl第六章质量控制Chapter7ContractManufacturingandAnalysis第七章外包生产和样品分析Chapter8ComplaintsandProductRecall第八章投诉和成品召回Chapter9SelfInspection第九章自检12EUGMP--中英对照EUGuidelinestoGMP 欧洲GMP指南Annex1Manufactur...