FDA Issues Final Rule Clarifying Certain cGMP Regulations

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FDA Issues Final Rule Clarifying Certain cGMP Regulations

机译：FDA发布澄清某些cGMP法规的最终法规

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The FDA has issued a final rale revising and clarifying its current good manufacturing practice (cGMP) requirements for aseptic processing, water standards and the verification of production steps. The changes, which the agency says will not have a substantially adverse impact on the industry, were issued in part to harmonize cGMP standards with other pharmaceutical regulators, such as the European Medicines Agency.

机译：FDA已发布最终规章，对无菌加工，水标准和生产步骤验证方面的现行良好生产规范（cGMP）要求进行了修订。该机构表示，所做的变更不会对行业造成实质性的不利影响，部分原因是为了与其他药品监管机构（例如欧洲药品管理局）协调cGMP标准。

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《Washington Drug Letter》 |2007年第48期|p.7-8|共2页
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正文语种 eng
中图分类生物科学;
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7. Report drawn up on behalf of the Committeeon Agriculture on A. the proposals from the Commission of the European Communities to the Council (Doc. 1-893/83-COM(83) 548 final) for: I. a regulation amending Regulation (EEC) No. 804/68 on the common organization of the markets in milk and milk products. II. a regulation laying down general rules applying to the milk sector levy specified in Article 5(c) of Regulation (EEC) No. 804/68. III. a regulation laying down general rules applying to the milk sector levy specified in Article 5(d) of Regulation (EEC) No. 804/68. B. the proposals from the Commission of the European Communities to the Council (Doc. 1-996/83-COM(83) 611 final) for: I. a regulation amending Regulation (EEC No. 1723/81 as regards the possibility of granting aids for the use of butter in the manufacture of certain food-stuffs. II. a regulation amending Regulation (EEC) No. 1411/71 as regards the fat content of drinking milk. III. a regulation laying down general rules on the granting of aid for concentrated skimmed milk and concentrated milk for use as animal feed. IV. a regulation amending Regulation (EEC) No. 1269/79 with regard to the terms for the disposal of butter at a reduced price for direct consumption. C. the proposal from the Commission of the European Communities to the Council (Doc. 1-1113/83)-COM(83) 644 final) for a regulation amending Regulations (EEC) No. 1078/77 introducing a system of premiums for the non-marketing of milk and milk products and for the conversion of dairy herds. [O] . Woltjer E. 1984

机译：代表农业委员会编写的报告a.欧洲共同体委员会向理事会提交的建议（文件1-893 / 83-COm（83）548最终决定）：I。修订条例的规定（欧洲经济共同体））关于牛奶和奶制品市场共同组织的第804/68号。 II。规定适用于第804/68号条例（EEC）第5（c）条规定的牛奶部门征税的一般规则。 III。规定了适用于第804/68号条例（EEC）第5（d）条规定的牛奶部门征税的一般规则。 B.欧洲共同体委员会向理事会提交的提案（文件1-996 / 83-COm（83）611最终决定）：I。修订条例的规定（欧洲经济共同体第1723/81号关于可能性的规定）在制造某些食品时使用黄油的辅助手段.II。修订关于饮用牛奶脂肪含量的第1411/71号条例（EEC）的规定.III。关于授予的一般规则的规定对用作动物饲料的浓缩脱脂奶和浓缩奶的援助.IV。修订第1269/79号条例（EEC）关于以低价直接食用黄油的条款的规定。欧洲共同体委员会向理事会提交的文件（文件1-1113 / 83）-COm（83）644 final）关于修订第1078/77号条例（EEC）的法规，引入了非保险费制度销售牛奶和奶制品以及奶牛转换。

FDA Issues Final Rule Clarifying Certain cGMP Regulations

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