药品生产质量管理规范（2010年修订）-英文版.doc

药品生产质量管理规范（2010年修订）中文版http://www.yaojia.org/forum-viewthread-tid-18492-fromuid-1023.htmlGood Manufacturing Practice for Pharmaceutical Products(Amended in 2010) SDA Order #79Order by Ministry of Health of the People’s Republic of China　　　　　　Published on February 12, 2011 No. 79Good Manufacturing Practice for Pharmaceutical Products (Amended in 2010) has passed by Affairs Meeting on October 19, 2010. This Regulation is now published and shall be effective from March 1, 2011.　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　Director Zhu CHEN　　　　　　　　　　　　　　　　　　　　　　　 　　　　January 17, 2011Chapter 1 General ProvisionsArticle 1 In order to standardize good manufacturing for pharmaceutical products, this Regulation is enacted in accordance with the “Drug Administration Law of the People’s Republic of China” and “The Regulation on the Implementation of Drug Administration Law of the People’s Republic of China”. Article 2 A pharmaceutical enterprise shall establish pharmaceutical goods’ quality control system. The system shall contain all factors which may affect the quality of pharmaceutical goods, including all organized and planned activities ensuring pharmaceutical goods’ quality in accordance with intending purpose. Article 3 This Regulation is part of quality control system, is basic requirement for manufacturing and quality control of pharmaceutical products. This Regulation aims to reduce the risks in pharmaceutical goods’ manufacturing process at its maximum, such as pollution, cross pollution and confusion, mistake, ensure for continuous stably manufacturing pharmaceutical goods in accordance with intending purpose and registered requirements.Article 4 The enterprise shall obey this Regulation strictly, insist on honesty and keep faith, prohibit any ostensible and spurious activities.　　　　　　　　　　　　　　　　　　　Chapter 2 Quality Control　　　　　　　　　　　　　　　　　　　 Section 1 PrincipleArticle 5 The enterprise shall establish quality target in accordance with pharmaceutical goods’ quality control requirements, carry out all requirements related to safety, effective and quality control into the process of pharmaceutical goods’ manufacturing, control and products’ discharging, storage, delivering, ensure all pharmaceutical goods are produced in accordance with intending purpose and registered requirements. Article 6 Senior administrator in enterprise shall ensure the achievement of intending quality target. Personnel in different levels and provider, dealer shall participate in and take each responsibility.　 Article 7 The enterprise shall equip adequate personnel, workshop, establishment and equipment in accordance with requirements, and provide essential condition for achieving quality target.Section 2 Quality GuaranteeArticle 8 Quality guarantee is a part of quality control system. The enterprise must establish quality guarantee system, and establish integrate document system at the same time, in order to ensure the system’s effective running. Article 9 Quality guarantee system shall ensure the following: I. Represent the requirements of this Regulation in pharmaceutical goods’ design and development.II. In accordance with the requirements of this Regulation in manufacturing management and quality control activities;III. Specific management responsibility;IV. Exact stocked and used raw material and wrapper;V. Effective control in semifinished product;VI. Implement of confirmation and validation;VII. Manufacture, examine, inspect and double examined according to rules strictly;VIII. Each batch of products shall only discharge after quality authorizing person’s approval;IX. Applicable measures to ensure pharmaceutical goods’ quality during the process of storage, delivering and all succedent operation process;X. According to self-examine rules, examine and evaluate the validity and applicability of the quality guarantee system quality.Article 10 Basic requirements of pharmaceutical goods’ manufacture quality management:I. Frame manufacturing technique, systemic review and demonstrate it could continuous stably manufacturing products in accordance with requirements;II. Manufacturing technique and its important changes shall be validated;III. Equip all required resources, include, but not limited the following:1. Hold applicable qualification and the eligible trained personnel;2. Adequate workshop and space;3. Applicable equipment and maintain guarantee;4. Accurate raw material, wrapper and label;5. Approved technique rules and operate rules;6. Applicable storage and freight condition.IV. Use accurate and easy understand language to frame operate rules;V. The operate person could accurate operate according to operate rules after training;VI. The whole manufacture process shall be recorded. The windage shall be researched and be recorded;VII. Batch record and delivering record shall be traced back to the whole。