药品生产质量管理规范版ENWord文档格式.docx

1、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 Peoples Republic of China” and “The Regulation on the Implementation of Dr

2、ug Administration Law of the Peoples 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 ensuri

3、ng 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 pro

4、cess 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 fa

5、ith, 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

6、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 i

7、ntending 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

8、 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 systems effective running. Article 9 Quality guarantee

9、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 s

10、tocked 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 persons ap

11、proval;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 require

12、ments 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 req

13、uired 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. Appli

14、cable 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. Ba

15、tch record and delivering record shall be traced back to the whole history of the batch of products, and the records shall be saved appropriately and be easy consult;VIII. Reduce the quality risk during the pharmaceutical goods delivering process;IX. Establish pharmaceutical goods recall system, and

16、 ensure any batch delivered and sold products could be recalled;X. Survey the reasons leading to pharmaceutical goods complaints and quality objections, take measures to prevent similar quality objections.Section 3 Quality ControlArticle 11 Quality control includes corresponding organization, docume

17、nt system and sampling, test and so on, to ensure material or products finish necessary examination before delivering, and to verify its quality is in accordance with the requirements.Article 12 Basic requirements of quality control:I. Equip applicable establishment, equipment, instrument and traine

18、d personnel to effective and reliable finish all related quality control activities;II. Have approved operate rules, which used to sampling, examine, inspect raw material, wrapper, semifinished product, bulk product and finished product and products stability, monitor environment when necessary, to

19、ensure the products is in accordance with the requirements of this Regulation;III. Authorized person shall sampling to raw material, wrapper, semifinished product, bulk product and finished product according to stated methods;IV. Inspect methods shall be confirmed and validated;V. Sampling, check, i

20、nspect shall be recorded, the windage shall be researched and be recorded;VI. Material, semifinished product, bulk product and finished product shall be checked and inspected according to quality standard and be recorded;VII. Material and packaged finished product shall have enough reserved samples

21、so that necessary check or inspect shall be taken; except the finished product with too large package container, the reserved samples package shall be the same with the final package of the finished product.Section 4 Quality Risk ManagementArticle 13 Quality risk management is evaluate, control, com

22、municate, audit system process to quality risk during the whole product life period, via the manner of foresee or review.Article 14 Quality risk shall evaluate according to science knowledge and experience in order to ensure products quality.Article 15 The method, measure, form take during the quali

23、ty risk management process and the documents formed in the said process shall accommodate to the level of the existent risk. Chapter 3 Organization and PersonnelArticle 16 An enterprise shall establish management organization which accommodate to the pharmaceutical goods product and have its organiz

24、ation framework chart.The enterprise shall set up independent quality management department, which carries out the responsibilities of quality guarantee and quality control. The quality management department could set up quality guarantee department and quality control department respectively.Articl

25、e 17 Quality management department shall take part in all activities relating to quality, and take responsibility to audit all documents relating to this Regulation. The personnel in quality management department shall not relegate his responsibility to the personnel in other department.Article 18 T

26、he enterprise shall be staffed by an appropriate number of management and technical personnel with appropriate qualification （including education background, training and practice experience）, and the responsibilities of each department and each station shall be clarified. Stations responsibility sh

27、all not be missed and cross responsibility shall be prescribed specifically. Responsibility taken by each person shall not be overfull.Every person shall clear and understand his own responsibilities, be familiar with the requirements related to his responsibilities, and accept necessary training, i

28、ncluding pre-job training and on-job training.Article 19 Generally, one shall not relegate his responsibility to other person. If the responsibilities do need to be relegated, the one should relegate his responsibility to the designated person who has equivalent qualification. Section 2 Important Pe

29、rsonArticle 20 The important person shall be the full-time person of the enterprise, at least including the director of the enterprise, director of manufacturing management, director of quality management and authorized person of quality.Director of quality management and director of manufacturing m

30、anagement shall be independent of each other. Director of quality management and authorized person of quality shall not be independent of each other. Operation proceduress shall be established so that authorized person of quality could take his responsibility independently, with no interference from director of enterprise and other person. Article 21 Director of enterpriseDirector of enterprise is the main responsible person of pharmaceutical goods quality, who comprehensive responsible to the daily management of the enterprise. In order to ensure the