Good Manufacturing Practice for Pharmaceutical Products
(Amended in 2010)
SDA Order #79
Order by Ministry of Health of the People’s Republic of China
Published on February 12, 2011
No. 79
Good 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, 2011
Chapter 1 General Provisions
Article 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 p harmaceutical 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 g oods’ manufacturing process at its maximum, such as pollution,
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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 Principle
Article 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, storag e, 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 Guarantee
Article 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 e ffective 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 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 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 Control
Article 11 Quality control includes corresponding organization, document 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 trained 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 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, inspect 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 so that necessary check or inspect shall be taken; except the finished product with too large package container, the reserved sample s’package shall be the same with the final package of the finished product.
Section 4 Quality Risk Management
Article 13 Quality risk management is evaluate, control, communicate, 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 quality risk management process and the documents formed in the said process shall accommodate to the level of the existent risk.
Chapter 3 Organization and Personnel
Section 1 Principle
Article 16 An enterprise shall establish management organization which accommodate to the pharmaceutical goods’ product and have its organization 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.
Article 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
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