Order of the Ministry of Health of the People's Republic of China
No.79
Good Manufacturing Practice for Pharmaceutical Products (2010 Revision), as deliberated and adopted at the MOH executive meeting on October 19, 2010, is hereby issued, and shall come into force on March 1, 2011.
Minister CHEN Zhu
January 17, 2011
Good Manufacturing Practice for Pharmaceutical Products
(2010 Revision)
药品生产质量管理规范（2010年修订）
Chapter 1 General Provisions
Article 1 To normalize the quality management of pharmaceutical production, the Good Manufacturing Practice for Pharmaceutical Products (hereinafter referred to as “the Practice”) is formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China and the Regulations for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China.
Article 2 An enterprise shall establish a quality management system for pharmaceutical products, which shall cover all factors affecting the quality of pharmaceutical products, including all organized and planned activities ensuring that the pharmaceutical products meet the intended use.
Article 3 As a part of the quality management system, the Practice serves as the basic requirements for pharmaceutical production management and quality control, aiming at minimizing the risks of contamination, cross-contamination, confusion and errors in the process of pharmaceutical production, and ensuring the consistent and steady production of pharmaceutical products that meet the intended use and registration requirements.
Article 4 An enterprise shall strictly implement the Practice, adhere to honesty and good faith, and prohibit any falsehood or fraud.
Chapter 2 Quality Management
Section 1 Principles
Article 5 An enterprise shall establish quality objectives that meet the quality management requirements for pharmaceutical products, systematically implement all the requirements of pharmaceutical product registration on safety, effectiveness and quality control in the whole process of pharmaceutical production, control, product release, storage and shipment, and ensure that the pharmaceutical products produced meet the intended use and registration requirements.
Article 6 The senior management of an enterprise shall ensure that the established quality objectives are achieved, and personnel at different levels, suppliers and distributors shall jointly participate and assume their respective responsibilities.
Article 7 An enterprise shall have an adequate number of competent personnel, premises, facilities and equipment to provide necessary conditions for the attainment of the quality objectives.
Section 2 Quality Assurance
Article 8 Quality assurance is part of the quality management system. An enterprise must establish a quality assurance system and a sound documentation system to ensure the effective operation of the quality assurance system.
Article 9 The quality assurance system shall ensure that:
(1)pharmaceutical products are designed and developed in a way that satisfies the requirements of the Practice;
(2)production management and quality control operations comply with the requirements of the Practice;
(3)managerial responsibilities are clearly specified;
(4)raw and auxiliary materials, and packaging materials are properly purchased and used;
(5)Intermediate products are effectively controlled;
(6)qualifications and validations are carried out;
(7)production, inspection, testing and verification are carried out in strict accordance with the defined procedures;
(8)each batch of products are released only upon the approval of the quality authorized person;
(9)appropriate guarantees for the quality of pharmaceutical products are in place during storage, shipment and subsequent operations; and
(10)the effectiveness and applicability of the quality assurance system are regularly inspected and appraised according to the operation procedure for self-test.
Article 10 Basic requirements for the quality management of pharmaceutical production are as follows:
(1)production processes are established, systematically reviewed and demonstrated to be capable of producing satisfactory products consistently and steadily;
(2)the production processes and the material changes thereof are validated;
(3)necessary resources are provided, at least including:
1.appropriately qualified and trained personnel;
2.adequate premises and space;
3.suitable equipment and maintenance support;
4.correct raw and auxiliary materials, packaging materials and labels;
5.approved technological procedures and operation procedures; and
6.appropriate storage and transportation conditions.
(4)operation procedures shall be written in unambiguous and easily legible language;
(5)operators are trained to operate correctly according to the operation procedures;
(6)records are maintained during the whole manufacturing process and deviations are investigated and recorded;
(7)batch records and shipment records, which enable traceability to the complete history of a batch, are retained properly for easy consultation;
(8)any risk to the quality of pharmaceutical products is mitigated during their shipment;
(9)a pharmaceutical product recall system is established to enable recall of any batch of products from shipment or sale;
(10)the causes of pharmaceutical product complaints and quality defects are investigated, and measures taken in respect of the defective products to prevent recurrence.
Section 3 Quality Control
Article 11 Quality control involves the relevant organization, documentation system, sampling, testing, etc. which ensures that necessary tests are actually carried out before the release of materials or products, until their quality has been judged to be satisfactory.
Article 12 The basic requirements for quality control are as follows:
(1)appropriate facilities, equipment and apparatuses shall be equipped and trained personnel must be staffed to ensure that all the quality control activities are effectively and reliably carried out;
(2)approved operation procedures shall be available for sampling, inspecting, and testing raw and auxiliary materials, packaging materials, and intermediate, bulk, and finished products, and for product stability examinations, and environmental monitoring is carried out when necessary to ensure compliance with the requirements of the Practice;
(3)samples of raw and auxiliary materials, packaging materials, and intermediate, bulk and finished products are taken by the authorized personnel according to the prescribed methods;
(4)test methods shall be qualified or validated;
(5)records are maintained for sampling, inspection and testing and any deviations are investigated and recorded;
(6)the materials and intermediate, bulk and finished products must be inspected and tested against quality standards, and records must be maintained;
(7)sufficient samples of materials and final products shall be retained to allow future inspection or testing; the retained sample for finished products, except for those whose final pack is exceptionally large, shall have the same pack as the final pack.
Section 4 Quality Risk Management
