Good Distribution Practices (GDP)for Pharmaceutical Products
Good Distribution Practices (GDP)for Pharmaceutical Products
Good Distribution Practices (GDP)for Pharmaceutical Products
Order of the director of the State Drug Administration [2000] No. 20
April 30, 2000
The Good Distribution Practices (GDP)for Pharmaceutical Products, which was deliberated and adopted at the executive meeting of the State Drug Administration on March 17, 2000, is hereby promulgated and shall come into effect as of July 1, 2000.
Attached: Good Distribution Practices (GDP)for Pharmaceutical Products
Chapter I General Provisions
Article 1 For the purposes of strengthening the administration of operation quality of drugs and ensuring the safety and effectiveness in the medication of people, the Good Distribution Practices for Pharmaceutical Products (hereinafter referred to as the GSP) is formulated in accordance with the Law of the People's Republic of China on the Administration of Drugs and other relevant laws and regulations.
Article 2 Drug operating enterprises shall carry out quality management in such links as the purchase, storage, transportation and sale of drugs and establish quality systems in aspects including organizational structure, responsibility system, process management and facilities and equipment so as to make the same operate effectively.
Article 3 GSP constitutes the basic standards in management of operation quality of drugs and shall apply to enterprises exclusively or concurrently engaged in drug operation within the territory of the People's Republic of China.
Chapter II Quality Management of Drug Wholesale
Section 1 Management Responsibilities
Article 4 The principal of an enterprise shall ensure the implementation of relevant laws, regulations and GSP by the enterprise and assume leadership responsibilities for the quality of drugs operated by the enterprise.
Article 5 An enterprise shall establish quality leadership organization led by the principal of the enterprise, the main responsibilities of which are: establishing quality systems of the enterprise, implementing quality policy of the enterprise, and ensuring the power exercising of quality management working personnel of the enterprise.
Article 6 An enterprise shall set up special quality management institution to exercise quality management functions, which shall have the right to judge the drug quality inside the enterprise.
Article 7 An enterprise shall set up a drug inspection department and an organization for inspection, acceptance and maintenance appropriate to its operation scale. The drug inspection department and inspection and acceptance organization shall be subordinate to the quality management institution.
Article 8 An enterprise shall, in accordance with relevant laws, regulations and GSP, formulate quality management system in consideration of the actual situation of the enterprise and regularly examine and assess the implementation of the system.
Article 9 An enterprise shall regularly conduct internal review of the implementation of GSP to ensure the implementation of GSP.
Section 2 Personnel and Training
Article 10 The principal of an enterprise shall have professional and technical titles and be familiar with laws, regulations and rules of the state concerning drug management and the knowledge of drugs operated by the enterprise.
Article 11 The responsible persons of an enterprise shall include personnel with professional and technical titles in pharmacy, who shall be responsible for quality management work.
Article 12 The responsible person of the quality management institution of an enterprise shall be a licensed pharmacist or a person that has corresponding professional and technical titles in pharmacy, can adhere to principles, has practical experience, and can independently solve quality problems in the course of operation.
Article 13 The responsible person of the drug inspection department shall have corresponding professional and technical titles in pharmacy.
Article 14 The personnel of an enterprise who engage in quality management and inspection work shall have a degree in pharmacy or related major or have professional and technical titles in pharmacy and shall not take the post unless being certified after receiving professional training and assessment.
Article 15 The personnel engaging in inspection & acceptance, maintenance, measurement, safekeeping and other work shall have a corresponding degree or certain educational background and shall not take the post unless being certified after receiving relevant training and assessment.
The personnel working on posts regarding which the state has provided employment access shall go through occupational skill appraisal and obtain professional qualification certificate before taking the post.
Article 16 An enterprise shall organize the personnel that have direct contact with drugs to receive health examination and establish health files. When finding any patients suffering from mental disease, infectious disease or other diseases that may contaminate drugs, it shall transfer such patients from the post on which the patients have direct contact with drugs.
Article 17 An enterprise shall regularly conduct education or training among various personnel regarding law, regulations and rules on pharmacy, professional technique, pharmacy knowledge, professional ethics, etc. and establish files.
Section III Facilities and Equipment
Article 18 An enterprise shall have the place of business as well as subsidiary and office housing. The place of business shall be bright and neat.
Article 19 An enterprise shall have warehouse appropriate to the business scale. The warehouse area shall be flat and smooth on the floor, be free from standing water and week, have no pollution source, and shall ensure:
1. The drug storage operation area, auxiliary operation area and office & living area shall be kept a certain distance from each other or have quarantine measures and loading and unloading operation location shall have ceilings.
2. Have warehouse suitable for the type-by-type storage of drugs that conform to requirements for drug storage.
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