(SDA Order No. 20)
The "Good Sales Practice for Pharmaceutical Products" ("GSP"), which was reviewed and approved at the Administration Affairs Meeting of SDA on March 17, 2000, is hereby promulgated and shall go into effect on July 1, 2000.
Director-General: Zheng Xiaoyu
April 30, 2000
Chapter 1: General Principles
Article 1: According to the "Drug Administration Law of the People's Republic of China" and other relevant laws and regulations, this "Good Sales Practice of Pharmaceutical Products"(hereinafter "GSP") is promulgated in order to strengthen quality control in the distribution of drugs and ensure the safe and efficacious use of drugs by people.
Article 2: A drug operation enterprise shall implement quality control in the process of drug procurement, storage, transportation and sale, establish a quality system which includes organizational structure, responsibility allocation, process management, equipment and facilities, etc., and ensure the effective operation of such a system.
Article 3: This "GSP" is the basic principles of quality control in the distribution of drugs and shall be observed by both specialized and non-specialized drug operation enterprises.
Chapter 2: Quality Control in Wholesale Drug
Section 1: Management Duties
Article 4: The chief responsible person of a drug wholesale enterprise shall ensure the implementation of relevant laws, regulations, and this "GSP" by the enterprise, and shall hold the leadership responsibility position for the quality of drugs in which the enterprise transacts business.
Article 5: A wholesale enterprise shall establish a leading quality control group headed by the chief responsible person of the enterprise. The team shall be mainly responsible for the establishment of quality system and the implementation of quality control principles within the enterprise, and shall ensure the exercise of authority by the quality control personnel of the enterprise.
Article 6: A wholesale enterprise shall set up a special quality control department to perform quality control functions. The department shall have the authority over drug quality issues within the enterprise.
Article 7: A wholesale enterprise shall set up a drug acceptance and inspection departments for acceptance, inspection and preservation, etc. Such departments shall be commensurate with the business scale of the enterprise, and operate under the authority of the quality control department.
Article 8: A wholesale enterprise shall establish rules of quality control according to relevant laws, regulations and this "GSP" based on the actual conditions of the enterprise. Periodical inspection and examinations shall be conducted to check implementation.
Article 9: A wholesale enterprise shall periodically conduct internal evaluation of "GSP" implementation so as to ensure its implementation.
Section 2: Personnel and Training
Article 10: The chief responsible persons of a wholesale enterprise shall possess a professional technical title, be familiar with relevant laws, regulations and rules of drug administration, and have knowledge of the drugs in which the enterprise transacts business.
Article 11: Staff possessing technical titles in pharmacology shall be included in the responsible persons of a wholesale enterprise, and shall be in charge of quality control work.
Article 12: The responsible person of the quality control department of a wholesale enterprise shall be a licensed pharmacist or possess equivalent professional technical title in pharmacology. The person shall uphold relevant principles, have practical experience, and be capable of independently solving quality problems occurring in business operations.
Article 13: The responsible person of the drug inspection department of a wholesale enterprise shall possess corresponding technical titles in pharmacology.
Article 14: The employees of a wholesale enterprise responsible for quality control and inspection shall have relevant educational background in pharmacology or related disciplines, or possess technical titles in pharmacology, and shall obtain professional certificate by accepting relevant professional training and examinations before assuming positions.
Article 15: The employees of a wholesale enterprise responsible for the acceptance, inspection, preservation, measurement, and storage of drugs shall have appropriate educational background and have obtained corresponding educational certificate, and shall obtain professional certificate by completing relevant professional training and examinations before assuming the positions.
The employees working in the positions for which the government has relevant qualification requirements shall have passed technical assessment and obtained required certificates before assuming the positions.
Article 16: A wholesale enterprise shall organize physical examinations for its employees who have direct contact with drugs and shall establish health files for such employees. Any employees that are found to have psychiatric, contagious or other diseases that might contaminate drugs shall be immediately removed from positions which have direct contact with drugs.
Article 17: A wholesale enterprise shall periodically conduct training for its employees on relevant laws, regulations, rules, professional skills, drug knowledge, and ethics, etc., and shall establish relevant files.
Section 3: Facilities and Equipment
Article 18: A wholesale enterprise shall have a business site, office space and other supplementary spaces commensurate with its business scale. The business site shall be bright and well kept.
Article 19: A wholesale enterprise shall have a warehouse commensurate with its business scale. The ground surface of the warehouse area shall be level, free of water pools, weeds and other pollution sources. The warehouse shall meet following requirements:
1. There shall be a certain distance or facilities separating operation zones for drug storage, auxiliary operations, and office work. The area for loading and unloading of drugs shall be sheltered.
2. There shall be warehouses that can store drugs according to different drug categories and meet relevant requirements of drug storage. The surface of the wall, ground and the ceiling of the warehouses shall be plain and level, and the structures of the doors and windows shall be well sealed.
3. The warehouse area shall be equipped with required fire extinguishers and security facilities.
Article 20: Warehouses shall be divided into specialized warehouses (zones) respectively for pending inspection, qualified products, delivery, unqualified products, and returned products. For enterprises dealing in TCM, there shall be a special warehouse (zone) for the weighing of drugs for retail. Each warehouse (zone) shall be clearly marked.
Article 21: Warehouses shall have following facilities and equipment:
1. facilities to maintain the space between drugs and the ground surface;
2. equipment for protection from light, ventilation and drainage;
3. equipment to test and adjust temperature and humidity;
4. equipment to prevent dust, humidity, mildew and rot, pollution, bugs, rats, and birds, etc.;
5. lighting equipment that meets the requirements of safe use of electricity; and
6. work zones for dismantling, consolidation, and delivery of goods, and storage areas and facilities for packaging materials.
Article 22: The special warehouses for the storage of narcotic drugs, Class I psychiatric drugs, toxic drugs for medical use, and radioactive drugs shall have proper security measures and facilities.
Article 23: A wholesale enterprise shall have a drug inspection department which is commensurate with the scale and scope of its business and equipped with corresponding testing instruments and equipment. Wholesale enterprises conducting business in TCM herbs and preparations shall have TCM sample rooms (cabinets).
Article 24: A wholesale enterprise shall have rooms for the preservation and acceptance and inspection of drugs, equipped with necessary tools, instruments and equipment that meet hygienic requirements and are commensurate with the scale of business.
Article 25: Facilities and equipment used in a wholesale enterprise shall be periodically examined, repaired, and maintained. Relevant files shall be established.
Article 26: A special work zone shall be set aside for the repackaging of TCM preparations, the area and relevant equipment of which shall conform with relevant requirements.
Section 4: Drug Procurement
Article 27: Drug quality shall be the top consideration of a wholesale enterprise in selecting drugs and suppliers. Proper procurement procedures shall be established to ensure that the quality of drugs purchased conform to relevant quality requirements.
Article 28: The drugs purchased shall meet following requirements:
1. be manufactured and distributed by legitimate enterprises;
2. have legitimate quality standards;
3. unless not required by the state, have legitimate approval number and production batch numbers. Conforming photocopies of "Import Drug Registration Certificate" and "Import Drug Inspection Report" with the seal of the quality inspection department of the relevant supplier are required for import drugs;
4. be packed and labeled according to relevant regulations and relevant storage and shipment requirements;
5. TCM shall be clearly marked with the place of origin.
Article 29: The business and quality departments of a wholesale enterprise shall check the qualification of a first-time supplier and its capability to ensure drug quality. The enterprise may also conduct on-site inspection whenever necessary in addition to checking written documents. Only when the supplier has passed the check, may the enterprise purchase drugs from the supplier.
Article 30: A wholesale enterprise shall check the legality and quality conditions when initially handling a drug (including new specifications, new dosage form, and new packaging, etc.). Distribution of the drug may only start after it has passed the check.
Article 31 Drug quality shall be the top consideration of a wholesale enterprise in making procurement plans. The personnel from the quality control department of the enterprise shall participate in the drafting of the procurement plans.
Article 32: Articles regarding drug quality shall be explicitly stated in a purchase contract.
Article 33: There shall be legitimate documentation (receipts, invoices and other documents) in purchasing drugs. Purchasing records shall be established according to relevant regulations to ensure that documentation, account books and goods are consistent with one another. Purchasing records shall be maintained according to relevant regulations.
Article 34: An enterprise shall annually assess the quality of drugs purchased.
Section 5: Acceptance and Inspection
Article 35: Acceptance in drug quality control means:
1. In procurement, the quality of drugs shall be strictly checked according to relevant legitimate quality standards and the quality terms stipulated in relevant contract provisions. Drugs which are returned shall be inspected batch by batch.
2. Drug packaging, labels, insert sheets and other relevant certificates or documents shall all be checked during acceptance.
3. Samples checked during acceptance shall be representative.
4. Checking during acceptance shall be carefully recorded according to relevant regulations, and the records shall be maintained at least one year after the expiration of the concerned drugs, but in any event, not less than three years.
5. In initially handling a drug, its quality shall be inspected during acceptance.
6. Checking during acceptance shall be conducted at a proper site according to relevant regulations and shall be completed within the required time period.
Article 36: A warehouse shall accept drugs against the signature or seal of the party accepting the goods. In case of discrepancy between documents and goods, or unusual conditions of quality, loose or damaged packaging, unclear labels, the warehouse may refuse to accept the drugs and report the matter to relevant departments of the enterprise.
Article 37: The drug inspection department of a wholesale enterprise shall be responsible for the inspection of drugs purchased by the enterprise, and the provision of accurate and reliable inspection data.
Article 38: The number of batches from which samples are drawn for inspection shall be in the required proportion of the total number of batches purchased according to relevant regulations.
Article 39; The quality control during acceptance and inspection of drugs shall mainly include:
1. the collection, distribution and filing of relevant regulations and standards relevant to drug quality;
2. the principles and procedures of sampling, and operational rules for checking during acceptance and inspections;
3. methods to handle the situation when problems are discovered;
4. the periodic calibration and examination of instruments, equipment, measuring and weighing devices, and the use, maintenance and registration of the instruments;
5. the establishment, collection, filing, and maintenance of original records and drug quality files; and
6. the collection and preservation of TCM samples.
Article 40: A wholesale enterprise shall implement quality control measures for drugs failing to meet requirements which focus on:
1. reporting such drugs according to relevant requirements and procedures;
2. labeling and storage of such drugs;
3. identification of the reasons the drug failed to meet requirements, clarification of relevant responsibilities, timely handling, and promulgation of preventive measures;
4. records of the destruction and disposal of such drugs; and
5. summary and analysis of the handling of such drugs.
Section 6: Storage and Preservation
Article 41: A drug shall be stored in specialized warehouses according to category classification as stipulated by relevant regulations. The following requirements shall be observed for drug storage:
1. A drug shall be stored in a warehouse which conforms with its temperature and humidity requirements.
2. Color coding shall be used in to manage drugs stored in a warehouse.
3. Requirements distributed by the diagrams on the external package of drugs shall be strictly observed in moving and stacking of drugs according to standard operations. Height of stacks shall be controlled for drugs that are marked with "not to be stowed below other cargo". The stacks shall be periodically turned.
4. A certain distance or separation shall be maintained between drugs and radiators or the floor, wall, and ceiling of a warehouse.
5. Drugs of the same batch shall be stored together. Drugs which have not expired shall be stored together with the same category of drugs according to the sequence of batch numbers or expiration dates, and be clearly marked by color coding.
6. Drugs and non-drugs, internal use drugs and external use drugs, prescription drugs and OTC drugs, shall be separately stored. Drugs with strong smell that may affect other drugs, TCM herbs and preparations, and dangerous drugs shall be separately stored away from other drugs.
7. Narcotics, Class I psychiatric drugs, toxic drugs for medical usage, and radioactive drugs shall be stored in specialized warehouses or cabinets with two locks managed by two persons, and be separately recorded.
Article 42: The main duties of drug preservation management are:
1. providing guidance to custodians responsible for the reasonable storage of drugs;
2. examining the storage conditions of warehoused drugs, coordinating with custodians on the adjustment of the temperature and humidity of warehouses;
3. conducting periodical inspection on the quality of drugs in storage and maintenance of proper inspection records;
4. using drying, oxygen reduction, fumigation or other method to preserve TCM herbs or preparations according to their respective characteristics;
5. sending samples for inspection from drugs that may have quality problems caused by unusual reasons, or TCM herbs which have been stored for a long period of time;
6. timely notification of relevant quality control departments of problems detected for further re-examination and handling;
7. periodically providing to supervisors summaries, analysis and reports of preservation inspections, quality status information of drugs that are close to their expiration dates or have been stored for a long period of time;
8. management of preservation instruments and equipment, temperature and humidity monitoring and testing instruments, measurement instruments or devices that are in use, etc.; and,
9. establishing drug preservation files.
Section 7: Drug Distribution from Warehouse and Transportation
Article 43: Drugs shall be distributed from a warehouses following the principles of "first produced first out", "drugs with closer expiration dates out first" and "delivery according to batch numbers".
Article 44: Drugs distributed from a warehouse shall undergo verification and quality inspection. A dual-person-checking system shall be established for narcotics, Class I psychiatric drugs and toxic drugs for medical use.
Article 45: Drug quality tracking records shall be properly maintained for drug distribution to ensure an instant and accurate quality tracking. The records shall be maintained at least one year after the expiration of the relevant drug, but, in any event, not less than three years.
Article 46: Drugs with special requirements for temperature shall be transported according to necessary heating or refrigeration measures with consideration of difference of seasonal temperatures and distance of transportation.
Article 47: Relevant regulations shall be observed for the transportation of narcotics, Class I psychiatric drugs, toxic drugs for medical purposes and dangerous drugs.
Article 48: A distributor shall first conduct quality inspection on the drugs that will be directly delivered to its customer from the manufacturer of the drugs (direct delivery of drugs).
Article 49: Drugs shall be handled with care in moving, loading and unloading, stacking and adoption of protection measures shall be undertaken strictly according to the requirements indicated by the diagrams printed on the external packages of the drugs.
Section 8: Sales and After-sales Service
Article 50: A wholesale enterprise shall sell drugs to units with legitimate qualifications according to relevant laws, regulations and rules.
Article 51: The sales of drugs under special administration shall strictly observe relevant regulations.
Article 52: Sales persons shall appropriately promote drugs and shall not exaggerate or make false claims of the effects of drugs, or mislead users.
Article 53: Legitimate receipts, invoices and other documents shall be issued for sales transactions. Sales records shall be established according to relevant regulations to ensure that receipts, invoices, and other document, account books and goods are all consistent with each other. Sales documents and records shall be maintained according to relevant regulations.
Article 54: A wholesale enterprise shall ensure the quality of drugs that are purchased from other distributors and directly delivered to customers because of special situations, and shall timely make records.
Article 55: Promotional material for a drug shall strictly comply with relevant laws and regulations on advertisement administration. Contents of drug promotional material shall comply with the insert sheet of the drug approved by state drug administration departments.
Article 56: When inquiry, complaints, random checking or the sales process reveals quality problems, the cause of the problem shall be identified responsibility determined, effective measures adopted to remedy the situation. Appropriate records shall be kept.
Article 57: When a quality problem is discovered in a drug already sold, it shall be reported to relevant administration department, the drug duly recalled, and appropriate records shall be kept.
Chapter 3: Quality Control of Retail Drugs
Section 1: Management Duties
Article 58: A drug retail or retail chain enterprise shall do business according to an approved business model and scope, display in prominent places of the stores License for Drug Operations Enterprises, Business Licenses, and corresponding Practicing Certificates for its personnel.
Article 59: The chief responsible person of a retail enterprise shall assume the leadership responsibility position regarding the quality of drugs being sold.
Article 60: A retail enterprise shall establish a quality control department or assign special personnel responsible for quality control of the enterprise.
Article 61: A retail enterprise shall promulgate various rules of quality control according to relevant state laws, regulations, and this "GSP" based on the actual conditions of the enterprise. Periodic inspection and testing knowledge of the rules shall be conducted, and records shall be established.
Section 2: Personnel and Training
Article 62: Employee in a retail enterprise responsible for quality control shall possess professional titles in pharmacology.
Article 63: Personnel responsible for the evaluation of a prescription shall be a licensed pharmacist or possess professional technical titles above pharmacist (including pharmacist and TCM pharmacist).
Article 64: Employees of a retail enterprise responsible for quality control and drug inspection shall have educational background in pharmacology or related disciplines or possess professional titles in pharmacology.
Article 65: The employees of a retail enterprise responsible for acceptance, inspection, preservation, measurement, storage of drugs shall accept professional training and obtain professional certification before assuming relevant positions. Employees working in the positions for which the government has relevant qualification requirement shall have passed technical assessment and obtained required certificates before assuming the positions.
Article 66: A retail enterprise shall organize physical examinations for the employees who have direct contact with drugs in daily work and establish health files for them. Employees that are found to have contagious, psychiatric or other diseases that might contaminate drugs shall be immediately removed from positions which have direct contact with drugs.
Section 3: Facilities and Equipment
Article 67: A drug retail enterprise shall have a business site and warehouse commensurate with its business scale. The business site shall be bright, orderly, and free of any pollutants. The business site, warehouse and office area shall be separated.
Article 68: The business sites and warehouses of a drug retail enterprise shall be equipped with:
1. equipment to facilitate the display of drugs;
2. preservation equipment for drugs under special administration;
3. equipment that provide normal atmospheric temperature, cool or refrigerated conditions for the preservation of drugs according to relevant characteristics of drugs;
4. necessary equipment for inspection, acceptance inspection and preservation of drugs;
5. equipment to test and adjust temperature and humidity;
6. equipment to keep certain distance between drugs and the floor;
7. equipment to prevent dust, moisture, pollution, worm, rats, and mildew etc.; and
8. equipment to mix or prepare TCM according to a prescription.
Article 69: A drug retail chain enterprise shall set up a distribution center commensurate with its business scale. Its warehouse, inspection, acceptance and checking, preservation and other facilities shall be subject to the same requirements for a wholesale enterprise of the same scale. Drug display, preservation and other equipment for a chain store of a chain enterprise shall be subject to the same requirements as a retail store.
Section 4: Drug Procurement and Acceptance Inspection
Article 70: A retail enterprise shall purchase drugs from legitimate enterprises with the quality of drugs as top priority. The retail enterprise shall check the legality of a first-time supplier, and relevant records shall be kept.
Article 71: There shall be legitimate documentation (receipts, invoices and other documents) in purchasing drugs. Purchasing records shall be established according to relevant regulations to ensure that relevant documentation, account books and goods are consistent with each other. Purchasing records shall be maintained at least one year after the expiration of the concerned drugs, but in any event, not less than three years.
Article 72: Quality terms shall be explicitly stated in a procurement contract.
Article 73: Quality examination before sale shall be conducted when initially handling a drug.
Article 74: Acceptance inspection personnel shall strictly check the drugs purchased batch by batch according to relevant regulations and against the original documents. Relevant records shall be maintained. When necessary, samples may be taken and sent to inspection agencies.
Article 75: The packaging, labels, insert sheets and other items of drugs shall also be checked according to relevant regulations in the process of drug quality inspection.
Section 5: Display and Storage
Article 76: The quality and packaging of drugs on display at a retail store shall comply with relevant regulations.
Article 77: Drugs shall be displayed and stored according to classification, dosage forms, application, and storage requirements:
1. Drugs and non-drugs, internal use drugs and external use drugs shall be separately stored. Drugs with odors that might affect other drugs shall be stored separately from other drugs.
2. Drugs shall be stored according to relevant storage requirements regarding temperature and humidity.
3. Prescription and OTC drugs shall be displayed in separate cabinets.
4. Drugs under special administration shall be stored according to relevant regulations of the state.
5. Dangerous drugs shall not be displayed. If dangerous drugs must be displayed due to special needs, only substitutes or empty packages shall be used for display. Dangerous drugs shall be managed and stored according to relevant regulations of the state.
6. When the package of a drug is opened for retail sale, the drug shall be kept in special retail drug cabinet and the original label shall be kept.
7. The quality of a TCM preparation shall be checked and verified before it is put into drawers. Caution shall be taken to avoid putting drugs into the wrong drawer, mixing into other drawers or with other medicines. The front of a drawer of TCM preparations shall be marked with formal name of the drug in printed characters.
Article 78: Preservation work drugs stored or on display shall include:
1. Periodically checking the quality of drugs stored or on display and keeping records. Drugs that are near their expiration dates, or easy to mildew or deliquescere shall be checked more frequently. Samples of the drugs whose quality is in doubt or that have been stored for a long period of time shall be drawn duly taken for inspections.
2. Check whether the display environment and storage conditions meet relevant requirements.
3. Check on equipment of preservation.
4. Timely report problems detected to the quality control personnel for quality and handle the problem as soon as possible.
Article 79: Color coding shall be used to manage stored drugs.
Section 6: Sales and Service
Article 80: Drugs shall be sold according to relevant laws, regulations and rules. The functions, usage, contraindications and precaution of drugs shall be correctly noted.
Article 81: In drug sales, a prescription shall be evaluated by a licensed pharmacist or a person with professional title higher than pharmacist (including pharmacist and TCM pharmacist) before drugs can be prepared and sold. Drugs listed on the prescription shall not be arbitrarily changed or substituted. If a prescription contains drugs not compatible or with too high a dosage, the prescription shall not be filled and the drug not sold. If necessary, only after the original prescribing physician corrects or re-signs the prescription, may the drug be prepared and sold. The examiner and the person who prepares the drug or sales person shall co-sign or seal the prescription, which shall be filed according to relevant regulations for future checking.
Article 82: Tools used for opening drug package for retail sale and packaging bags shall be clean and hygienic. The drug name, specification, method of administration, dosage, expiration date and other items shall be marked on the packaging bags.
Article 83: The drugs under special management shall be supplied in limited quantities according to doctor's prescription which shall bear the seal of the medical institute. Both sales person and quality verification personnel shall all sign or seal on the prescription, which shall be kept on file for two years.
Article 84: A retail enterprise shall provide consulting services at the business retail site to provide customers with guidance on safe and reasonable drug administration. The enterprise shall also prepare a comments book for customers and a public telephone number for monitoring and duly resolve complaints and criticism from customer.
Chapter 4: Definitions
Article 85: Definitions of the terms in this "GSP":
The chief responsible person of an enterprise: refers to the legal person of an enterprise with legal person status; or the top level manager in an enterprise which does not have legal person status.
First-time Supplier: refers to a drug manufacturer or distributor with whom an operation enterprise has business relationship for the first time for drug purchase.
Initially handling a drug: refers to a drug purchased for the first time from a drug manufacturer by an operation enterprise.
Direct delivery of drugs: refers to the operation by which a drug enterprise directly deliver the drugs that it has purchased but not yet warehoused from the supplier to the buyer of the same drugs from the operation enterprise.
Prescription preparation: refers to the process of preparing and filling a prescription by a sales person.
Article 86: SDA shall be responsible for the promulgation of the working rules of this "GSP".
Article 87: SDA shall be responsible for the interpretation of this "GSP".
Article 88: This "GSP" shall be effective on July 1, 2000.