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What are the requirements of the gmp specifications for pharmacy retail enterprises

2026-07-20 13:41
2026-07-20 17:25

The following requirements are set in the drug store retail enterprise's GPS: 1. ** In terms of operating according to laws and regulations ** - They shall engage in business activities in accordance with the business methods and business scope approved by law. - The main person-in-charge of the enterprise is responsible for the quality of the drugs sold by the enterprise. - If the drug trading license is within the period of validity, the drug trading enterprise license, business license, and practice certificate that meets the requirements of the practitioners shall be hung in a prominent position in the business hall. 2. ** Quality Management Organization and Personnel ** - A quality management organization or full-time quality management personnel shall be set up to be responsible for the quality management of the enterprise, including the implementation of national laws, regulations and administrative rules on drug quality management, such as drafting the drug quality management system of the enterprise, guiding and supervising the implementation of the system; responsible for the quality review of the first-run enterprises and first-run varieties; establishing the quality files of the drugs sold by the enterprise, including the quality standards; To be responsible for inquiring about the quality of drugs and investigating, handling and reporting on drug quality accidents or complaints; to be responsible for the management of drug acceptance; to be responsible for guiding and supervising the quality work in the storage, maintenance and transportation of drugs; to be responsible for the review of unqualified drugs and supervising the handling process of unqualified drugs; to be responsible for collecting and analyzing drug quality information; to assist in the education or training of drug quality management for the enterprise employees. - The person in charge of quality management in large and medium-sized enterprises should have the technical title of pharmacist (including pharmacist and traditional Chinese medicine master) or above; the person in charge of quality management in small enterprises should have the technical title of pharmacist (including pharmacist and traditional Chinese medicine master) or above. 3. ** Quality Management System ** - It is necessary to formulate the quality responsibilities of relevant businesses and management posts; regulations on the purchase, acceptance, storage, display, and maintenance of drugs; regulations on the review of first-run enterprises and first-run varieties; regulations on drug sales and prescription management; regulations on the management of disassembled drugs; regulations on the purchase, storage, safekeeping, and sales of specially-controlled drugs; regulations on the handling and reporting of quality accidents; regulations on the management of quality information; regulations on the reporting of adverse drug reactions; and various hygiene management systems; The management regulations on the health status of the personnel, the management regulations on the service quality, and the quality management system that meets the regulations on the purchase, sales, and storage of the Chinese herbal pieces should be established for the enterprises that operate the Chinese herbal pieces. - All management systems should be checked and assessed regularly, and records should be established. 4. ** Purchasing and management ** - The Purchasing Department should carefully screen the suppliers and commodities, and the Quality Management Department should carefully do a good job in the first business enterprise and the first business variety review. Only the qualified suppliers that have been approved by the Quality Management Department of the enterprise are qualified to supply the enterprise. They are not allowed to purchase drugs from the unapproved suppliers. Only the qualified products that have been approved by the Quality Management Department can be purchased by the purchasing staff. If they have not passed the review, the purchasing staff is not allowed to purchase without authorization. - Sell and store drugs at the address approved by the drug administration department in accordance with the business method and business scope stated in the drug business license, operate in good faith according to laws and regulations, and establish a drug tracing system to ensure that the entire process of drug distribution can be traced back and not beyond the scope of business. - Pharmacies that deal in anesthetics, Class I psychotropics, and precursor chemicals should be inspected twice or more each year, one of which should be the inspection of drug compliance with GPS; It operates chilled and frozen drugs, second-class psychiatric drugs, medical toxic drugs companies, and pharmaceutical third-party logistics companies (Including the third-party logistics management of drugs) and their business sites should be inspected once or more every year, and at least once in three years should be the inspection of drug GPS compliance. The inspection should cover no less than one-third of the relevant business sites or at least five storage and distribution sites. The drug supervision and administration department will also select a certain proportion of enterprises to carry out drug GPS compliance inspection every year. In addition, all drug trading enterprises in the administrative region will be inspected within three years. Read more exciting novels for free

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2026-10-19 03:59
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