2013.03.15 ZHANG, Wei、Zhang Dayin
Good Supplying Practices are the basic standards of the operation, management and quality control of drug distribution enterprises. The new Good Supplying Practices (published as Order No. 90 by the Ministry of Health, the “Revised GSP”) which was promulgated on January 22, 2013, will take effect as of June 1, 2013, and will supersede the current Good Supplying Practices adopted by the State Food and Drug Administration (“SFDA”) on April 30, 2000. Compared to the current standards, the Revised GSP contains more administrative provisions, which will substantially help strengthen the criteria of quality control and the thresholds of market entry.
I. Framework of Revised GSP
The Revised GSP was issued with a definite target of “fully promoting one administrative method, strengthening two key links and resolving three tough issues”. “One administrative method” refers to the implementation of computer information management system for enterprises; “two key links” refers to drug purchase-sales channels and temperature and humidity control for warehouses; and “three tough issues” refers to voucher management, cold chain management and drug transportation.
The Revised GSP comprises of four chapters, namely the General Provisions, Quality Control for Drug Wholesale, Quality Control for Drug Retail, and Supplementary Provisions, totaling 187 articles.
II. Scope of Application of Revised GSP
The Revised GSP applies to drug distribution enterprises (including wholesalers and retailers). And as provided for in the Revised GSP, “any drug manufacturing enterprises selling drugs, or engaging in storage or transportation of drugs during the circulation process shall also observe the relevant requirements hereof”. The Revised GSP does not apply to (a) the pharmacies in medical institutions and family planning service providers in terms of the quality control of drug purchase, storage and maintenance, and (b) online drug sales in terms of quality control, the relevant regulations will be formulated by the SFDA separately.
III. Major Revisions Made
Enhanced Criteria and Requirements on Software and Hardware of Drug Distribution Enterprises
In respect of software, enterprises are required to establish a quality management system. The Revised GSP sets forth the detailed requirements for the establishment of department of quality management or the provision of personnel in charge of quality management and the documentation related thereto, and enhances the qualification criteria for the personnel in the positions of person in charge of the enterprise, person in charge of product quality, person in charge of the quality management department, and staff working for departments of quality management, inspection and acceptance and maintenance.
In respect of hardware, enterprises are required to adopt the computer informationized management with a focus on the functional requirements of the facility, network environment, database and application software used in the computer management; enterprises are further required to use automatic temperature and humidity monitor for drug warehouses in order to conduct consistent and effective real-time monitoring on the environment therein, and are equipped with certain equipments or facilities for storage and transportation of refrigerated or frozen drug.
Certain New Rectification Mechanism Adopted
With respect to such issues as the non-standardized drug distribution activities, unclear purchase and sales channels, and disordered voucher management, the Revised GSP explicitly requires that the sales and purchase transactions be furnished with sales invoices, drug delivered from storage and in transit be accompanied by the list of goods which is to be checked upon delivery, and the vouchers, accounts and goods shall conform to each other during the logistic activities.
Enterprises are required to check and review if entrusted carriers have the transportation capacity and relevant quality assurance capability, enter into an agreement containing liabilities for breach of contract, and track by recording the quality of goods during the transportation.
The Revised GSP particularly strengthens the requirements on the equipments and facilities for storage and transportation of cold chain drug, with a special requirements on the handover processes, temperature monitor as well as trace and inspection for the transportation, goods receiving, and other links for the cold chain medicine, and put forward higher standard for the quality assurance capability of high-risk varieties.
The Revised GSP further requires drug distribution enterprises establish a system for enforcing the electronic monitoring for drugs, contains specific requirements as to such operations as code scanning and data uploading during the process of inspection and stock-in, stock-out, and sales of drugs and as to that the legal representative or person in charge of the drug retailers be professional pharmacists. Each drug retailer is required to engage licensed pharmacist according to relevant state regulations, who shall be in charge of review and verifying prescriptions and providing guidance for rational drug use.
IV. Formulation and Implementation of Relevant Supporting Documents
The Revised GSP mainly provides for the basic guidelines for the drug distribution management and quality control, with the specific rules on the technical, professional and operation requirements during the drug distribution management process, such as computer systems, temperature and humidity monitoring system for warehouses, acceptance and inspection for drugs, storage and transportation for refrigerated and frozen drugs, among others, will be formulated by SFDA as appendices to the Revised GSP for implementation.
V. Three-year Transition Period
SFDA sets forth a three-year transition period for the implementation of the Revised GSP. By such deadline in 2016, any enterprises failing to meet the criteria as provided in the Revised GSP will be ordered to cease its drug distribution operations. The detailed implementation guidelines are to be promulgated by SFDA.
