Section 4 Quality Management System Documents

Article 31 The quality management system documents formulated by enterprises shall conform to their actual situation. Documents include quality management system, departmental and post responsibilities, operating procedures, archives, reports, records and vouchers, etc.

Article 32 The drafting, revision, review, approval, distribution and retention as well as the amendment, revocation, replacement and destruction of documents, shall be conducted in accordance with the documentation control operating procedures, and relevant records shall be kept.

Article 33 Documents should have title, category, purpose, document number and version number. The words shall be accurate, clear and understandable.

Documents should be laid out by categories and be easy to check.

Article 34 Enterprises shall periodically review and revise the documents, and the documents used shall be current valid versions. Documents that have been abolished or invalid shall not appear on the work site unless they are kept for reference.

Article 35 Enterprises shall ensure that all posts have access to necessary documents corresponding to their work contents, and carry out their work in strict accordance with the provisions.

Article 36 The quality management system shall include the following contents:

(I) The provisions for internal audit of quality management system;

(II) The provisions for veto on quality;

(III) Management of quality management documents;

(IV) Management of quality information;

(V) Provisions on qualification of supplier, purchaser, sales personnel of supplier and purchasing personnel of purchaser;

(VI) Management of drug purchase, receiving, acceptance inspection, storage, maintenance, sales, ex-warehousing and transportation;

(VII) Provisions for drugs under special management;

(VIII) Management of the expiry date of drugs;

(IX) Management of unqualified drugs and drug destruction;

(X) Management of returned drugs;

(XI) Management of drug recalls;

(XII) Management of quality inquiry;

(XIII) Management of quality incidents and quality complaints;

(XIV) Provisions for reporting of ADRs;

(XV) Provisions for environmental health and personnel health;

(XVI) Provisions for quality-related education, training and assessment;

(XVII) Management of storage and maintenance of facilities and equipment;

(XVIII) Management of validation and calibration of facilities and equipment;

(XIX) Management of records and vouchers;

(XX) Computer system management;

(XXI) Provisions for the traceability of drugs;

(XXII) Other contents that need to be specified.

Article 37 Responsibilities of departments and posts shall include:

(I) Responsibilities of quality management, purchasing, storage, sales, transportation, finance and information management departments;

(II) Responsibilities of the responsible person of an enterprise, quality responsible person, and the responsible person of quality management, purchasing, storage, sales, transportation, finance and information management departments;

(III) Responsibilities of quality management, purchase, receiving, acceptance inspection, storage, maintenance, sales, ex-warehousing check, transportation, finance, information management and other posts;

(IV) Responsibilities of other posts related to drug distribution.

Article 38 Enterprises shall formulate operating procedures for the purchase, receiving, acceptance inspection, storage, maintenance, sales, ex-warehousing check and transportation of drugs and for the computer system.

Article 39 Enterprises shall establish records related to drug purchase, acceptance inspection, maintenance, sales, ex-warehousing check, return after sales and return after purchase, transportation, temperature and humidity monitoring during storage and transportation, and disposal of unqualified drugs and make them authentic, complete, accurate, effective and traceable.

Article 40 In case of recording data through a computer system, relevant personnel shall, in accordance with the operating procedures, enter or check the data only after they have been authorized and logged in with password. The change of data shall be reviewed by the quality management department and carried out under its supervision, which shall be recorded.

Article 41 Written records and vouchers shall be timely filled in with clear handwriting, and shall not be altered or torn at will. For a change of the records, reasons and date shall be indicated and signed, and original information shall be kept clear and legible.

Article 42 Records and vouchers shall be kept for at least 5 years. Records and vouchers of vaccines and drugs under special management shall be kept in accordance with relevant provisions.

Section 5 Facilities and Equipment

Article 43 Enterprises shall have business premises and warehouses adapted to their drug distribution scale and scope.

Article 44 The site selection, design, layout, construction, reconstruction and maintenance of warehouse shall meet the requirements for drug storage, so as to prevent the contamination, cross contamination, mix-ups and errors of drugs.

Article 45 Operating area for drug storage and auxiliary section shall be separated from office area and living quarters by some distance or there shall be isolation measures.

Article 46 The scale and conditions of a warehouse shall meet the requirements for reasonable and safe storage of drugs, and meet the following requirements to facilitate the storage operation:

(I) The internal and external environment of the warehouse is clean without pollutant source; and the ground of warehouse area is hardened or covered by vegetation;

(II) The warehouse has smooth interior walls and ceiling as well as flat floor with tight structure of door and window;

(III) There are reliable security measures in the warehouse, and controlled management may be carried out for the entrance of irrelevant personnel, preventing drugs from theft, replacement or mix-up with falsified drugs;

(IV) Protective measures against the impact of abnormal weather during outdoor loading and unloading, handling, receiving, shipment, and other operations shall be in place.

Article 47 A warehouse shall be equipped with the following facilities and equipment:

(I) The equipment for effective separation between drugs and the ground;

(II) The equipment for preventing light, moisture, insects and rats, as well as for ventilation;

(III) The equipment for effective control of temperature and humidity as well as that for indoor and outdoor air exchange;

(IV) The equipment for automatic monitoring and recording the temperature and humidity of the warehouse;

(V) The lighting equipment complying with the requirements for storage;

(VI) Operating areas and equipment for operation and double check of break bulk picking and LCL shipping;

(VII) Place for storing packaging materials;

(VIII) Special places for acceptance inspection, shipping and return of goods;

(IX) Special storage places for unqualified drugs;

(X) There shall be storage facilities conforming to national provisions for the drugs under special management.

Article 48 Enterprises engaged in Chinese crude drugs and Prepared Slices shall have special warehouses and workplaces for maintenance; those directly purchasing Chinese crude drugs at the place of production shall set up a sample room (cabinet) of Chinese crude drugs.

Article 49 Enterprises engaged in storage and transportation of refrigerated and frozen drugs shall be equipped with the following facilities and equipment:

(I) Freezer adapted to their business scale and varieties; for vaccines, two or more independent freezers shall be equipped;

(II) The equipment used for automatic monitoring, display, recording, control and alarm of the temperature in freezers;

(III) Standby generators or dual-circuit power supply system of refrigeration equipment in freezers;

(IV) For drugs with special requirements for low temperature, the facilities and equipment in accordance with their storage requirements shall be equipped.

(V) Refrigerated vehicles and vehicle-mounted refrigerated container or thermal insulation container and other equipment.

Article 50 Enclosed means of transport shall be used for the transportation of drugs.

Article 51 The refrigerated vehicle, vehicle-mounted refrigerated container or thermal insulation container for transportation of refrigerated or frozen drugs shall conform to the requirements for temperature control during the transportation of drugs. The refrigerated vehicle has the function of automatically controlling temperature, displaying temperature, storing and reading temperature monitoring data; the refrigerated container and thermal insulation container have the function of externally displaying and collecting the temperature data in the container.

Article 52 Personnel specially assigned shall be responsible for periodical inspection, cleaning and maintenance of the storage and transportation facilities/equipment, and records and archives shall be established.

Section 6 Calibration and Validation

Article 53 Enterprises shall periodically carry out calibration or validation on measuring instruments and temperature and humidity monitoring equipment in accordance with relevant national provisions.

The freezers, temperature and humidity monitoring systems of transportation & storage, as well as cold chain transportation facilities/equipment shall be validated by the enterprises prior to use, regularly and in case not in operation beyond the specified period.

Article 54 Enterprises shall form validation control documents in accordance with relevant validation management systems, including validation schemes, reports, evaluations, deviation handling and preventive measures, etc.

Article 55 Validation shall be carried out in accordance with the pre-determined and approved scheme; the validation report shall be reviewed and approved. Validation documents shall be archived.

Article 56 Enterprises shall correctly and reasonably use relevant facilities and equipment according to the parameters and conditions determined by validation.