Section 7 Computer System

Article 57 Enterprises shall establish a computer system meeting the requirements for the whole-course management of distribution and quality control, achieving the traceability of drugs.

Article 58 The computer system of enterprise shall meet the following requirements:

(I) Server and terminal supporting the normal operation of the system;

(II) Safe and stable network environment, fixed mode for accessing the Internet, and safe and reliable information platform;

(III) LAN for information transmission and data sharing between departments and posts;

(IV) Functions of generating, printing and managing the bills of drugs-related business;

(V) Application software and relevant database meeting the requirements of the GSP and the actual needs of enterprise for management.

Article 59 The operations such as input, modification and saving, etc. of various data shall meet the requirements for the scope of authorization, operating procedures, and management system and ensure the originality, authenticity, accuracy, security, and traceability of the data.

Article 60 The data concerning enterprise's operation and management in the operation of the computer system shall be saved in a secure and reliable way and backed up on a daily basis. Backup data shall be stored in a secure place. The storage duration of recorded data shall meet the requirements of Article 42 herein.

Section 8 Purchase

Article 61 Purchase activities of an enterprise shall meet the following requirements:

(I) Determine the legal qualification of supplier;

(II) Determine the legality of the drugs purchased;

(III) Validate the legal qualification of sales personnel of supplier;

(IV) Sign a quality agreement with the supplier.

For the first commercial enterprise or first commercial variety involved in the purchase, the purchasing department shall fill in relevant application forms, which shall be reviewed and approved by the quality management department and the quality responsible person of an enterprise. If necessary, field investigation shall be organized to evaluate the quality management system of the supplier.

Article 62 For the review of first commercial enterprise, the following materials stamped with its official seal shall be checked to confirm their authenticity and validity:

(I) A copy of the Drug Manufacturing Certificate or Drug Distribution Certificate;

(II) Copies of business license, tax registration and certificate of organization code, and the publicity of the annual report of the enterprise in the previous year;

(III) A copy of the Certificate of Good Manufacturing Practice or Certificate of Good Supply Practice for Drugs;

(IV) Model of relevant seal and the accompanying sheet (bill);

(V) Account name, bank name and account number.

Article 63 For the purchase of first commercial variety, the legality of the drugs shall be validated, and copies of the Drug Manufacturing Certificate or Import License of the drugs stamped with the official seal of the supplier shall be requested and reviewed. The purchase shall be made only for those qualified in the review.

The above data shall be incorporated in the quality archives of drugs.

Article 64 Enterprises shall validate and retain the following information about the sales personnel of supplier:

(I) A copy of the ID card of sales personnel stamped with the official seal of supplier;

(II) A power of attorney stamped with the original seal of supplier and the seal of or signed by the legal representative of supplier, which shall indicate the name and ID card number of the authorized person, as well as the varieties, region and time limit authorized for sale;

(III) Information related to the supplier and the varieties to supply.

Article 65 The quality agreement signed by the enterprise and the supplier shall at least include the following contents:

(I) Clarify quality responsibilities of both parties;

(II) The supplier shall provide materials meeting the provisions and bear responsibilities for their authenticity and validity;

(III) The supplier shall issue invoices in accordance with national provisions;

(IV) The quality of drugs shall comply with relevant requirements such as drug standards;

(V) The package, label and package insert of drugs shall comply with relevant provisions;

(VI) Quality assurance and responsibility for drug transportation;

(VII) Expiry date of the quality agreement.

Article 66 For the purchase of drugs, enterprises shall request invoices from suppliers. The invoice shall state the adopted name, strength, package unit, quantity, unit price and amount of the drug. If the items cannot be listed in full, the List of Goods Sold or Provision of Taxable Services shall be attached, with the original special invoice seal of the supplier stamped and the number of tax receipt marked.

Article 67 The name of the purchaser or supplier, the amount and the name of the product on the invoice shall be consistent with the flow, the amount and the name of the product of payment, and correspond to the contents of financial accounts. Invoices shall be kept in accordance with relevant provisions.

Article 68 Purchase records shall be established for drugs purchased. Purchase records shall include the adopted name, dosage form, strength, manufacturer, supplier, quantity, price and date of purchase, etc. The place of production shall also be indicated for Chinese crude drugs and Prepared Slices.

Article 69 In case of special situations such as disasters, epidemic, emergencies or clinical emergency treatment, and other circumstances in conformity with the relevant national provisions, enterprises can purchase and sell drugs by means of direct transfer, and the drugs purchased will not be put into their own warehouse, but directly sent from the supplier to the purchaser. Special purchase records shall be established to ensure effective quality tracking and tracing.

Article 70 The purchase of drugs under special management shall be conducted in strict accordance with the relevant national provisions.

Article 71 Enterprises shall regularly conduct comprehensive quality review on the overall situation of drug purchase, establish the archives of drug quality review and quality archives of suppliers, and conduct dynamic tracking management.

Section 9 Receipt and Acceptance Inspection

Article 72 Enterprises shall, in accordance with the prescribed procedures and requirements, receive and inspect the arrived drugs lot by lot, so as to prevent unqualified drugs from being warehoused.

Article 73 Upon arrival of drugs, the receiving personnel shall validate whether the mode of transportation meets the requirements, and check the drugs against the accompanying sheet (bill) and the purchase records to ensure consistency among bills, account and goods.

The accompanying sheet (bill) shall include the supplier, the manufacturer, the adopted name, dosage form, strength, lot number and quantity of drugs, the consignee, receiving address, shipping date and other contents, and stamped with the original special seal for drug ex-warehousing of the supplier.

Article 74 Upon arrival of refrigerated and frozen drugs, the inspection shall focus on the status of quality control over the means of transportation, temperature record during the transportation, and transportation time, records shall be taken, and those failing to meet temperature requirements shall be rejected.

Article 75 For drugs conforming to receipt requirements, the receiving personnel shall place them in the corresponding area for quarantine according to the characteristics and requirements of the varieties, or set status identification, and notify relevant personnel for acceptance inspection. The refrigerated and frozen drugs shall be placed in the freezer for quarantine.

Article 76 For acceptance inspection of drugs, the inspection report of the same lot number shall be checked according to the lot number of the drug. Where the supplier is a wholesale enterprise, the inspection report shall be stamped with its original special seal for quality management. The transmission and retention of inspection reports may be in the form of electronic data, but their legality and validity shall be guaranteed.

Article 77 Enterprises shall carry out sampling inspection for acceptance lot by lot for drugs of each arrival in accordance with the provisions on acceptance inspection, and the samples taken shall be representative:

(I) At least one minimum package of the drug shall be inspected for drugs with the same lot number. However, the minimum package may not be opened if the manufacturer has special quality control requirements or if the opening of the minimum package may affect the quality of the drug;

(II) In case of abnormal packaging, such as damage, contamination, leakage, or damaged seals, as well as break-bulk cargo or LCL, inspection shall be carried out to the minimum package;

(III) Active drug ingredients with intact outer package and seal, and biological products subject to lot release management may not undergo out-of-box audit.

Article 78 Acceptance inspection personnel shall inspect and check the appearance, package, label, package insert and relevant supporting documents of the sampled drugs one by one; after the acceptance inspection, the intact samples taken shall be put back into the original packaging box, sealed and marked.

Article 79 Drugs under special management shall be checked and inspected in special warehouses or special areas in accordance with relevant provisions.

Article 80 Acceptance inspection records shall be taken for drugs under acceptance inspection, including adopted name, dosage form, strength, approval number, lot number, date of production, expiry date, manufacturer, supplier, quantity of arrival, date of arrival, quantity qualified in acceptance inspection and results of acceptance inspection of drugs, etc. The acceptance inspection personnel shall sign his/her name and indicate the date on the acceptance inspection record.

Acceptance inspection records of Chinese crude drugs shall include the name of the product, the place of production, the supplier, the quantity of arrival, and quantity qualified in acceptance inspection, etc. Acceptance inspection records of Prepared Slices shall include the name of the product, strength, lot number, place of production, date of production, manufacturer, supplier, quantity of arrival and quantity qualified in acceptance inspection, etc. For Prepared Slices subject to the management of approval number, the approval number shall also be recorded.

For those failed in the acceptance inspection, nonconformance and handling measures shall also be specified.

Article 81 Enterprises shall keep inventory records, and in a timely manner warehouse and register the drugs that are qualified in the acceptance inspection; those failed in the acceptance inspection shall not be warehoused and shall be instead handled by the quality management department.

Article 82 Where an enterprise directly transfers the drugs in accordance with Article 69 herein, it may entrust the purchaser to conduct drug acceptance inspection. The purchaser shall conduct acceptance inspection on the drugs in strict accordance with the GSP and establish special acceptance inspection records for the directly transferred drugs. On the day of acceptance inspection, relevant information of acceptance inspection records shall be transmitted to the directly transferring enterprise.