Section 10 Storage and Maintenance

Article 83 Enterprises shall carry out proper storage of drugs according to their quality characteristics and conform to the following requirements:

(I) Drugs shall be stored in accordance with the temperature requirements indicated on the package. Where there is no specific temperature indicated on the package, the drugs shall be stored in accordance with the storage requirements stipulated in the Pharmacopoeia of the People's Republic of China;

(II) The relative humidity for the storage of drugs is 35%-75%;

(III) For the storage of drugs in the manually operated warehouse, color code management shall be carried out according to the status of the quality. Qualified drugs shall be in green, unqualified drugs shall be in red, and drugs to be determined shall be in yellow;

(IV) For the storage of drugs, measure shall be taken as required, such as preventing light, moisture, insects and rats and maintaining ventilation;

(V) Drugs shall be carried and stacked strictly following the requirements on package identifications, and stacking height shall conform to the requirements graphically displayed on the package, to avoid damaging the drug package;

(VI) Drugs shall be stacked according to lot numbers. Drugs with different lot numbers shall not be stacked together. The distance between the stacks shall be no less than 5 cm, and that from the stacks to the inner walls, ceiling, temperature control equipment and pipelines of the warehouse shall be no less than 30 cm, and that from the stacks to the ground shall be no less than 10 cm;

(VII) Drugs and non-drugs, drugs for topical use and other drugs shall be stored separately, and Chinese crude drugs and Prepared Slices shall be stored separately;

(VIII) Drugs under special management shall be stored in accordance with relevant national provisions;

(IX) Break-bulk drugs whose outer packages have been removed shall be stored in a centralized manner;

(X) Facilities and equipment for the storage of drugs such as shelves and trays shall be kept clean without damage or stacking of sundries;

(XI) The unapproved personnel shall not enter the storage area, and the personnel in storage area shall not have any action affecting the quality and safety of drugs;

(XII) Items irrelevant to storage management shall not be stored in the storage area of drugs.

Article 84 Maintenance personnel shall maintain drugs according to warehouse conditions, external environment, and quality characteristics of drugs, which shall include the following main contents:

(I) Guiding and urging the storage personnel to store and operate the drugs in a reasonable manner;

(II) Checking and improving the storage conditions, preventive measures and sanitary environment;

(III) Effectively monitoring and controlling the temperature and humidity in the warehouse;

(IV) Checking the appearance, packaging and other quality status of the drugs in inventory according to the maintenance plan and establishing the maintenance records; varieties with special requirements for storage or with short expiry date shall be subject to key maintenance;

(V) Any drug identified with suspicious issues shall be locked and recorded in the computer system in time and notified to the quality management department for disposal;

(VI) The Chinese crude drugs and Prepared Slices shall be maintained with effective methods according to their characteristics, which shall be documented. The maintenance methods adopted shall cause no contamination to the drugs;

(VII) Summarizing and analyzing maintenance information regularly.

Article 85 Enterprises shall use the computer system to automatically track and control the expiry date of drugs in inventory, adopt measures such as early alarm for those approaching expiry date and automatically lock for those beyond expiry date to prevent the sales of expired drugs.

Article 86 In case of leakage of liquid, gas or powder due to breakage of drugs, safe handling measures shall be taken promptly to prevent contamination to the storage environment and other drugs.

Article 87 For drugs likely to have quality issues, measures of suspending the sales shall be taken immediately, and the drugs shall be locked in the computer system and reported to the quality management department for confirmation. With respect to drugs with quality issues, the following measures shall be taken:

(I) Such drugs shall be stored in special places clearly marked and effectively isolated, and shall not be sold;

(II) Any suspected falsified drug shall be in a timely manner reported to the food and drug regulatory department;

(III) Drugs under special management shall be handled in accordance with the relevant national provisions;

(IV) The handling process of unqualified drugs shall have complete procedures and records;

(V) For unqualified drugs, reasons shall be identified and analyzed, and preventive measures shall be taken in time.

Article 88 Enterprises shall periodically carry out inventory check of drugs and ensure consistency between the accounts and goods.

Section 11 Sales

Article 89 Enterprises shall sell drugs to legal purchasers and validate the certificates of the purchasers and the identity certificates of the purchasing personnel and the pickup personnel, so as to ensure that the flow of drug sales is authenticate and lawful.

Article 90 Enterprises shall strictly audit the production scope, business scope or diagnosis and treatment scope of the purchasers, and sell drugs in accordance with the corresponding scope.

Article 91 Invoices shall be truthfully issued for drugs sold by enterprises, ensuring the consistency among invoice, accounts, goods and amount.

Article 92 Enterprises shall take records of drug sales. Sales records shall include the adopted name, strength, dosage form, lot number, expiry date, manufacturer, purchaser, sales quantity, unit price, amount and sales date of the drug. Special sales records shall be established for the direct transfer of drugs in accordance with Article 69 herein.

The sales records of Chinese crude drugs shall include the name of the product, strength, place of production, purchaser, sales quantity, unit price, amount and sales date; those of Prepared Slices shall include the name of product, strength, lot number, place of production, manufacturer, purchaser, sales quantity, unit price, amount and sales date, etc.

Article 93 The sales of drugs under special management and those with special management requirements of the State shall be carried out in strict accordance with the relevant national provisions.

Section 12 Ex-warehousing

Article 94 For the ex-warehousing, the drugs shall be checked against the sales records. In case of the following situations identified, ex-warehousing shall not be allowed and such situations shall be reported to the quality management department for handling:

(I) There is damage, contamination, poor sealing, poor packaging cushion, or damaged seal on the package of drugs;

(II) Abnormal noise or liquid leakage in the package;

(III) There is falloff of labels, vague handwriting or labeling not matching with material object;

(IV) The drug has been expired;

(V) Drugs with other abnormalities.

Article 95 Records shall be established for ex-warehousing check of drugs, including the purchaser, adopted name, dosage form, strength, quantity, lot number, expiry date, and manufacturer of drugs, ex-warehousing date, quality status and checker, etc.

Article 96 The ex-warehousing of drugs under special management shall be double checked in accordance with relevant provisions.

Article 97 For LCL shipping of drugs, substituted packaging box shall have clear mark of LCL.

Article 98 At the time of ex-warehousing of drugs, the accompanying sheet (bill) stamped with the original special seal for drug ex-warehousing of enterprises shall be attached.

Where an enterprise directly transfers drugs in accordance with Article 69 herein, the supplier shall issue two copies of the same accompanying sheet (bill) at the time of ex-warehousing of the directly transferred drugs which shall be respectively sent to the directly transferring enterprise and the purchaser. The contents of the accompanying sheet (bill) shall comply with the requirements of Paragraph 2 of Article 73 herein and also indicate the name of the directly transferring enterprise.

Article 99 Specially-assigned personnel shall be responsible for the operations such as packaging and loading of refrigerated or frozen drugs, which shall conform to the following requirements:

(I) Vehicle-mounted refrigerated container or thermal insulation container shall meet relevant requirements for temperature before use;

(II) Packaging and sealing of refrigerated or frozen drugs shall be completed in refrigerated environment;

(III) The startup and operation status of refrigerated vehicle shall be checked before loading. Loading shall not be conducted until the specified temperature is reached;

(IV) At the time of departure, transportation records shall be made, including means of transport and time of departure, etc.

Section 13 Transportation and Dispatch

Article 100 Enterprises shall strictly implement the transportation operating procedure in accordance with the requirements of the quality management system and take effective measures to ensure the quality and safety of drugs during transportation.

Article 101 For the transportation of drugs, appropriate means of transport shall be selected in light of the packaging and quality characteristics of the drugs and according to such factors as vehicle conditions, roads and weather, and corresponding measures shall be taken to prevent damage and contamination.

Article 102 At the time of shipment of drugs, the means of transport shall be examined. If the transportation conditions are identified to be not in conformity with the provisions, the drugs shall not be shipped. During the transportation of drugs, the means of transport shall be kept airtight.

Article 103 Enterprises shall carry, load and unload drugs in strict accordance with the requirements on the outer package.

Article 104 Enterprises shall take necessary measures for heat preservation, or refrigeration and freezing during transportation in accordance with the temperature control requirements of drugs.

In the process of transportation, drugs shall not be in direct contact with the ice bags, ice raft and other coolants to prevent their impacts on the quality of drugs.

Article 105 During the transportation of refrigerated or frozen drugs, real-time monitoring and recording of temperature data in refrigerated vehicles, refrigerated container or thermal insulation container shall be conducted.

Article 106 Enterprises shall formulate a contingency plan for the transportation of refrigerated and frozen drugs, and be able to take corresponding measures to deal with such emergencies as equipment failure, abnormal weather influence and traffic congestion that may occur during the transportation.

Article 107 Where an enterprise entrusts another entity to transport drugs, it shall audit the quality assurance capability of the carrier for the transportation of drugs and request relevant information of the transportation vehicle, and the entrustment shall be made only if it meets the conditions and requirements for transportation facilities and equipment as specified in the GSP.

Article 108 In case of entrusted transportation of drugs, enterprises shall sign a transportation agreement with the carriers to specify the responsibility for the quality of drugs, the compliance with the transportation operating procedure and the time-in-transit, etc.

Article 109 The entrusted transportation of drugs by enterprises shall be recorded so as to realize quality traceability in the process of transportation. Records shall at least include shipping time, shipping address, consignee, receiving address, bill of lading number, quantity of drugs, mode of transportation, entrusted agent and carrier. When adopting vehicle-based transportation, the license plate number shall be clearly stated, and a copy of the driving license of the driver shall be retained. Records shall be kept for at least 5 years.

Article 110 The loaded drugs shall be shipped in time and delivered as soon as possible. In case of entrusted transportation, enterprises shall require and supervise the carriers to strictly fulfill the agreement on entrusted transportation so as to prevent the quality of drugs from being affected by the long time-in-transit.

Article 111 Enterprises shall take measures for transportation safety management to prevent theft, robbery, loss and exchange of drugs in the course of transportation.

Article 112 The transportation of drugs under special management shall comply with the relevant national provisions.

Section 14 After-sales Management

Article 113 Enterprises shall enhance the management of sales return, ensure the quality and safety of drugs in the process of sales return, and prevent from mixing with falsified drugs.

Article 114 Enterprises shall formulate the operating procedure for complaint management according to the requirements of quality management system, which shall include complaint channels and means, file records, investigation and evaluation, handling measures, feedback and follow-ups.

Article 115 Enterprises shall be equipped with full-time or part-time personnel responsible for complaint management. For the quality issues pertinent to complaints, identify the reasons, take effective measures to handle and feedback in time, take records, and notify suppliers and drug manufacturers when necessary.

Article 116 Enterprises shall in a timely manner record the information including complaints and results of handling in the file for the purpose of inquiry and tracing.

Article 117 In case of identifying a sold drug with serious quality issues an enterprise shall immediately notify the purchaser to stop the sale, retrieve the drug, take records and report to the food and drug regulatory department.

Article 118 Enterprises shall assist drug manufacturers in implementing the recall obligation, transmit information and provide feedback on recall of drugs and control and withdraw drugs with safety hazards according to the requirements of the recall plan, and establish the recall record of drugs.

Article 119 The quality management department of an enterprise shall be equipped with full-time or part-time personnel to undertake ADR monitoring and reporting in accordance with relevant national provisions.