Brief Introduction of Current GSP and Discussion of Changes in the New Edition of GSP

ZHAO Shuang-chun, CHEN Yu-wen ZHAO Hong-ju

(1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Center for Certification of Drug, Shenyang 110003, China)

Brief Introduction of Current GSP and Discussion of Changes in the New Edition of GSP

ZHAO Shuang-chun1,2, CHEN Yu-wen1, ZHAO Hong-ju2

(1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2.Center for Certification of Drug, Shenyang 110003, China)

Objective To introduce the current GSP, and to discuss the changes in the new edition of GSP. Methods Documents analysis and regulation studies were used to study the current GSP and the changes in the new edition of GSP. Results and Conclusion The added contents of the new edition of GSP are conducive to the quality of drugs.

GSP; quality management; supply chain

1 Overview of GSP

1.1 The definition of GSP

GSP is short for Good Supply Practice, it controls all the possible factors that may damage the intermediate links, thus it is a complete set of management procedure which prevents quality accidents.

The current GSP was issued by the former SFDA in April 30, 2000, and was carried out since July 1, 2000. It is an significant compulsory administrative regulation. On September 16, SFDA issued “enforcement regulation of GSP” in order to specify some clauses that are not clearly defined in GSP.

1.2 Brief introduction on current GSP

Current GSP has 4 chapters that can be divided into 14 sections. Its core contents include premise, personnel qualifications, quality management, procedure and file management system.

General rules for the first chapter of GSP explains the legal basis of GSP, the requirement for the drug distributors and its scope of application.

The second chapter of GSP specifies the quality management of pharmaceutical wholesaler, such as the management personnel and the whole process of business operation, which include quality management, training of personnel, premises, purchases, acceptance; storage curing, outbound transportation, sales and after-sales service.

The third chapter of GSP is about the quality management of pharmaceutical retail. It specifies the management personnel and the whole process of business operation, which also include the same items mentioned in chapter 2.

The fourth chapter of GSP is the supplementary provisions, it specifies the definition of key terms and the regulations shall be interpreted by SFDA.

2 The prospective view of new edition of GSP

In August 1, 2011, the SFDA released notification on the revision of new edition about GSP. It required units at all levels should organize local FDA and companies to study the new edition of GSP and submit opinions and suggestions.

In February 22, 2013, the SFDA issued the new edition of GSP (Number 90 by the Health Ministration), it shall be carried into effect from June 1st, 2013. The new edition of GSP has 4 chapters which contain 187 clauses, it includes general rules, the quality management of drug wholesaler and the quality management of drug retailer. The issue of this new edition is a big adjustment in our supervision policy of drugs distribution, and it is a promotion on the situation of business operation and the requirement of regulations. Compared with current regulation, the new edition of GSP dramatically improvesquality management, and effectively enhances the control ability of quality risk about drug circulation.

The contents of new edition of GSP:

(1) It increases the management of cold chain system. In order to ensure the seamless connection between GMP and GSP, it standardizes the whole process of drug supply chain and extends the quality control of GMP, and eventually keeps in line with the specification of medical institutions. For instance, article 107 requires companies to take necessary measurements in transit, such as heat preservation, refrigeration or freezing etc.

(2) It strengthens the information construction. For instance, article 7 in chapter 4 specifies the use of computer system, and it regulates computer system configuration and network management operation. Enterprises should establish a computer system which can meet the need of the whole business management process on quality control. Therefore, the quality of drugs can be traced and satisfy the condition for implementation of drug electronic supervision.

(3) It increases the risk management. The new GSP adds some risk management to the contents, emphasizing that the risk management should run though the whole product life cycle. According to this method, the business management should keep an eye on every link of the supply chain, eliminating blind spots and broken chain phenomenon in quality control.

(4) It strengthens the management of notes. The new edition of GSP strengthens the management of procurement bills. For instance, article 66 stipulates that enterprises should seek for invoice from the suppliers when conducting the purchase of drugs. The invoice should specify the name of the drug, specification, units, quatity, unit of drug prices, and amount, etc.

3 Comparison and analysis of the major changes

3.1 Personnel qualification

The new edition of GSP improves personnel qualification requirements, such as the key quality management person should have bachelor degree or above, a pharmacist’s license and at least 3 years work experience in pharmaceutical business and quality management.

Personnel is the guarantee of the conduction of quality management，the new edition of GSP increases personnel quality requirement and it would be beneficial to the implementation of quality management.

3.2 Quality management system files

The new edition increases requirements on the documents of quality system, which specifies that enterprises should establish quality management system, department and job responsibilities, procesures, records, reports and documents and so on.

Enterprises should ensure that personnel can operate in accordance with quality management system and job responsibilities to achieve qualtiy target. So, enterprises must have a sound quality management system file and train their personnel to conduct quality management.

3.3 Facilities

The new edition increases requirements on the cold storage in transportation, such as the refrigerated truck, car freezer and heat insulation box which should be in consistent with the requirement for temperature control. The refrigerated vehicles should contain auto temperature control system which can show and record temperature; the refrigerated container and heat insulation box should have an external display which will show and collect the internal temperature data.

The cold chain management system is a new content in GSP. By regulating the cold chain system we can achive the goal of quality transportation and to guarentee the drug quality for further use.

3.4 Acceptance and inspection

The new edition of GSP regulates that we should check the drug test report in accordance with the drug batch number. The report should have original seal of quality management if the suppliers are wholesalers. The delivery and storage of reports could adopt electronic data form if it can guarantee its legitimacy and effectiveness. In the meantime, it regulates that if the suppliers do not seal or stick to the Chinese medicine electronic regulatory code, or the code does not comply with regulation, the medicine should be rejected.

Acceptance inspection is the key to ensure the legitimacy and quality of drug purchase. The new edition of GSP increases the requirements on checking electronic code by quality management department, thus it is conducive to drug quality management and traceability.

3.5 Application of computer systems

The new edition of GSP refers to the application of computer systems, for instance, the enterprises shouldestablish a computer system to meet the need of quality control so that enterprises can trace medicine quality and satisfy the medicine electronic data supervision. The enterprises should apply the computer system to automatically tracing and controlling the validity of drugs in storage. Some measurements, such as early warning the validity and automatically locking the drugs that exceed the validity can be taken to prevent the sale of expired drugs.

The establishment of computer system helps to improve the efficiency of quality management, which is vital for large enterprises. So, enterprises can rely on computer system to improve the quality of mangement.

3.6 Drug recall

Recall means the manufactures should recall their drugs which have hidden problems in the markets according to the established procedures, SFDA issued the Drug recall management approach in 2007. The new edition of GSP regulates that enterprises should help pharmaceutical manufactures to conducts the obligation of drug recall, they should deliver and get feedback the information of drug recall, and they should control and recover the drugs with hidden problems and set up the drug recall record as well.

The drug distributors should establish a recall system, which specifies the members who conduct the drug recall and the procedure in order to provide help for the manufacturers and governments to perform drug recalls effectively. This system can ensure the safety of medication.

4 Summary

GSP is the basic principle for enterprise management and quality control. The former GSP has played an important role in promoting the quality of drug business, standardizing business behavior and ensuring the safety of medication since 2000. But with the rapid economic and social development, the former GSP could not meet the requirement of drug circulation and supervision. The new edition of GSP has adapted to the requirement of the times, and brought all the relevant factors that may affect the quality of drugs into the regulations, which can ensure the quality of drugs.

The new edition of GSP formally became effective from June 1st, 2013. The industry is facing big challenges, more than half of whole sellers and retail business will be eliminated, the enterprises should invest more to improve quality management system in order to comply with the new edition of GSP, it will enhance the concentration ratio of our industry and increase the speed of merger integration which can improve the product quality.

[1] Chen Yu-wen. Practical Drug GSP Implementation Technology [M]. Beijing: Chemical Industry Press, 2004: 1-2.

[2] Good Sales Practice (Number 20 by SFDA) [EB/OL]. http://www. sfda.gov.cn/WS01/CL0053/19419.html. 2000-04-30.

[3] Good Sales Practice (Number 90 by MOH) [EB/OL]. http://www. sfda.gov.cn/WS01/CL0053/78464.html. 2013-01-22.

Author’s information: CHEN Yu-wen, Professor. Major research area: GSP. Tel: 024-23986552, E-mail: cywwyc@163.com