Good Manufacturing Practices in China

After the State Drug Administration (SDA) was established in 1998, it took a firm hand in supervising China's pharmaceutical industry. SDA decided that all pharmaceutical manufacturers must meet GMP standards and obtain GMP certification before June 30, 2004. Since that time, guidances for the following products have been developed:

• biological products and blood products (Dec. 31,1999);

• powders for injection and infusion (Dec. 31, 2000);

• injectables (Dec. 31, 2002);

• all products (June 30, 2004).

SDA reissued the GMP regulations in 1999. China's Drug Administration Law states that all pharmaceutical manufacturers must observe GMPs beginning July 1, 2004. In April 2003, SDA was renamed the State Food and Drug Administration (SFDA). Although SFDA authorized provincial drug administrations to accelerate GMP examination in 2002, only approximately 3800 of the previous 6400 pharmaceutical manufacturers met GMP regulations as of July 1, 2005.

Kong Liang

At the same time, China's government is strengthening GMP examinations. A GMP examination regulation effective Oct. 1, 2005 specifies that SFDA is responsible for establishing GMP examination standards and revision and the investigator database; examining injection, biological products, and radioactive products; and examining imported products for compliance with GMPs and international mutual recognition. The Provincial Drug Administration is only for local GMP examination for products other than injectables, biological products, and radioactive products.

Applicants should submit the following documents when applying for GMP certification: a GMP application form; a production license; a self-examination of manufacturing and management; an organization chart; the curriculum vitae of the company leader and subleaders; all forms and drug lists of the company; new drug certificate and drug-production standards; a company layout and description of the environments; a brief description of manufacturing workshops and air-cleaning systems; the process chart for the GMP application; validation for key processes, equipment, water systems, and air-cleaning systems; verification of the apparatuses and instruments; document lists of manufacturing management and quality management; and fire safety and environment protection certificates.

A newly established company must submit the batch production records of its products, in addition to the above documentation. Drug administrations provide a technology review within 20 days of receiving the application. If additional documents must be submitted, the authorities will request the company to submit them all at once within two months. If the documents are not received, then the application is terminated.

The authorities will set the on-site examination procedure within 20 days for those meeting all technology requirements. The inspection team will consist of three inspectors, selected at random from the national GMP inspector database. SFDA will make a decision within 40 days after receiving the on-site examination report. The Provincial Drug Administration makes a decision in the specified time after receiving the on-site examination report and then submits it to SFDA. SFDA then will issue a notice for those eligible companies to obtain GMP certification if there is no objection within 10 days. GMP certification then will be granted and will be valid for five years. Manufacturers should resubmit a GMP application six months before their current GMP certification expires.

Kong Liang is a project manager at APEX China Co., Ltd., Room 202, No. 2, Lane 418, Mudan Road, Shanghai, 201203, China, liangkonglang@yahoo.Com.cn