China Pharmaceutical Engineering Association Pharmaceutical GMP Revision Seminar Held in Beijing

On November 6, the China Pharmaceutical Engineering Association's drug GMP revision seminar was held in Beijing. The reporter learned at the meeting that the GMP revision is mainly based on the World Health Organization's GMP. Unlike the 98 version of GMP, the new version of GMP is enlarged. The requirements for aseptic production.

Gu Weijun, secretary-general of China Medical Equipment Engineering Association, pointed out that at present, there are no domestic enterprises that produce preparations that meet the export conditions, and they have reached the point where they can't change. The revision of GMP has adapted to the needs of internationalization.

Gu Weijun said that the purpose of this GMP revision is to comprehensively improve the quality assurance of pharmaceutical products, and on this basis, promote the export of Chinese pharmaceutical preparations and APIs. The new version of GMP is in line with international standards and is expected to clear the way for China's drug exports.

At the meeting, the main question raised by the representatives of the participating enterprises was how to adjust the product structure and avoid blind investment after the introduction of the new version of GMP. Guo Qingwu, director of the Safety Supervision Department of the State Food and Drug Administration, answered these questions.

According to reports, this revision adds quality attorneys, quality risk management, product quality review analysis, continuous stability inspection plan, supplier audit and approval, change control, deviation management, over-standard (OOS) investigation, corrective and preventive measures. (CAPA) and other content.

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