GMP in China's Cosmetic Industry

The rapid development of China’s cosmetic industry over the last two decades has seen the establishment of a large number of domestic enterprises and an influx of foreign enterprise. However the majority of domestic enterprises are plagued by quality and hygiene management issues, poor R&D capacity, substandard manufacturing technologies and staff poorly trained in hygiene and safety. In December 2013 the CFDA designated Guangdong’s FDA to draft the Chinese cosmetics Good Manufacturing Practice (GMP). To this end Guangdong’s FDA convened a who’s who of leading experts from CFDA or FDAs, review and approval institutions and well-known cosmetic companies to aid in the development of China’s GMP regulations. The draft of the GMP regulation is now completed but has not been scheduled for release yet. Liu Yuan, Vice President of Guangdong FDA Technology Association for Evaluation and Certification did however disclose the contents of China’s first cosmetics GMP regulation in advance.

China’s cosmetic GMP regulation has borrowed heavily from its international counterparts in the EU, US, ASEAN, etc. The Chinese cosmetic GMP also takes into consideration the particularities of China’s cosmetics industry and its supervision status quo. Liu Yuan stated that the Chinese GMP stipulates the same high demands as foreign GMP. The Chinese GMP includes stipulations regarding hardware, software and personnel. It also adopts all contents of ISO22716:2007 except commission processing.

Furthermore, Liu Yuan disclosed 10 chapters are included in the GMP. They are as follows:

1. General Provisions

This chapter stipulates the object and basic requirements of GMP and makes clear provisions that manufacturers are allowed to meet the requirements specified in this GMP by using other advanced and validated methods or technologies.

2. Institutions and Personnel

This chapter stipulates that manufacturers shall establish an organizational structure corresponding with the production scale and product mix and allocate qualified managers and operators. The heads of manufacturers are responsible for the quality and safety of products. Moreover, the requirements for quality director, head of quality control department, production director and training of employees are clearly mentioned as well.

3. Quality Control

This chapter explains the position and function of the quality control department and stipulates the responsibilities and regimes of the quality control department such as file management, lab management, disqualified products management, risk management, etc.

4. Plants and facilities

This chapter stipulates the requirements of plants’ layout, production plant, storage area and cleanliness of production environment.

5. Equipment

This chapter stipulates the requirements of design, selection, and installation of production equipment and makes provisions about the calibration, operation and maintenance of productive and testing equipment.

6. Materials and Products

This chapter makes provisions about the purchase, acceptance, storage, dispatching and usage of ingredients and packaging materials.

7. Production Management 

This chapter makes provisions about the critical factors affecting the quality of products.

8. Validation

9. Sell, Complaints, Adverse Reactions and Recall of Products

10. Supplementary Provisions