GMP Certification

Guangzhou Westpoint Pharmatech. Co., Ltd.

We help our clients to establish the EU, US and China’s GMP system, completely improve the company's comprehensive strength and market compatibility, built up the foundation for company's long-term development so as to increase company’s potential value.

Our company has experienced team for EU and US GMP compliance, drug regulation, technical consultation and qualified European/American GMP certification project. All that will ensure the rapid and high-quality global GMP certification for pharmaceutical enterprise.

Process of global GMP certification:

1. Pre-auditing and discrepancy analysis

2. Hardware evaluation and modification

3. Personnel training and manufacture process design

4. GMP system establishment and revision

5. Establishment and revision of validation system

6. Application of EU and US GMP certificate 

7. GMP inspection and certification training

Our company relies on the profound understanding and broad experiences in pharmaceutical industry technology and regulations as well as EU and US GMP implementation. That can not only enhance the standard of GMP implementation for pharmaceutical companies and meet the requirements of GMP certification in EU and US, but also can significantly improve the quality for personnel in pharmaceutical enterprise to achieve work efficiency and economic benefits.

GMP document system

The GMP document system is essential for management system.

The management system, GMP documents system and personnel training system should be performed three in one, such as the establishment of an effective quality system and the implementation of GMP.

Process analysis is an effective approach to achieve this goal.

Our company has established a unique GMP system of working procedures, which can rapidly and efficiently improve the overall regulatory, technical and personnel qualification in pharmaceutical enterprises. GMP process which is based on scientific and reasonable method is designed and can be modified after process analysis.  That will help our clients to improve the qualification of personnel system, management system, and GMP system. All these three systems are essential to ensure the working efficiency, cost reduction and economic benefit.

Main completed GMP projects include:

• Grunenthal, Germany: Zhongshan, China;

• Ferring, Switzerland: Zhongshan, China;

• HEC Pharmaceutical : Dongguan, China;

• Zizhu Pharmaceutical: Beijing, China;

• Salubris Pharmaceuticals co., LTD.: Shandong, China;

• Jinmeiji pharmaceutical: Guangdong, China;

......

More than 50 European and American GMP projects have been completed so far.