GMP has been implemented in China for than 20 years, and pharmaceutical companies have experienced from voluntary certification to mandatory certification course. One side, the upgrading of premise, facilities and equipments, reduced the gap with the international pharmaceutical industries, professional team has been training and development. On the other hand, by high intensity flight inspection, special inspection and follow-up inspection, SFDA found that the majority of GMP certified pharmaceutical production enterprises can manufacture according to requirements, but some enterprises have serious violations of GMP and relevance laws and regulations.
How to comply with the GMP and state laws and regulations, that is a seriously problem for pharmaceutical industry.
How to understand and confirm whether there is a GMP violation? Whether the enterprise continues to keep the GMP status? Whether the enterprise comply the relevant regulations of pharmaceutical manufacturing?
How to check all declared datum (including drug registration / application, GMP certification Declaration, and so on) are consistent with the situation, the data is accurate, true and reliable?
How to find the problems by audit and take corrective action so that the effective operation of the manufacturing and quality management system, and continual improve to perfect the system?
This is what need to be solved in audit service. We hope to perform a comprehensive quality management system inspection for enterprise, in order to:
● Exposure potential problems
● Improve operational efficiency
● Risk alert
● Training management personnel
We stand in the position of third parties to audit all aspects of the quality management system, based on risk management and control. Comprehensive assessments to confirm that the enterprise's risk rating, provide powerful guarantee for the development of enterprises.