Quality management system
- Categories:Core competence
- Time of issue:2020-09-15 09:52:26
Guided by the concept of quality culture, we have established a high standard quality management system in accordance with the requirements of FDA and nmpa. We have successfully passed the GMP audit of FDA and the National Bureau of state in August 2019 and June 2020. As a professional CMO enterprise of humanwell Pharmaceutical Group, we strictly abide by GMP and CGMP regulations and guidelines in the production process of each product, optimize the process transfer strategy with customers, minimize the potential quality risk, and strive to do the right thing for the first time!
Quality policy: gather the sea of customer satisfaction, build a ship of perfect quality; raise the sail of enterprise brand.
Quality vision: continuously improve the quality system, provide customers with professional quality control strategy, ensure the orderly flow of materials in the production process, product quality is controllable, the work flow is clear, the equipment parameters are appropriate, and the personnel training is sufficient, so that the transfer process is smooth, clear and controllable.
File system architecture:
Level I documents: quality manual / factory master document;
Secondary documents: standard management procedures;
Three level documents: standard operating procedures and inspection methods;
Level 4 documents: production records and inspection records.
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