Shanghai OPM Biosciences Co., Ltd. has established a quality management system covering the entire life cycle of drugs covering production systems, plant facilities and equipment systems, laboratory control systems, material systems, packaging and labeling systems in accordance with the Good Manufacturing Practices for Drugs (2010 Edition), the Quality Management Practice for Non-Clinical Research of Drugs (Order [No. 34] of the State Food and Drug Administration (now National Medical Products Administration, NMPA)), and the ICHQ10 Pharmaceutical Quality System, including the management responsibilities to meet customer needs, process operation and continuous improvement of product quality.
The continuous improvement system of the quality management system, combined with quality risk management, data reliability management, technology transfer management and verification management, ensures the continuous and stable production of drugs that meet the intended use and registration requirements.
The OPM quality management system, covering the whole life cycle of drugs, is compliant with China/EU/US GMP requirements
- Good Laboratory Practice (GLP)for Non-Clinical Research of Drugs (2017)
- Good Clinical Practice (GCP) for Clinical Trials of Drugs (2020)
- Good Manufacturing Practice (GMP)（2010）