Quality System_R&D Center_Hangzhou Sinodo Pharm Technology Co.,Ltd

Peptide Research and Development Company

159 6718 4799

Quality System

Peptide R&D Quality System:

  We regards "seeking survival by quality and seeking benefits from management" as our quality policy, and has been working on the construction of a quality management system since its born. According to the requirements of ICH Q10 "Drug Quality System", a compliant and efficient R&D quality system has been established, which can run through the entire process of drug R&D, technology transfer, commercial production, and product termination.

        Our quality system documents include three levels of standard management procedures (SMP), standard operating procedures (SOP), and various documents and records.

        We have established an independent quality assurance department to perform functions such as change control, deviation management, CAPA management, supplier management, and product quality review management, ensuring that research and development activities are compliant, authentic, and effective.

   We have established a complete training system, including pre job training for new employees, post skill improvement training for employees, GMP and ICH regulatory knowledge training, and external training.

  All of the important instruments and equipment involved in the company's R&D and production activities have been qualified or calibrated.

  We have specialized material management documents and management personnel to ensure the correct distribution, use, and traceability of materials.

   We have set a standardized EHS management system to ensure the R&D and production activities safety, environmental protection and standardization. 



Manager Wang:159 6718 4799

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