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Quality & Compliance

High Standard Quality System

Quality System of Sinopep covers the entire lifecycle of a product including all phases of clinical developments, commercial launch and post launch etc.

  • Quality System
  • Laboratory Control System
  • Material Management System
  • Production Management
  • Facility & Equipment Management
  • Packaging & Labeling System

These elements are appropriately implemented and applied to all stages throughout the entire product lifecycle, recognizing the objectives and differences of these stages.

Potential opportunities for quality improvement and efficiency optimization via innovative solutions would be thoroughly evaluated and implemented at proper timepoints in a compliant fashion.


Quality Oversight

Working as an independent unit, Sinopep’s QA involves in all aspects of development and manufacturing activities in order to prevent product defects, identify and resolve quality impacting issues, and constantly seek opportunities to make improvements.

  • Vendor
  • Raw Material
  • Process
  • Product
  • Client
  • Compliance QA
  • Project QA
  • Floor QA
  • Validation QA

Quality Commitment

Sinopep is fully committed to providing the highest quality products and services. The Sinopep "Quality Manual" is established based not only on the requirements of regulatory agencies such as NMPA, US FDA, EMA, ICH, and regulatory guidelines such as 21 CFR Part 210/211/820 and ICH Q7/Q8/Q9/Q10, but also on Sinopep's top management's strong commitment to ensuring our operation and control of processes in CMC (Chemistry, Manufacturing and Controls) are conducted in full compliance meeting the highest level of global quality requirements.


Proceed in a Compliant Manner IP Protection

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    Documents Are Encrypted Automatically

    When created/edited and all traceable.

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    Automatic Watermark

    Watermarks on computer screens/printed materials

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    Employee Training

    IP protection training to enhance employee awareness

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    Team Supervision

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