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

Documents Are Encrypted Automatically

When created/edited and all traceable.
Automatic Watermark

Watermarks on computer screens/printed materials
Employee Training

IP protection training to enhance employee awareness
Team Supervision

Watermarks on computer screens/printed materials