Suzhou YikangGMPVerification project verification process:

uValidation Master Plan (VMP)Verify the master plan

uUser Requirement Specifications(URS) User Requirements Explanation

uFunction Specification (FS) Functional Description

uHardware/Software Design Specification (HDS/SDS)

uDesign Qualification(DQ) Design Confirmation

uRisk Assessment (RA)risk analysis

uFactory Acceptance Test (FAT)Factory accepts testing

uSit Acceptance Test(SAT) On site testing

uInstallation Qualification (IQ)Installation Confirmation

uOperational Qualification (OQ)Operational Qualification

uPerformance Qualification (PQ) Performance Qualification

The company's product production validation scope is divided into six categories, namely:

1Instrument calibration and verification of inspection methods

2Verification of factory facilities and public systems

3Equipment verification

4Cleaning verification

5Process validation

6Other (material storage time, disinfection effect verification, etc.)

7The scope of verification for factory facilities and public systems is divided into four categories, namely

(Facility validation, air conditioning purification system validation, water system validation, compressed air system validation)