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cGMP Compliance Consulting

The cGMP compliance consulting will be conducted in accordance with FDAs requirements (21 CFR Part 210 & 211 with its interpretations
for dosage forms and ICH Q7 for APIs). We will support our clients in building an overall cGMP - compliant quality system in terms of
hardware, software, and personnel. Our experienced consultants will conduct on-site consultation in conjunction with off-site document review.

Service
  • cGMP Compliance Audit on Quality System and Gap Analysis
    • General GMP audit
    • Special GMP audit (in particular aspect)
    • Audit on contractors
  • cGMP Compliance Review of Facility Design and Construction
    • Guide GMP requirements for facilities
    • Review design drawings
    • Audit on constructions
  • Validation System
    • Master validation plan and project plan
    • Design and review validation protocols
    • Review validation results and reports
  • Documentation System
    • Corporate level documents and master record
    • Management level documents
    • Operational level documents and batch record
  • Laboratory Control System
    • In-process material control tests
    • Product final release tests
    • Validation of analytical methods
    • Housekeeping and management of lab operations
  • Production and Process Control System
    • Equipment qualification and process validation
    • Environment and process monitoring
    • Calibration and maintenance
    • Batch records and SOPs
  • Quality Assurance System
    • Change control
    • Product annual review
    • GMP and SOP-based job function training
    • Batch record review
    • Deviation and investigations
    • OOS and investigations
  • Material Control System
    • Vendor evaluation and control
    • Material incoming, storage, and dispatching
Other Services
  • cGMP Compliance Audit on Quality System and Gap Analysis
  • Mock FDA Routine Inspections
  • Response to FDA 483s
  • Response to FDA Warning Letters