cGMP Compliance Consulting

The cGMP compliance consulting will be conducted in accordance with FDA抯 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.

• 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

• cGMP Compliance Audit on Quality System and Gap Analysis
• Mock FDA Routine Inspections
• Response to FDA 483s
• Response to FDA Warning Letters