On site audits by our qualified staff can be arranged. Audit teams are lead by industry experts.

The API chemistry, manufacturing, and controls audit includes:

  • Quality Management
  • Personnel
  • Buildings and Facilities
  • Process Equipment
  • Documentation and Records
  • Materials Management
  • Production and In-Process Controls
  • Packaging and Identification Labeling of APIs and Intermediates
  • Storage and Distribution
  • Laboratory Controls
  • Validation
  • Change Control
  • Rejection and Reuse of Materials
  • Records and Reports
  • Recalls
  • Contract Manufacturers (Including Laboratories)
  • Agents, Brokers, Traders, Distributors, Repackagers, and Re-labelers