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