Included in audit:

• Class I: An onsite preliminary assessment of equipment and process capabilities related to product design.
• Class II: Platform specific audit e.g. hotfill, tunnel pasturized, aseptic carton/PET ESL, non-ESL and is conducted by a process specialist to determine the technical suitability of the equipment to manufacture to specification.
• Class III: A comprehensive onsite assessment of the manufacturing site's people, process and system capability for a sustainable operation covering the following elements:
• • Aseptic system design assessment and review- including UHT, aseptic tank and aseptic filler
• • Micro lab operations
• • Allergen management program
• • CIP design and performance
• • Change management
• • Finished product test results review
• • Environmental testing review
• • Calibration program review
• • Planned preventive maintenance program review
• • Non-conformance procedure and record review
• • Customer complaint procedure and record review
• • Traceability and recall procedure and record review