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ANVISA Audit Preparation

How to prepare for ANVISA audit?

Which areas should be prioritized?

@sayeed

As a part of ANVISA audit preparation following areas should be prioritized:

  • HVAC systems and water treatment systems
  • Quality systems
  • Validation procedures
  • SOPs
  • Specifications and analytical methods
  • Hygiene conditions
  • Training of employees in production, quality control and quality assurance
  • Separate production lines for the production of human and veterinary medicinal products