Pre - Audit Inspection Services for Brazil GMP Certification

Mandala International can carry-out pre-audit inspection service for manufacturers of health products and medicines that required compliance with the respective Brazilian legislation to obtain Good Manufacturing Practices (GMP) certificate for ANVISA.

The objective of the pre – audit services would be to:

  • Inspect the facility installation where the manufacturing takes place.
  • Inspect the documentation of each production step
  • Inspect the quality control documentation for each manufacturing stage
  • Inspecting compliance of the finished product with the original blue prints.
  • Checking compliance of all other applicable activities

The pre-inspection team provides the pre-inspection report to the company recommending all the improvements to comply with ANVISA’s guidelines. 

Mandala International also provide assistance during the inspection being conducted by ANVISA authority. The quality assurance team would act as an intermediate between the inspector and the client to reduce language barriers or to execute possible actions during the inspection week to attend to the non-conformities and to meet the guidelines set up by the ANVISA authority.

Also, supports in obtaining INMETRO certification for ANVISA that is required for certain kind of products.