ANVISA GMP certificate must be obtained for following types of products by the manufacturing companies who wish to enter Brazilian market :-
- Pharmaceutical Drugs
- Medical devices falling under high risk of classification like Implants
- New product for ANVISA authority
INMETRO certification must be obtained for following products like :-
- Products with Needles like Syringes
- Electronic Devices
- Surgical Gloves
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.
Also, supports in obtaining INMETRO certification for ANVISA that is required for certain kind of products.
