How to prepare for ANVISA Inspections

Most supervising health authorities have developed regular inspection systems to allow the periodic verification that a pharmaceutical manufacturer (APIs and medicinal products) does comply with the applicable GMP regulations. Although the idea and content of GMP guidance is quite comparable, there is no common global GMP, and various inspectorates come and inspect facilities in other countries. The Brazilian ANVISA for example has published its own GMP Guidance.

ANVISA requests certain pre-inspection information. A Brazil company representative has to request the inspection six months ahead of a license due date. In the ANVISA website, the Brazil legal representative completes and submits comprehensive information about the product and the manufacturing facility in a foreign country, including geographical coordinates and information about inspections by other healthcare agencies. In case of a certification renewal (which is every two years), ANVISA decides if another inspection will be needed based on a risk assessment.

ANVISA inspections are considered to be quite tough and strict. Inspectors focus a lot on the facility and operations. They want to be on the floor, when products are being manufactured. ANVISA inspectors prefer to perform multi-product inspections and are well trained, experienced and speak good English.

What will they look for when they come for an inspection?

• HVAC systems and water treatment systems
• Quality systems
• Clearly defined validation guidelines and procedures (the "classical" approach with three consecutive batches is still expected)
• Involvement of (senior) management in the approval of SOPs, manufacturing documents and other documents
• Specifications and analytical methods
• Hygiene conditions
• Training of employees in production, quality control and quality assurance
• Demand for separate production lines for the production of human and veterinary medicinal products

At the end of the inspection, no report will be issued. But an inspection report must be generated within 30 days (the inspector does not decide how a defect is to be classified; this is decided after inspection within the authority). After a successful inspection, a GMP certificate will be issued.