PRE-INSPECTION (MOCK INSPECTION)
The pre-inspection work is carried out in the national or international manufacturers of health products and medicines that require to be in compliance with the respective Brazilian legislation to subsequently receive the sanitary inspection performed by ANVISA. So far, the technical team of Vera Rosas has already performed factory pre-inspections practically all over the world, including USA, Canada, France, Germany, Italy, Switzerland, UK, Ireland, Greece, China, Taiwan, India, Israel and Costa Rica.
The purpose of this pre-inspection or mock inspection is:
- Evaluate in detail the quality system of the company against Brazilian legislation, through the request of procedures, forms, reports, protocols, and other documents that evidence the application of standards, legislation and other concepts of good manufacturing practices;
- The pre-inspection team provides the company with the pre-inspection report to formalize noncompliance’s and recommendations for improvement;
- Define with the companies the corrective actions necessary to adapt the occurrences identified during the pre-inspection.
Inspection monitoring is the service offered by Vera Rosas for international companies that will receive the inspection of the Agency of Sanitary Surveillance, ANVISA. The objective of this work is to provide the necessary support during the inspection in order to mitigate risks that may lead to the refusal of the international certification of Good Practices, which generates costs and distress for the company. Vera Rosas Quality team is able to intermediate the communication between inspector and auditee, to execute the possible actions during the inspection week to attend to nonconformities and to meet the requirements issued by the sanitary agency, collection of the attention process requirement, protocol of the process and follow-up until the publication in the Federal Official Gazette.