Preparing to Succeed with ANVISA Audits
Preparation for any audit relating to medical devices or medical device manufacturing is critical to a successful outcome, but preparing for an ANVISA audit can take the process to a new level. The Brazilian monitoring authority ANVISA (Agência Nacional de Vigilância Sanitária, or the National Health Surveillance Agency) is also responsible for medical devices. It published Resolution RDC No. 59 that documented GMP (Good Manufacturing Practice) requirements for medical devices. The resolution hopes to “establish and implement requirements for Good Manufacturing Practice of establishments that manufacture or market medical devices.” These GMP requirements are very similar to those implemented by the US FDA for medical devices, like 21 CFR 820 and other QSR (Quality System Regulations). The ANVISA GMP requirements encompass an eight-page checklist divided into four medical device classes (low, medium low, medium high, and high-risk potential). As the Brazilian GMP provisions are very similar to those in 21 CFR 820, reviewing the eight-page inspection checklist may be another great way for manufacturers or contract medical device manufacturers to prepare for audits.
Clear Communication Is Key to Becoming ANVISA Approved
The checklist is important, but communication is one area I would consider to be critical to the outcome of an audit. Language can at times become a barrier and may lead an auditor to conclusions that are not accurate. This is where a good translator may come in handy; he or she can play a very important role during the audit. Cogmedix, a medical device contract manufacturer, experienced an ANVISA audit this year. We were fortunate enough to have our customer’s third-party consultant, who translated during the entire audit. The four-day audit was very compressive and thorough. The inspectors (two of them) took a methodical approach that challenged all areas of our quality management system. Our consultant/translator allowed for a clear and effective line of communication that resulted in a positive and successful audit outcome. In this particular case, the Cogmedix quality management system held strong and there were no incriminating findings.
At the end of the day, your documented quality management system should stand on its own, but communicating it effectively is a key part of your successful ANVISA audit.
Scott Cook, Vice President of Quality and Compliance