We are thrilled to announce that Sanatmetal has passed a rigorous 4-day audit by the Brazilian Health Regulatory Agency, ANVISA, with 2 auditors reviewing the correctness of Sanatmetal’s processes and procedures during the period 6-9 March 2023.
ANVISA’s mission is to safeguard and promote the health of the Brazilian population through executing sanitary control of the production and product usage. As part of their quality control process audits are carried out on all domestic and foreign companies selling their products to Brazil, in the following areas: pharmaceuticals, food, cosmetics, medical devices, healthcare products and services, official laboratories, pesticides and tobacco. Sanatmetal Ltd. operates in the knee and hip replacement product industry within the country, which means the high-risk categories of III and IV and should meet with the strictest requirements.
Once again, their auditing methodology has demonstrated its sophistication. A total of 35 documents; procedures, instructions and policies were requested for review, and 3 validation processes were reviewed from start to finish; for cleaning, cleanroom and ethylene oxide sterilisation. As a result of having two auditors present, the 4-day audit lasted as long as 8 audit days. This meant that we dedicated approximately 35% of our time in March to ANVISA audit related tasks while still ensuring that our partners received the same high quality service they have come to expect from us.
We are proud to say that, based on the objective evidence collected during the audit, ANVISA’s auditors concluded that Sanatmetal’s quality system meets the requirements of the Brazilian GMP RDC 665/2022. As a result, we will be issued with a renewed BGMP certificate confirming good manufacturing practice.
At Sanatmetal, we strive to ensure the highest standards in our production thereby improving the quality of human life and the renewed GMP certification is a significant milestone on this journey.