OPODIS Pharmaceutical – Pharmaceutical Co., Ltd achieved ISO 13485: 2016 certification

ISO 13485 is a standard for safety management systems for health products, issued by ISO. ISO 13485 is based on ISO 9001 as the foundation. This International Standard is intended to meet specific legal and customer requirements, manage risk and maintain efficient production processes, contamination control, product hygiene requirements, special requirements for sterile medical devices and product traceability requirements.

According to the provisions of Decree 36/2016/ND-CP on the management of medical equipment, the application of ISO 13485 is one of the mandatory conditions for the quality management system that manufacturers of medical devices. medical supplies and medical supplies need to be completed before launching products to the market from January 1, 2020. Through this regulation, facilities manufacturing poor quality medical equipment will have to stop operating, helping to reduce poor quality products on the market, consumers will be more assured when choosing products.

OPODIS PHARMA Company was established in 2007. The factory of OPODIS Pharma is designed and built according to good manufacturing practice standards of the World Health Organization GMP-WHO at the address: Lot 78, Linh Trung III Export Processing and Industry zones, Trang Bang District, Tay Ninh Province. After more than 12 years of development, the company has developed many quality product lines, derived from natural herbs.

With an area of ​​8,200 m² OPODIS factory includes:

– Production area: medicine production area, wind oil production area.

– Storage and distribution areas of drugs according to GSP standards.

– Research and development area of ​​R&D production.

– The operator block consists of departments, specialized departments, quality control (QC) and quality assurance (QA) rooms, which are equipped with modern equipment according to GLP standards. With modern equipment, qualified and trained human resources on GMP, OPODIS PHARMA can reach a capacity of 5,000 liters / day, an average of 500,000 to 1,000,000 liters/year.

During the evaluation process, the auditor raised many issues that OPODIS encountered so that the company could conduct improvements and perfect the quality management system in the production of its medical equipment and supplies. By assessing the production area, raw material warehouse, finished product warehouse, and reviewing the overall management system, production operation processes, production monitoring forms, instructions to maintain the protection conditions. In this course, experts determined that OPODIS basically meets the requirements of ISO 13485: 2016 and is eligible for certification.

Benefits of OPODIS PHARMA in particular and medical device manufacturers in particular when applying ISO 13485: 2016:

• Meet the mandatory requirements of Decree 36/2016/ND-CP on management of medical equipment
• Create more trust with customers
• Labor productivity is increased
• Has a competitive advantage over similar products
• Improving quality and products
• Control hazards of hygiene and have specific plans in a timely manner
• More accessible to foreign markets
• Convenient to integrate with other management systems (ISO 9001, ISO 14000, …).

Productivity and Qualtiy Office