That certificate shows that pharmaceutical products are consistently produced and controlled according to “Good Manufacturing Practices” quality standards”. It includes protective measures regarding the conditions of the organization due to prevent and reduce the risk of contamination of the products from internal and external sources.
It is the quality management system standard based on the creation and continuity of the documentation of product and service processes. The certificate shows that the medical device manufacturer has a customized quality management system for the production, design, and sale of the products and continues its validity.
The notified bodies issued document confirms the quality of systems related to the product or production/design process. The certificate shows that the products included in the scope comply with the relevant directives defined in the European Union and have passed all necessary conformity assessment activities.
The certificate verifies that the company complies with the Medical Device Sales, Advertisement, and Promotion Regulation requirements and can continue to conduct medical device sales activities.
It regulates the manufacturing processes and principles for medicinal products for human use and their active ingredients, including clinical investigational products, the application of Good Manufacturing Practices and applicable national and international standards, and the implementation of the quality assurance system within this framework.