On 5 November 2015 our firm passed with positive outcome a certifying audit of management system according to PN-EN ISO 15378:2012 ?Immediate packaging materials for medicinal products ? Detailed requirements regarding application of ISO 9001:2008 taking into account Good Manufacture Practice (GMP)?.
Good Manufacture Practice is a set of principles to ensure manufacturing and controlling packaging products, adequately to their intended use and in accordance with requirements contained in their specifications. Good Manufacture Practice (GMP) is a set of manufacturing procedures which especially focus on production hygiene and prevention of manufacturing products not meeting quality requirements.
Application of requirements of PN-EN ISO 15378:2012 aims to ensure repeatability, quality and uniformity of products by means of strict supervision over the manufacturing process, starting from the raw material supply stage, material storage, manufacturing, packaging and labelling, up to the moment of storage and distribution of finished products. The standard ensures manufacturing of products that consistently satisfy customers? needs, including statutory requirements and international norms, which apply to original materials for packaging.