Quality compliance of active substances/medicinal products from storage to marketing must be ensured. In addition to GMP (Good Manufacturing Practice), GDP lays down guidelines for the distribution process for medicinal products in order to prevent loss of quality during transport.
GDP applies to all divisions of a company and establishes regulations for quality assurance for active substances and medicinal products. Initially, a quality assurance system must be installed. Purchase, storage, supply and export processes of medicinal products and active substances need to be defined in this system. Additionally, many processes like product recall or withdrawal have to be described in detail. Furthermore, GDP makes high demands on detection and management of counterfeit products in conformity to the EU guideline 2011/62/EC and EU Comission delegated regulation 2016/161.
Moreover, GDP requires risk-based qualification of the storage areas, equipment and means of transportation. Alert levels have to be defined dependent on the stored product. Employees executing storage or transportation have to be trained in GDP demands and effectiveness of the training has to be proved regularly.
A transport validation that proves stable and verified climatic conditions during the entire transport and controlled transport conditions with climatic monitoring guarantee consistent product quality during transport especially for temperature sensitive pharmaceuticals.
For the implementation of GDP, a responsible person has to be designated, who has to be trained on GDP and is responsible for the compliant handling of medicinal products according to guidelines. The area of responsibility of this person also includes processing of deviations, recalls, counterfeits and complaints.
Valicare GmbH, a part of Bosch Packaging Technology, supports pharma customers all over the global market with the implementation of GDP demands. We assist companies with qualification of storage areas, equipment and means of transportation. In doing so, we comply with the latest state of the art in science and technology and the globally recognized standards and regulations. Feel free to contact us or visit our website for further information
Dr. Ellen Sons-Brinkmann
Phone: +49 69 7909 350