Falsified Medicines Regulations of Annex 16 and their practical implementation
The revisions particularly include globalization and require that the entire supply chain be documented, ranging from the active pharmaceutical ingredient, i.e. the components used in producing the active substance to the import and storage of the intermediary products and distribution of the final medicine. The qualified person (QP) responsible for the quality and final release of the product must know the entire supply chain and ensure that all production and storage sites are authorized to carry out their assigned activity.
How can these complex requirements be implemented in practice?
Any supply chain documentation must be updated on a regular basis. The Annex 16 directive does not specify relevant intervals and methods. From our experience we know that for companies that are active on international markets, simple written documentation often constitutes an insufficient method of capturing the complex structures of the supply chain and ensuring regular monitoring. One of our customers, a global pharmaceutical corporation, therefore decided to develop and launch two software solutions. We established a business process for the verification of the supply chain by the qualified person.
Through this process we enable the qualified person to
- maintain full transparency of the batch-specific supply chain by means of daily updates from various IT systems and GGMP certificates,
- adjust the actual and target states of the supply chain in order to prevent the intrusion of falsified batches,
- guarantee GMP compliance (including Annex 16).
Do you have any questions about Annex 16 or do you need help to implement the GMP regulations? Please contact us!
Global Head of Business Development