Confidence Beyond Compliance
In today’s modern pharmaceutical industry and increasing globalisation of Pharmaceutical Supply Chains, the supply chain often extends across multiple transportation routes and regulatory jurisdictions, and may include sourcing pharmaceuticals from outside of the EU/EEA for distribution within the EU/EEA, or sourcing pharmaceuticals from within the EU/EEA and distributing globally.
Current regulatory expectation is that the pharmaceutical distributor has full awareness, control and management of the supply chain from procurement through storage and transportation, and supply to the customer.
In addition, Annex 16 of the EU GMP guide requires that documented information on the entire supply chain of the medicinal product, starting from the manufacturing sites of the starting materials and components, and including all parties involved in any manufacturing and importation activities of the medicinal product, is made available for the QP in order for the QP to certify the pharmaceutical product for release to market or for export. Annex 16 also requires QP certification of pharmaceutical product for products imported into the EU/EEA or for products manufactured within the EU/EEA for export and distribution globally.
GDP requires that the pharmaceutical distributor implements principles of Quality Risk Management, in accordance with ICH Q9, when assessing supply chain routes or making changes to any elements of the supply chain, whether in-house or outsourced. This requires the organisation to perform Supply Chain Risk Assessments, to be in compliance with GDP.
PharmaLex’s team of experts, which includes a number of former EU regulators, have the appropriate experience and expertise to provide services supporting the organisation’s Supply Chain Risk Assessment activities in compliance with GDP.
- Mapping detailed transportation routes from procurement, through warehousing and transportation and onward supply to the customer, and
- Performing a Supply Chain Risk Assessment to identify, assess and mitigate risks to the Pharmaceutical Supply Chain in terms of risks to the quality of the pharmaceutical product, for example, maintenance of transportation conditions in compliance approved storage conditions for the product, for example 2 – 8°C and/or “Do Not Freeze”, across multiple climatic zones
- Performing a Supply Chain Risk Assessment to identify, assess and mitigate risks to the Pharmaceutical Supply Chain in terms of risks to the security of the pharmaceutical product, and of falsified medicines entering the Pharmaceutical Supply Chain
- Performing a Supply Chain Risk Assessment to identify, assess and mitigate risks to the Pharmaceutical Supply Chain on the introduction of a new product, supplier, contractor or supply or transportation route to the supply chain
- Performing a Supply Chain Risk Review on changes to systems, procedures, suppliers, customers, partners and transportation routes, or to introduce a new product or transportation route to the Pharmaceutical Supply Chain
- Assisting the organisation in implementing actions to mitigate risks to the supply chain