Documentation for global vaccine supply.

BAP Pharma was contacted to source a vaccine from the US for supply as a comparator product for a clinical trial within Europe. A source of the vaccine was confirmed through an established Wholesale Dealer located in the US who purchased the vaccine directly from the original manufacturer.

“Sourcing comparator products via a short supply chain, where all parties are known, significantly reduces the risk of purchasing a falsified medicine compared to purchasing through a broker or parallel trader.” [Bashir Parkar]

When sourcing material from outside Europe the BSE/TSE statement of compliance can prove difficult to obtain. In the US the BSE/TSE evaluation forms part of the New Drug Application submission so it is not always provided as a statement from the manufacturer. In this case, there was no certificate available. BAP Pharma’s solution for overcoming this challenge was to obtain sufficient information from the manufacturer to conduct a risk assessment with both BAP Pharma’s QP and the Sponsor QP, alongside continuous involvement with the UK Competent Health Authority. This was done to assess the information obtained for BSE/TSE and make a decision on whether sufficient information was available to allow for QP certification. Performing a risk assessment for this activity is atypical but BAP Pharma worked closely with the UK Competent Health Authority to confirm that such a risk assessment could provide a robust solution to the challenge.

This import activity also required a QP Technical Agreement to be in place between BAP Pharma and the Sponsor Organisation to define the specific roles and responsibilities for the QP certification.

Despite the process being complex, and involving the movement of the goods across International borders, BAP Pharma was able to use their expertise and network to ensure the products arrived on time and in perfect condition.

1BSE/TSE statement is a document that certifies a product is free from Transmissible Spongiform Encephalopathy and Bovine Spongiform Encephalopathy