Project 28735 - Manufacture and Supply of Avian and Bovine Purified Protein Derivatives (PPD) Tuberculin

Tender description

Manufacture and Supply of Avian and Bovine Purified Protein Derivatives (PPD) Tuberculin to the Animal and Plant Health Agency (APHA). This product is for use in its bovine tuberculosis (bTB) testing scheme, which is the cornerstone of the bTB eradication programmes in England, Wales and Northern Ireland and the surveillance programme in Scotland. Lot 1: Avian and Bovine Purified Protein Derivatives (PPD) Tuberculin is used in Defra's bovine tuberculosis (bTB) testing scheme, which is the cornerstone of the bTB eradication programmes in England, Wales and Northern Ireland and the surveillance programme in Scotland. APHA currently require approximately 3,300 litres of PPD Tuberculin on an annual basis. Deliveries will be required on a monthly basis, with the avian and bovine PPD Tuberculin supplied in a paired presentation kit, available in two vial sizes (2ml and 5 ml). The following quantities are required for the duration of the Contract: • a minimum of 140 litres of avian PPD Tuberculin per month up to a maximum of 190 litres per month; and • a minimum of 140 litres of bovine PPD Tuberculin per month up to a maximum of 190 litres per month. The contract is scheduled to start in 2022, with deliveries commencing in 2023, and the contract period will be 5 years (with a further 24 months allowable extension). Key manufacturing and supply standards are as follows: - UK-recognized Marketing Authorisations (MA) for both bovine and avian PPD Tuberculin products; - A current Good Manufacturing Practice (GMP) certificate recognized by the UK’s Veterinary Medicines Directorate (VMD) for the duration of the contract; - Product tested according to, and at the time of delivery compliant with, the general standards defined in the European Pharmacopoeia Current Edition (monographs 0536 and 0535). Note that the contract specification, to be issued as part of the Pre-Qualification Questionnaire (PQQ), will provide comprehensive information on the mandatory standards and requirements for this contract.