Challenge
Wyeth Medica (Pfizer) Grange Castle project was a strategic investment for manufacture of Enbrel sales in EMEA and rest of the world (RoW). The Dublin campus provided for all manufacturing and development operations of the drug, from pilot scale, bulk biologics manufacture, together with facilities for Administration, Quality Assurance and Control.
The requirement to complete construction, commissioning, and qualification of both the facilities and the laboratory equipment to provide a fully working QC facility to support the large numbers of samples analyses required by Drug Substance and Product during their respective qualifications.
Solution
Bob lead a contract, team of commissioning and validation engineers from preparation of the necessary verification and validation protocols for all equipment (including all laboratory bench and fixed equipment), through protocol execution and final reporting. The team also provided the practical hands-on turnover of the systems, pre-commissioning, commissioning and performance optimisation followed by handover for beneficial operation.
Result
The original programme of 9 months for this activity was reduced by 3 months by employing the “Critical Chain” scheduling approach. The processes for verification and validation were simplified and honed to minimise deviations and incidents that could delay acceptance and qualification.