Challenge
GSK Vaccines have followed industry best practice to adopt the ASTM 2500 E risk based method of pharmaceutical facility qualification. The engagement was to take the guidance and draft qualifications protocols and to use, evaluate and improve these to facilitate and expedite the commissioning and qualification phase of two major vaccine facility projects.
Solution
Bob provided commissioning and qualification expertise to guide the use, evaluation, and improvement of these through Factory Acceptance Testing, incident resolution and Site Acceptance Testing. By using established Accelerated Delivery Performance tools and lean six sigma techniques, deviations and incidents identified in early testing could be resolved systemically and failure demand minimised or eliminated.
Result
The delays and difficulties seen in suppliers own testing were analysed, remediated, and not repeated in formal acceptance testing, both at the factory and at site. Consequently, formal verification testing could readily capitalised and reduced levels of testing without loss of assurance were permissible. Further benefit was gained from preapproved equivalence which enabled reduced testing for identical systems and equipment