Turnkey Solution for Major Pharma
aport were successful in a bidding process for the provision of turnkey solutions for a major pharmaceutical customer based in the UK. The customer required a solution which encompassed the project management of all required services for the relocation including pre and post move decommissioning and re-commissioning services, qualifications and the management of these services by all of the selected OEM’s/vendors.
aport would carry out the physical element of the relocation deploying all of its quality standards and processes across the need to relocate instruments, cold chain materials, data and dangerous goods.
The aport project managers were instrumental in bringing together all of the stakeholders on the project including the senior management team, scientists, buildings contractors, architects and laboratory personnel to ensure that the delivery of the full relocation was managed and completed on time and within budget.
aport were asked to provide a scope document following initial consultations which included our approach and considerations which included a RAID log (Risks, Assumptions, Issues and Dependencies) providing the customer with an initial review of risk.
An asset listing exercise was then completed by our project management team over a period of three months which captured data on all of the instruments including dimensions, bench requirements, peripheral equipment and all required services.
The asset list was seen as comprehensive, true and live and was used to further develop the architect’s plans which then ensured the contractors start data could be maintained and the project begun on time.
During this period the aport project managers handled a lot of liaison and communication between all of the different parties helping to drive the project forward and ensure that all stakeholders no matter at what level were kept informed of the projects progression. aport ran a series of informal internal events laboratory by laboratory communicating the project steps, the impact of the move on each department and the role they had to play in ensuring success.
All OEMs and service vendors were fully managed by aport including the scheduling of engineers in line with the move management plan, the OEMs were paid by aport directly ensuring that all management of delivered services didn’t have an impact on the customers employees leading to a continuation of science and development which was critical to the projects ultimate success.
The relocation itself was all on site following extensive additional construction to the existing facility along with the fit our and refurbishment of current laboratory facilities. This required the relocation of laboratories internally and sometimes meant that a laboratory needed to be moved more than once as working space was used to accommodate laboratories during the refurbishment process.
Although the relocation was all internal aport approach the project as it always would, writing detailed protocols for the handling, packing and movement of all instrumentation that dovetailed into the necessary GMP audit trails.
Cold chain materials including 2-8, -70 and -20 needed to be relocated. Although these were internal moves aport did not take any chances with the management of temperature integrity and utilised our range of specialist validated shipping systems for the considerable level of materials that needed to be relocated on site. In addition a full audit trail needed to be provided as the majority of the materials were linked to clinical trials.
aports experienced project managers were able to offer full validation data to the customer for each of the temperature controlled shipping systems that were deployed with data loggers utilised in the 2-8 and -20 shippers that needed to be housed in the systems for up to three days whilst static fridge and freezer units were transferred and brought back to temperature.
Full chain of custody protocols were utilised to ensure the audit trail including temperature integrity could be delivered back to the client with some confidence that commercially sensitive research samples had been transferred with no temperature excursions or issues of integrity.
The project was complex due to the number of stakeholders and third party providers that were involved and the scale of the move was relatively large with some 3000 instruments relocated.
The relocation was handled over a period of nine months with regular phase end audits conducted to ensure that the project was not only being delivered on time but that lessons from each phase were learnt, documented and then acted upon for each new phase.
Additional projects at the same site have since been awarded to aport from this customer.