Frequently Asked Questions
When will the Drapers Yard clinic officially open?
We welcomed in our first volunteers to the clinic on Sunday, March 19, 2023, and conducted our first dose from Drapers Yard on Monday, March 20.
What regulatory inspections will be taking place, and when?
We completed a Medicines and Healthcare products Regulatory Agency (MHRA) accreditation inspection of the clinic from March 16-17, 2023. The MHRA Good Manufacturing Practice (GMP) pharmacy audit will be planned for late Q3 or early Q4.
Who is the point of contact for organizing audits?
Requests for audit of compliance with Good Clinical Practice (GCP) at Drapers Yard should be sent to [email protected]. Audit requirements will be discussed, and on-site audits scheduled at a mutually convenient time on request.
Requests regarding GMP pharmacy audits at Drapers Yard should be sent to [email protected] to schedule a mutually agreeable time for an on-site or virtual audit. Audits will not be scheduled until late Q3 or early Q4.
How is the move to the new clinic being managed?
We completed clinic activities at our Springfield House facility on Friday, March 10. Screening and outpatient visits continued in a defined area of Springfield House for one additional week.
Clinic equipment and systems was transferred from Springfield House to Drapers Yard in a planned phase program. Newly purchased equipment and systems arrived at Drapers Yard from February 18, 2023. All equipment and systems undertook IQ/OQ/PQ procedures prior to utilization.
Clinic staff will undertake a series of familiarization, training and safety scenario sessions in the weeks up to and including March 17.
Pharmacy activities will continue at Springfield House until Q3/Q4 2023. Drug product will be transferred from our current GMP pharmacy at Springfield House to Drapers Yard via a validated process ensuring security and storage conditions are maintained during the transfer.