AstraZeneca's 2024 HTA Inspection Journey

We received notification in May 2024 that we were to be inspected by the Human Tissue Authority (HTA) in relation to AstraZeneca’s research licence. This was to be expected, since we had spent over a year planning and delivering a compliant and risk mitigated process to move over 200,000 human biological samples (HBS) from multiple UK locations into AstraZeneca’s new headquarters, The Discovery Centre (DISC), based on the Cambridge Biomedical Campus.

Our initial call with the HTA was very positive. After a brief introduction with our assigned Regulation Manager, we began to discuss the top-level outlines of AstraZeneca’s HBS operations.  We wanted to convey a feel for the scale and complexity of our organisation and suggest a preliminary schedule for the inspection itself.

AstraZeneca has a global biobank network with the UK regional centre at the Discovery Centre, as well as many research groups from different therapy areas, that collect, use and store samples to support the end-to-end drug discovery and development process.  We currently have 18 research groups storing HTA relevant material, consisting of 29 Persons Designated (PDs) across 8 separate laboratories, that are part of the AstraZeneca global collection of over 5 million human biological samples.

We agreed upon one day of virtual inspection, followed by one day of in-person inspection, as we had completed a full Virtual Regulatory Inspection in 2021, with only minor findings. We felt very at ease with the HTA Regulation Manager who answered our questions comprehensively and was able to allay any concerns that we had about the inspection itself. We also felt that she was very considerate of our situation, since our last HBS-holding research groups had very recently just moved in.

Due to this, the 16 and 17 September were set for the inspection, so that all groups had finalised their moves with time to get themselves properly established in their new laboratories.

To prepare for the inspection, the first job was to complete the self-assessment form. This is not a trivial amount of work, since a great deal of information must be gathered, along with relevant documentation from our internal teams as well as the service providers and Facility Management staff that we work with.

All of this needed to be uploaded into the HTA’s inspection portal. Despite large numbers of documents, including processes, training records, equipment validation information etc, the upload to the portal was relatively quick. HTA’s Regulation Manager was always on hand to answer any questions that we had during this time, which reassured us that we were doing the right thing.

Being ‘always inspection ready’ is an expectation of all organisations, and AstraZeneca is no exception. Our scheduled HBS quality and compliance audits help to ensure this, but in the lead-up to the HTA inspection we were increasing the incidence of these checks, plus undertaking other related activities such as giving staff additional training about what to expect from an inspection, including how to conduct themselves during the inspection.

The actual inspection itself was very well run and a joy to participate in. We worked closely with our colleagues in Quality Assurance, the Biobank, the research teams, and Facility Management, to name but a few. We had staff members in the main inspection room, in an anteroom and ready on call should we need their input. HTA’s Regulation Manager was very friendly and professional, and made us feel at ease throughout. We answered her questions thoroughly, provided evidence of any compliance aspects she requested and helped her to smoothly facilitate HBS traceability checks within our laboratories. Her feedback to us was very favourable, with no official findings to report other than giving us some extremely useful advice around areas for further continuous improvement.

Overall, we found our HTA inspection to be an extremely positive experience and a great benchmark to prove that at AstraZeneca, we are doing the right thing with our HBS / HTA compliance. Our advice to anyone being inspected is not to panic, but to focus on working collaboratively with both the HTA and the various stakeholders within your own organisation towards a favourable outcome. It really was a rewarding team effort.

Dr Kirstin Goldring

Senior Director, Head of HBS Compliance and Governance & DI for AstraZeneca’s HTA Research Licence

and 

Mr Simon Renshaw

Associate Director, HBS Compliance and Governance & PD under AstraZeneca’s HTA Research Licence