We inspect establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 at least every two years.
We need to be satisfied that the Designated Individual (DI) is suitable to supervise the activities covered by the licence. We also need to be satisfied that the licence applicant or holder, the establishment’s premises, and the practices relating to licensed activities, are suitable.
To help us reach our decisions, we have developed licensing standards under four categories:
- Governance and Quality;
- Premises, Facilities, and Equipment; and
After every site visit inspection, we write a report documenting our findings. Where we find a particular standard is not met, we will describe the level of the shortfall as ‘Critical’, ‘Major’ or ‘Minor’.
Following an inspection cycle, we sometimes find shortfall trends or themes across a number of establishments. We plan to highlight some of these areas and provide further guidance to help you remain compliant ahead of an inspection.