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Some establishments in our remit need to hold a HTA licence to carry out their work. We assess these establishments against regulatory requirements when they first apply to the HTA for a licence and then we inspect the establishment on a site visit to check the regulatory requirements have been...
Inspections are scheduled based on risk. Regulation managers use their professional judgement and assess information. We calculate risk each time we are in receipt of information about an establishment in our remit (e.g. after receiving a licence application or after previous inspections).
Where the HTA determines that a licensing standard is not met, the improvements required are stated and the level of the shortfall is classified as ‘Critical’, ‘Major’ or ‘Minor’.
Directions require the DI and Licence Holder to improve ways of working so that standards are met. It is mandatory for these directions to be followed straightaway.
Inspection reports detail background information about the activities the establishment is carrying out and an indication of any shortfalls in meeting the HTA standards. In addition there are several appendices to the report:
HTA-licensed establishments are required to meet our standards. The standards fall into four broad categories:consent governance and quality systems premises, facilities and equipment disposal
The full list of standards is outlined in Appendix 3 of the inspection report.
Yes. Once the report has been drafted it will be sent to Designated Individuals (DIs) and Licence Holders to check for factual accuracy.
You can contact a Regulation Manager on 020 7269 1900 or email firstname.lastname@example.org
Prior to the introduction of PPDs, we found significant variability in establishments understanding of what is required to validate preparation processes satisfactorily. The PPD aids clarity as it sets out a format for the information you will need to collect, and will help you fill any gaps in...
New licence applications for processing of tissue or cells for human application must include a PPD to describe the process validation. Processing of the tissues and cells cannot commence until the processes proposed under a new licence have been authorised. We also require new or modified...