Please see below for a list of search results.
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.
When major or minor shortfalls have been identified following the inspection site visit, the establishment will be asked to complete a corrective and preventative action (CAPA) plan which outlines the steps that will be taken to address the shortfalls.
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...
As the name implies, PPDs refer only to preparation processes. Procedures used to procure, distribute, store or engraft tissues or cells fall outside the scope of PPDs. Preparation processes include all operations involved in the preparation, manipulation, preservation and packaging of tissues...
In general, packaging and labelling of tissues or cells should be regarded as a stage in the preparation process. There is a specific section of the PPD for you to record labelling and accompanying documentation that must be completed if you are distributing tissues or cells for end use.