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The list below gives examples of how Designated Individuals could seek assurance the premises at which the third party activity takes place is appropriate for the activity.
Yes. Where the third party carries out processing, regular full audits should be carried out at least at two yearly intervals. In addition, and applicable to all activities carried out under the TPA, the Designated Individual must be allowed access to the RTPPs and relevant...
The reporting requirements relating to third parties carrying out licensable activities under the terms of a TPA are set out in paragraphs 232-235 of the
All documentation and records to facilitate the traceability of donors must be retained for 30 years after the cells are used or disposed of.
It is the responsibility of the Designated Individual of the licensed establishment to communicate information to third parties, including regulatory alerts and other relevant communications from the HTA regarding serious adverse events and reactions.
The requirements and procedures for reporting adverse events and reactions that occur at third parties should be clearly documented.
The Designated Individual of the licensed establishment is responsible for assessment and documentation of the adverse incident occurring under the licence and reporting of any serious adverse event or reaction to the HTA and any other affected establishments.
The Designated Individual...
The establishment and the third party must make available to the HTA (on request) all records related to a SAEAR and aid in any investigation process. This process must be clearly specified in the TPA.