PDF
16.11.2020
This document sets out an example generic checklist for allogeneic, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs).
PDF
18.11.2020
This document sets out an example generic checklist for autologous, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs)
PDF
18.11.2020
This document sets out an example generic checklist for receipt and storage of fresh, allogeneic, cellular Advanced Therapy Medicinal Products
PDF
19.10.2021
This document sets out an example generic checklist for receipt and storage of fresh, autologous, cellular Advanced Therapy Medicinal Products.
PDF
11.06.2021
Form to complete when receiving, processing and releasing fresh cells for manufacturing
PDF
15.09.2021
A checklist to confirm ATMP is received appropriately from the manufacturer prior to administration to a patient
PDF
18.10.2021
This document can be used to help prompt consideration and recording of the competencies that are needed to work safely with dry shippers and/or dry ice.
PDF
16.11.2021
Form to be completed on the disposal of IMP or ATMP
PDF
05.04.2021
Checklist to be completed on the issue of IMP or ATMP
External link
14.11.2022
This guidance produced by the Pan UK Pharmacy Working Group for ATMPs describes the legal basis for associated activity and provides guidance for Pharmacy clinical trial sites who may need to outsource these services. The information provided will guide Pharmacy trial sites in establishing appropriate partnerships and understand the regulatory position with regard to the activities contracted.
PDF
03.08.2020
Form to complete when receiving, processing and releasing fresh cells for manufacturing
PDF
06.04.2021
Self-assessment questionnaire to assess regulatory compliance in The Christie Pathology Partnership Laboratories to perform the storage and release of ATMPs
PDF
27.02.2023
SOP to ensure all nursing and medical staff involved in the infusion of cellular products are aware of their responsibilities, the procedure and any action to be taken in the event of adverse reactions or incident.
PDF
29.01.2021
An audit template for the oversight of pharmacy with the stem cell laboratory for the storage and handling of ATMPs