Worklist for Issue of frozen products for as starting material for manufacture

Receipt, storage & issue of advanced therapies

Receipt, storage & issue of advanced therapies

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16/11/2020

Cellular ATMP cryopreserved allogeneic example receipt checklist

This document sets out an example generic checklist for allogeneic, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs).
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18/11/2020

Cellular ATMP cryopreserved autologous example receipt checklist

This document sets out an example generic checklist for autologous, cryopreserved, cellular Advanced Therapy Medicinal Products (ATMPs)
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18/11/2020

Cellular ATMP fresh allogeneic example receipt checklist

This document sets out an example generic checklist for receipt and storage of fresh, allogeneic, cellular Advanced Therapy Medicinal Products
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19/10/2021

Cellular ATMP fresh autologous example receipt checklist

This document sets out an example generic checklist for receipt and storage of fresh, autologous, cellular Advanced Therapy Medicinal Products.
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11/06/2021

Checklist for receipt of empty shipper

Form to complete when receiving, processing and releasing fresh cells for manufacturing
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15/09/2021

Checklist for receipt of frozen product

A checklist to confirm ATMP is received appropriately from the manufacturer prior to administration to a patient
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18/10/2021

Competency Assessment: Safe use of dry shippers and/or dry ice

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.
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pdf
16/11/2021

Disposal of IMP or ATMP Product

Form to be completed on the disposal of IMP or ATMP
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Online Article
28/11/2022

ISBT 128 labels for advanced therapies – eLearning Module

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user an overview of the requirements for labelling human tissues and cells for use as starting materials for advanced therapy medicinal products using the ISBT 128 system.

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pdf
05/04/2021

Issue of IMP or ATMP Product

Checklist to be completed on the issue of IMP or ATMP
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Online Article
14/11/2022

Outsourcing of Storage or Preparation of ATIMPs Across Legal Boundaries

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.
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pdf
03/08/2020

Receipt processing and release of fresh cells as starting material for manufacture

Form to complete when receiving, processing and releasing fresh cells for manufacturing
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06/04/2021

Self Assessment questionnaire to perform the storage and release of ATMPs on behalf of Pharmacy

Self-assessment questionnaire to assess regulatory compliance in The Christie Pathology Partnership Laboratories to perform the storage and release of ATMPs
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27/02/2023

SOP: Infusion of cellular products

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.
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29/01/2021

Stem Cell Lab Visit Report – Pharmacy Monitoring Form

An audit template for the oversight of pharmacy with the stem cell laboratory for the storage and handling of ATMPs
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  • Advanced therapy clinical trials process overview

    Advanced therapy clinical trials process overview

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    This section features The NIHR Clinical Trials Toolkit and The ABPI ATMP road map

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  • Trial Governance

    Trial Governance

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    Information regarding the governance arrangements required within the NHS to approve, set up and manage clinical trials of advanced therapy investigational products is included here, with details on local governance, committees, feasibility and risk assessments.

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  • Procurement of Starting Materials

    Procurement of Starting Materials

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    Information and considerations during the collection of starting materials for the manufacture of advanced therapies can be found here, including model SOPs in relation to:

    • Solid tumours A suite of SOPS by cancer type relating to sample collection for isolation of tumour-infiltrating lymphocytes (Tils)
    • Blood (aphaeresis) A suite of SOPS for adoptive cellular therapy (Immune Effector Cells)

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  • Receipt, storage & issue of advanced therapies

    Receipt, storage & issue of advanced therapies

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    Available here are examples of checklists and templates for the safe receipt, storage and issue of advanced therapies within the NHS.

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  • Pharmacy considerations

    Pharmacy considerations

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    The considerations for hospital pharmacy departments delivering advanced therapies, including:

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  • Clinical management of patients at site

    Clinical management of patients at site

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    Includes exemplar SOPs and information regarding the clinical management of patients receiving advanced therapies in a hospital setting, covering patient consent, treatment, management of toxicities and follow-up care.

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  • Education and training

    Education and training

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    This section includes links to webinars, e-learning modules and a range of resources, to assist all staff delivering advanced therapy trials in an NHS setting.

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  • Performance management and metrics

    Performance management and metrics

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    An outline of the barriers to effective advanced therapy clinical trial set up, changes to overcome these barriers, and the key metrics to measure success in terms of trial set up and patient referral and recruitment is available here.

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  • National infrastructure, templates and guidance

    National infrastructure, templates and guidance

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    Links to information on the national infrastructure surrounding the clinical trial application process, also further guidance, and templates to assist in the set up and delivery of advanced therapy clinical trials. Including examples of model ATiMP clinical trial agreements.

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    • Explore all toolkit sections

  • Governance

    Governance

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    This section is intended to assist NHS organisations to create or modify governance structures to permit the introduction of advanced therapies, encompassing all levels of governance responsibilities and reporting within hospitals.

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  • Business and financial planning

    Business and financial planning

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    The introduction of advanced therapies into hospital treatment pathways requires a significant financial investment in resources and facilities. Information available here will help organisations to develop the appropriate business and financial plans as they prepare to deliver advanced therapies.

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  • Quality assurance and risk management

    Quality assurance and risk management

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    This section provides examples of, and guidance on, the implementation of quality systems and risk assessments for safe delivery of advanced therapies towards preparing for regulatory inspections.

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  • Operational delivery

    Operational delivery

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    The documents in this section will assist in the implementation of new advanced therapy services in a clinical setting, supporting the transition of guidance into practice.  Documents include process and patient flow charts to map the treatment pathway and information on the in-hospital logistics requirements.

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  • Clinical practice

    Clinical practice

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    Information is available here to support the clinical practice of the delivery of advanced therapies to patients, including patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.

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  • Education and training resources

    Education and training resources

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    To safely deliver advanced therapies to patients, staff need to be trained in this new modality of therapeutic intervention. This section includes resources that enable staff to learn more about ATMPs including e-learning, facilitating face to face training and competency assessments, and materials to support patient education.

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  • Long term follow up

    Long term follow up

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    A regulatory feature of advanced therapies is the need for longer-term follow up than for other therapeutic modalities.  The information provided here speaks to the methods of data collection for extended follow up patients after treatment.

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  • Clinical trials

    Clinical trials

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    This section has a range of resources – split into 8 sub-sections – which will assist NHS sites to prepare for the set up and delivery of advanced therapy clinical trials. Its objective is to disseminate learnings from the ATTCs regarding the governance, infrastructure and processes which underpin successful trial set up and delivery.

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