Nationally Recognised Competency Framework
for Pharmacists and Pharmacy Technicians:
The Assessment of Product Approval (Release) in Aseptic Services
under Section 10 exemption


The nationally recognised competency framework for the training, assessment and accreditation of individuals carrying out the role of Product Approval (release) in aseptic services, under section 10 exemption has been developed by the NHS Aseptic Services Accreditations Working Group (NHS ASAG) in conjunction with the South West Medicines Information & Training (SWMIT) Product Approval Pilot Project*. The national working group includes Regional Quality Assurance Officers, pharmacists and pharmacy technician specialists and education and development specialists representing many regions within the United Kingdom. The approval of any programmes through this framework will be carried out under the authority of NHS ASAG.

*More information on the SWMIT Product Approval Pilot Project can be found within the Evaluation Report which can be downloaded at

This framework outlines the processes that must be followed for the training and assessment of pharmacists and pharmacy technicians involved in an accreditation programme, and supersedes the previous ‘Nationally Recognised Framework for Accreditation of Final Accuracy checking within Aseptic Services’ published in Oct 2008.

The aim of the National Framework for the Assessment of Product Approval (Release) is to:

  • Enable training providers to develop and implement a fit for purpose training and assessment programme that will deliver enhanced skills, knowledge, and an appropriate level of confidence for pharmacists and pharmacy technicians to approve products prepared in aseptic services under Section 10 exemption of the Medicines Act (1968)
  • Support appropriate skill mix within pharmacy aseptic services units
  • Enable training providers to provide a nationally recognised and transferrable accreditation to successful candidates.

The national framework is open to all organisations wishing to use pharmacists and pharmacy technicians to undertake the task of product approval (release) of aseptically prepared products under section 10 exemption.

How to get a Product Approval Training Programme approved

Any training provider wishing to develop and deliver a Product Approval training and assessment programme can apply to have their programmes mapped against the standards of the national framework and be approved nationally under the authority of the NHS Aseptic Services Accreditations Group. The approval panel members are occupational experts who have been designated by NHS ASAG.

Before a programme is submitted for approval, the programme lead must have assessed whether the programme fulfils the criteria of the framework. The submitted programme will then be assessed against criteria based on learning outcomes, resources and training delivery, and methods of assessment.

There is a fee of £300 per application. An invoice for payment will be issued when your application is received.

For more information on the programme approval process, please refer to the approval application pack and the approval process map.

The dates of the upcoming approval meetings are:


Key documents (with links)


For more information on the framework or for help and guidance on completing the application form, please contact your nearest regional representative of the NHS Aseptic Services Accreditations Working group (NHS ASAG).


Members of NHS ASAG


Regional QA Specialist

Richard Bateman

East and South East England Specialist Pharmacy Services

Regional QA Specialist

Alison Beaney

North East & North Cumbria

Regional Quality Assurance

Mark Santillo

South West region

Accountable Pharmacist

Paul Spark


Accountable Pharmacist

Oonagh McGrath

University Hospitals Bristol NHS Foundation Trust

Regional Specialist Pharmacist, Education and Training

Helen Fawcett

North East & North Cumbria

Operations Manager

Gill Robson

Newcastle Specials & Pharmacy Production, Royal Victoria Infirmary
Newcastle upon Tyne

Education and development Pharmacy Technician

Sally Kemp (up to 09/11)

Ellen Williams (from 09/11)

South West Medicines Information & Training (SWMIT)  

Director of SWMIT

Trevor Beswick

South West Medicines Information & Training (SWMIT)