Product Approval Accreditation Programme is a national training course that has been developed to deliver a functional and high-quality training and assessment programme for individuals who carry out the task of “product approval” for aseptic products, prepared within hospital pharmacies under section 10 exemption from the Medicines Act 1968.
The programme addresses the training requirements of both pharmacists and suitably trained and experienced, registered pharmacy technicians. As a result, the accreditation must be applied alongside an operating framework that ensures that pharmacist supervision and other governance and safety requirements are fulfilled.
Note that for pharmacists to go forward in the training and assessment programme there are no site specific criteria as participation is encouraged from all Aseptic Services units. For a unit wishing to go forward with Accredited Pharmacy Technician Product Approvers then the following will apply:
The site is approved by their Regional QA specialist / EL Auditor who will consider the following criteria:
The following criteria will apply:
The following will apply:
Each trainee must be approved by the Accountable Pharmacist ahead of registration onto the programme.
The Educational Supervisor can be:
Educational supervisors must be approved by the Chief Pharmacist and Accountable Pharmacist.
It is recommended that the educational supervisor is someone who has the opportunity to meet regularly with the trainee to discuss progress and give feedback.
* For those very experience pharmacy technicians that do not hold a Nationally Recognised PIPC accreditation but have undergone in-house training and are performing the role on a regular basis, there is currently a two year transition period (May 2021 till May 2023) where prior learning and previous checking experience may be taken into account as a route of entry onto the programme.
The ‘Transitional Period for the Recognition of Prior Learning and Previous Checking Experience for Registration onto the Programme (May 2021 till May 2023)Guidance for Pharmacy Technicians’ document outlines the requirements for pharmacy technicians that have not undertaken a nationally recognised PIPC accreditation. A link to this document can be found in the Useful Links sections of this page.
This programme applies to section 10 aseptic services final product approval, including cytotoxic, biopharmaceuticals, parenteral nutrition and CIVAs products
Intrathecal products can be included as long as the final product approver is trained, competent and named on the intrathecal register for this task.
With suitable additional training this can be extended to cover final product approval of Clinical Trials under Paragraph 37 of the Clinical Trials Regulations where the medicines used are licensed products (but not for novel IMPs).
Subject to suitable training and understanding of the status and requirements to the release of outsourced named-patient ready-to-administer products.
Products made in anticipation of a prescription cannot be released until matched with a verified prescription
Exclusions from the process
The process applies to aseptically prepared pharmaceuticals only and with the following exemptions:
Self directed learning, Online Induction
Pre-induction assessment / evidence collection and competency based assessments / e-portfolio regional assessment / local exam and knowledge based assessment / online panel assessment
Programme content access is restricted by password.
To access the content, click below and enter your password to continue.
If you do not have a password, please contact your course director for access.
Answers to most common applications for each stage of the Programme process can be found on our Frequently Asked Questions page and is usually the quickest and easiest way to resolve most enquiries.
Please ensure you check this page before submitting a contact enquiry.
Product Approval Accreditation Programme – Transitional Period for the Recognition of Prior Learning and Previous Checking Experience for Registration onto the Programme (May 2021 till May 2023) Guidance for Pharmacy Technicians
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