Product Approval Accreditation Programme

The Product Approval Accreditation Programme consists of:

• Site approval by regional QA Officer (necessary for pharmacy technician applicants only, see further entry requirements below)
• Candidate pre-course assessment (to be completed prior to attendance at induction)
• Local viva voce carried out by the Accountable Pharmacist
• Self-assessment
• Written assessment of knowledge
• Completion of pre-induction activities
• Online induction (full day)
• Period of work based evidence collection and portfolio build
• Candidate post course summative assessment 
• Summative practical assessment
• External regional panel viva voce 
• Self-assessment 
• Written assessment of knowledge

The course is open to applications from across the United Kingdom.

Entry Criteria

Entry Criteria for Participating Sites

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 able and willing to operate the required pharmacist supervision model
• The site has a commitment from the Chief Pharmacist and Accountable Pharmacist to approve and support trainees to undertake training
• The Accountable Pharmacist must have sufficient experience and understanding of the legal issues and the model for supervision
• The site is approved by their Regional QA specialist / EL Auditor who will consider the following criteria:

a)           All relevant SOPs are in place and all worksheets approved by the Accountable Pharmacist

b)           Risk Management arrangements are satisfactory including robust change control processes

c)           Suitable staff training programmes and resources are available

d)           Clinical checking by accredited pharmacists and prescription verification is carried out by Authorised Pharmacists¹

e)           A robust in-house system of dealing with errors including monitoring, reporting, managing and trending of errors is in place and the reviewing of data from the National Error Reporting Scheme. Sites should report to the National Error Reporting Scheme

              There must be data to support the baseline error rate. Error rates must be part of the acceptance criteria for the Change Control when introducing the change to allow accredited pharmacy technicians to carry out final product approval

f)            Robust Quality Management Systems, including deviations and untoward events reporting and investigation are in place

g)           The management structure is compliant with the nationally agreed definition of supervision.

Entry Criteria for Pharmacists

The following criteria will apply:

The pharmacist is allocated to an aseptic unit for a suitable minimum period of time sufficient to complete the programme (3 months). 

The individual should be committed to the process

Entry Criteria for Pharmacy Technicians

The following will apply:

The registered pharmacy technician is allocated to an aseptic unit for a suitable minimum period of time sufficient to complete the programme (3 months).

They should have least 2 years full-time or 3 years rotational aseptic experience and be accredited in line with the national framework, to perform pre & in-process checks in aseptic preparation.

The individual should be committed to the process.

Accountable Pharmacist Approval

Each trainee must be approved by the Accountable Pharmacist ahead of registration onto the programme.

Who can be the Educational Supervisor?

The Educational Supervisor can be:

• The Accountable Pharmacist or an experienced and designated authorised pharmacist based in the trainee’s unit

or

• An experienced accredited product approver

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.

Scope of the framework

This programme applies to section 10 aseptic services final product approval, including cytotoxics, 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:

1. Radiopharmaceuticals
2. Products made under MS or MIA (IMP) licences
3. One off products made without a fully approved worksheet
4. Advanced Therapy Medicinal Products