qualified persons (imp) - nictu · 2016. 5. 6. · qualified persons (imp) don wallace regional qa...

Qualified Persons (IMP)

Don Wallace Regional QA Pharmacist

27th May 2014

Regional Pharmaceutical Quality Assurance Service

Introduction EU Clinical Trials Directive 2001 came into

existence in the UK in May 2004 (Part 6 – Manufacture of Investigational Medicinal Products (IMPs))

Must be complied with by 2006 - Require an IMP licence granted by MHRA to

manufacture batches of product - A QP is required to release batches of IMPs


NHS Position • Many NHS manufacturing facilities applied

for IMP licences • Under the transitional arrangements,

personnel involved in releasing batches of clinical trials materials prior to the introduction of the legislation provided information together with a supporting CV to the MHRA to be named as a QP (IMP) on the licence


NHS Position Survey performed in 2010 - Approx. 40 NHS sites (14 Radiopharmacy) - Approx. 70 QPs (35 under transitional

arrangements). 10 retiring within next 10 years

Northern Ireland - 1 NHS IMP site (Victoria Pharmaceuticals) - 3 QPs (2 RPQAS, 1 WHSCT)


New QPs • Must become a full QP - Pharmacist, Microbiologist, Chemist through

respective professional bodies. - Extensive and relevant experience working

in pharmaceutical industry. - Extensive knowledge through study;

formulation, microbiology, statistics, clinical trials, APIs, law, etc.

- Viva


RPQAS (services to VP) Regional Pharmaceutical QA Service

Victoria Pharmaceuticals

QP Services Microbiological Testing

Documentation Approval

Chemical analysis

Sterility testing

Co-ordinate QMS

QA Service Audit


Requests • We have a drug that needs labelled

(overlabelled) • We need a supply of active and placebo

capsules/tablets • We require stock of a product for a

multicentre trial • We have a trial material that is being made

up on a lab bench and we wish to scale up manufacture to supply in a clinical trial


Roles and Responsibilities of QP Pre- manufacture (GCP) Has a general overview of the complete trial;

including conversant with trial protocol Attends meetings; partakes in conference calls;

with investigators/sponsors/R&D/CT personnel Ensures that all authorisations and documentation

is complete prior to manufacturing the first batch of trial material

Reviews and approves trial documentation prior to manufacture, e.g. TAs, Product Specifications


Pre-manufacture (GMP) • Assures formulation of the product is appropriate • Ensures the stability of the product plus assigned

expiry • Ensures the quality of the starting materials and

packaging components • Assesses starting materials documentation (C of

As, TSE compliance, Imported products docs, SmPCs)

• Approves all production and QC documentation


Batch Production Provides QP release certificates for all

batches Ensures that the products released are fit for

their intended purpose Ensures that all aspects of manufacture

comply with GMP For complex randomisation, blinding and

labelling activities, supervises the labelling process


General In depth knowledge and understanding of

manufacture and distribution Audits of external suppliers Internal audits of manufacturing areas Deals with customer issues Co-ordinates recalls Ensures temperature compliance during

storage and transport


General Keeps up to date with legislation and

training requirements Gains relevant knowledge of new products

prior to involvement as a QP Participation in regulatory inspections(MHRA) Deals with general queries about the

products Liaises with other QPs


QP Involvement

The QP has involvement from the initial requests through pre-trial manufacture, manufacture and right through the duration of the trial.


Future Advanced Therapies? Novel products? Chemotherapy?

Do I have the expertise to act as a QP for

this trial?


Questions Later!

Qualified Persons (IMP)IntroductionNHS PositionNHS PositionNew QPs RPQAS (services to VP)RequestsRoles and Responsibilities of QP �Pre- manufacture (GCP)Pre-manufacture (GMP)Batch ProductionGeneralGeneralQP InvolvementFutureQuestions Later!

qualified persons (imp) - nictu · 2016. 5. 6. · qualified persons (imp) don wallace regional qa...

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