Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
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
Regional Pharmaceutical Quality Assurance Service
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
Regional Pharmaceutical Quality Assurance Service
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)
Regional Pharmaceutical Quality Assurance Service
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
Regional Pharmaceutical Quality Assurance Service
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
Regional Pharmaceutical Quality Assurance Service
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
Regional Pharmaceutical Quality Assurance Service
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
Regional Pharmaceutical Quality Assurance Service
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
Regional Pharmaceutical Quality Assurance Service
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
Regional Pharmaceutical Quality Assurance Service
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
Regional Pharmaceutical Quality Assurance Service
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
Regional Pharmaceutical Quality Assurance Service
QP Involvement
The QP has involvement from the initial requests through pre-trial manufacture, manufacture and right through the duration of the trial.
Regional Pharmaceutical Quality Assurance Service
Future Advanced Therapies? Novel products? Chemotherapy?
Do I have the expertise to act as a QP for
this trial?
Regional Pharmaceutical Quality Assurance Service
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!