Quality System in

Turku PET Centre

PET Basics Course 2006

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Contents

General about quality systems

GMP, GCP, GLP
Quality system in Turku PET Centre (TPC)
Clinical trials at TPC

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What Quality Standard?

GMP = Good Manufacturing Practice

GCP = Good Clinical Practice
GLP = Good Laboratory Practice
ISO Standards (e.g. ISO 9000, ISO 14 000)
etc.

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Why?

Mandatory (laws, authorities, customers)

Reliability, traceability
International comparability
Marketing tool

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GMP
Good Manufacturing Practice for medicinal
products
Those arrangements in production and
quality assurance, which ensure that
medicinal products fulfil all the
specifications set

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GMP
1992 GMP became legal in Finland
2002 Drug law 14 (hospital pharmacies)
National Agency for Medicine (NAM):
Administrative regulation 12/2002
EU directive 91/356/ETY and the
supplementary Guide to Good Manufacturing
Practice for Medicinal Products
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GMP-guides
EU (http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm)
FDA
Draft Guidance for PET Drug Products
(http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-0266gdl0002.pdf)

PIC/S (http://www.picscheme.org/BAK/pubs/pubs.htm )
WHO etc.
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Contents of EU GMP-guide
Quality Management
Personnel
Premise and
Equipment
Documentation
Production
Quality Control

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Contract Manufacture
and Analysis
Complaints and
Product Recall
Self Inspections
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Annexes e.g.
Manufacture of Sterile Medicinal Products
(annex 1)
Manufacture of RadioPharmaceuticals
(annex 3)
Manufacture of Investigational Medicinal
Products (annex 13)

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Good Clinical Practice (GCP)

International ethical and scientific quality
standard for designing, conducting,
recording and reporting trials that involve
the participation of human subjects
Assurance that the rights, safety and wellbeing of trial subjects are protected

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Clinical Trials

Drug law 15a and 87

Law for medical trials (488/1999, 986/1999)
NAM: Administrative regulation 2/2004
ICH Harmonised Tripartite Guideline for
Good Clinical Practice (2002)
World Medical Association: Declaration of
Helsinki
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Contents of ICH GCP-guideline

Investigator
Sponsor
Clinical trial protocol and protocol
amendments
Investigators brochure
Essential documents for the conduct of a
clinical trial
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Good Laboratory Practice (GLP)

Quality system for non-clinical health and
environmental safety studies
OECD principles adopted originally 1981,
revised 1998
EU directive 1999/11/EY
(http://www.utu.fi/erill/kek/glpsu.htm#sis )

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Contents of OECD GLP-principles

Organisation and
Personnel
Quality Assurance
Facilities
Apparatus, Materials
and Reagents
Test Systems
Test and Reference
Items
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SOPs
Performance of the
Study
Reporting of Study
Results
Storage and Retention
of Records and
Materials

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Quality System of TPC

Site Master File

SOPs
METs
GPP-group

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Site Master File

Introduction
Purpose
Personnel
Premises
Equipment
Guidelines

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Production
Storages
Complaints
Follow up
Annexes

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SOPs and METs

SOP = Standard Operation Procedure

MET = Method Description
Coded: SOPxxxx and METxxxx
Grouped by the subject

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SOPs and METs

SOPs

General
IT
A, Cyclotron
Radiochemistry
PET-TUH
PET-MediCity

SOP7000 SOP7099
SOP7100 SOP7199
SOP7400 SOP7449
SOP7450 SOP7499
SOP7500 SOP7599
SOP7600 SOP7699

METs respectively
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SOPs and METs

Storage
Distribution
Intranet
Update

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GPP-group

GPP = Good PET Practice

13 members
Meeting every 1.5 months
Current quality related issues

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Clinical Trials at TPC

Three options:
Academic study (TPC/research group)
Study sponsored by a pharmaceutical
company
Contract Research Organization (CRO e.g.
CRST)

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Permissions for the study

TPC (Scientific Project Group)

Ethical committee
NAM
TUH

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Study Register of TPC

Study plan and its amendments (with
appendices)
Application, decision and correspondence
Ethical committee
NAM
TUH

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