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Contents
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Why?
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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Draft Guidance for PET Drug Products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
19 annexes
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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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Clinical Trials
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SOPs
Performance of the
Study
Reporting of Study
Results
Storage and Retention
of Records and
Materials
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Introduction
Purpose
Personnel
Premises
Equipment
Guidelines
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Production
Storages
Complaints
Follow up
Annexes
16
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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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Storage
Distribution
Intranet
Update
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GPP-group
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