ENGINEERING PHARMACEUTICAL INNOVATION
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What our members say

The unique combination of ISPE's common sense and global presence will make us able to work with regulators throughout the world, as well as small and big companies worldwide. We can combine global presence and global strength with ISPE's abilities to integrate this into people's daily lives.

Gert Moelgaard, Vice President
NNE, Denmark

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True Stories: What it means to be an ISPE Member - (WMV, 16 MB) (Click to begin, or right-click to download and view later)

Regulatory Resources
Regulatory Agencies: European Acronyms
ABPI
Association of British Pharmaceutical Industries
API
Active Pharmaceutical Ingredient
BGA
Institute für Arzneimittel des Bundergesundheitsamtes (German Health Authority)
BMA
British Medical Association
BP
British Pharmacopoeia
BSE
Bovine Spongiform Encephalopathy (Mad Cow disease)
CEFIC
European Council of Chemical Industries Federation
CEN
Comité Européan des Normes (European Committee for Standardization)
CIA
UK Chemical Industries Association
CPMP
Committee on Proprietary Medicinal Products
CVMP
Committee on Veterinary Medicinal Products
DQ
Design Qualification
DG
Directorate General
DIA
Drug Information Association
EC
European Commission
EFPIA
European Federation of Pharmaceutical Industries Associations
EFTA
European Free Trade Association
EMEA
European Agency for Evaluation of Medicinal Products
EOQ
European Organization for Quality
EP
European Pharmacopoeia
EU
European Union
GCP
Good Clinical Practice
GCLP
Good Control Laboratory Practice
GLP
Good Laboratory Practice
GMP
Good Manufacturing Practice
HEPA
High Efficiency Particulate Air
HVAC
Heating, Ventilation and Air Conditioning
ICH
International Conference on Harmonization
IFPMA
International Federation of PharmaceuticalManufacturers Associations
IMB
Irish Medicines Board
IMP
Investigational Medicinal Product
IQ
Installation Qualification
LAF
Laminar Air Flow
LAL
Limulus Amoebocyte Lysate
MCA
Medicines Control Agency (UK)
MRA
Mutual Recognition Agreement
OQ
Operational Qualification
OTC
Over-the-counter (Medicine)
PICS
Pharmaceutical Inspection Cooperation Scheme
PQ
Process Qualification
QA
Quality Assurance
QC
Quality Control
QP
Qualified Person
WHO
World Health Organization
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