A2LA The American Association for Laboratory Accreditation
AAALAC The Association for Assessment and Accreditation of Laboratory Animal Care
AAMI Association for the Advancement of Medical Instrumentation
ADME Absorption, Distribution, Metabolism and Excretion
ADR Adverse Drug Reaction
AE Adverse Event
ANSI American National Standards Institute
AOAC The Scientific Association Dedicated to Excellence in Analytical Methods
API Active Pharmaceutical Ingredient
ASMF Active Substance Master File
ASTM Standards
BAM FDA's Bacteriological Analytical Manual
BDP Bulk Drug Product
BP British Pharmacopoeia
BPCRS British Pharmacopoeia Chemical Reference Substances
CAP College of American Pathologists
CEN European Committee for Standardization
CFR Code of Federal Regulations
CLIA Clinical Laboratory Improvement Amendments
CPMP Committee for Proprietary Medicinal Products for Human Use
CRF Case Report Form
CSM Committee on Safety of Medicines
CTC Clinical Trial Certificate
CTX Clinical Trial Certificate of Exemption
DBDD Double Blind Double Dummy
DMF Drug Master File
EDQM European Directorate for the Quality of Medicines
EMEA European Medicines Evaluation Agency
FDA Food and Drug Administration
FPP Finished Pharmaceutical Product
GCP Good Clinical Practice
GLP Good Laboratory Practices
GMP Good Manufacturing Practice
GSP Good Supply Practice
ICH International Conference on Harmonization
IDB Investigators’ Drug Brochure
IEC Independent Research Ethics Committee
IEEE IEEE Standard Association
ISO International Standards Organization
MAA Marketing Authorisation Approval
DMF Drug Master File
MHRA Medicines and Healthcare Products Regulatory Agency
MREC Main Research Ethics Committee
NCE New Chemical Entity
NICE National Institute of Clinical Excellence
NVLAP National Voluntary Laboratory Accreditation Program
OOS Out Of Specification
P Pharmacy Only Medicine
PIL Patient Information Leaflet
PMS Post Marketing Surveillance
POM Prescription Only Medicine
PPRS Pharmaceutical Price Regulation Scheme
PQIF Pharmaceutical Quality Information Form
QA Quality Assurance
QC Quality Control
QWP Quality Working Party
REACH European Community Regulation on chemicals and their safe use
RoHS Restriction of the use of certain hazardous substances in electrical and electronic equipment
SAE Serious Adverse Advent
SAMM Safety Assessment of Marketed Medicines
SDV Source Data Verification
SOP Standard Operating Procedure
UKAS United Kingdom Accreditation Service
UL Underwriters Laboratories
USP United States Pharmacopeia
WEEE Waste Electrical and Electronic Equipment