GLOSSARY

GMP - Good Manufacturing Practice
That part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or Clinical Trial Authorisation. The principles of GMP are outlined in EU Directive 2003/94/EC and guidelines published by the EU Commission.

GCP - Good Clinical Practice
An international ethical and scientific quality standard for the design, conduct and record of research involving humans. The principles of GCP are outlined in EU Directive 2005/28/EC

CRO - Contract Research Organisation
A company that offers clients pharmaceutical research services, including product development and formulation, clinical trial management, laboratory services, and preparation of regulatory submissions.

SOP - Standard Operating Procedure
A written set of instructions which ensure that specific tasks are carried out in a consistent way. GMP and GCP regulations require companies to have comprehensive sets of SOP's.

QP - Qualified Person
A person who meets educational and experience requirements detailed in EU Directive 2001/83/EC. All holders of Manufacturer's Authorisations in the EU must have at least one QP permanently and continuously available. QP release is required for each batch of product sold or used in a clinical trial in the EU

IMP - Investigational Medicinal Product
The dosage form to be tested in a clinical trial, along with any placebo or comparator products

API - Active Pharmaceutical Ingredient
The internationally agreed description of a drug substance which is to be used to manufacture a drug product for administration to patients

MHRA - Medicines & Healthcare Products Regulatory Agency
The UK licensing authority for pharmaceutical products and medical devices

EMEA - European Medicines Evaluation Agency
The EU licensing authority for pharmaceutical products

FDA - Food & Drugs Administration
The US licensing authority for pharmaceutical products

ICH - International Committee on Harmonisation
The international body responsible for harmonising worldwide regulatory requirements for pharmaceuticals

WHO - World Health Organisation
A specialized agency of the United Nations that acts as a coordinating authority on international public health.