The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
Specification
A list of tests, references to analytical procedures, and appropriate acceptance criteria
Acceptance Criteria
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures
Qualified Person (QP)
It is a legal requirement for every manufacturer of pharmaceutical products to have a Qualified Person. Assuring the quality of…
Good Manufacturing Requirements (GMP)
Good Manufacturing Practice. This is a recognised standard for pharmaceutical processing and manufacture ensuring medicinal products are consistently produced and…
MA (Marketing Authorisation)
Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in…
CND (and EMDN)
The CND (Classificazione Nazionale Dispositivi medici), developed by the Italian Ministry of Health, is an alternative system to GMDN and…
GMDN – Global Medical Device Nomenclature.
GMDN is a comprehensive set of terms that provides generic descriptors for the identification of all medical device products, comprised…
UDI – Unique Device Identifier
A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that…