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
glossary
Quality Overall Summary (QOS)
An element of drug marketing applications, which provides a substantially condensed summary of the quality-related data provided within the submission.…
glossary
Module 3
This is the quality (or CMC) module, which is a component of the common technical document used for the registration…
glossary
Critical Process Parameter (CPP)
A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled…
glossary
Critical Quality Attribute (CQA)
A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to…
glossary
Comparability Protocol
A comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change on the identity, strength, quality,…
glossary
Chemistry, Manufacturing, and Control (CMC)
A critical aspect of pharmaceutical development processes and applications. CMC includes bulk drug substance chemical and physical properties, bulk drug…
glossary
Specification
A list of tests, references to analytical procedures, and appropriate acceptance criteria
glossary
Acceptance Criteria
Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures
Resources 