Practical GxP tips & glossary – free GxP dictionary download

Publicerades 2025-11-21

Working in life science, pharma, cleanrooms or food safety means navigating strict standards, documentation requirements and a wide range of technical terminology. Since these terms are typically used in English throughout the industry, this page and the downloadable dictionary are provided in English only.

Here are a few examples of common abbreviations and concepts, terms that many of us encounter in our daily work and featured in the full Testo GxP Dictionary (100 pages).

21 CFR Part 11 — Electronic records & signatures

Key criteria for when electronic records and signatures are considered equivalent to paper — important for any computerized system used in regulated environments.

GMP (Good Manufacturing Practice)

The core rules for manufacturing and quality assurance in pharma — “cGMP” emphasises keeping them up to date.

Cleanroom

What a cleanroom is, how classes (ISO / A–D) are defined and why pressure cascades and particle limits matter in practice. Useful when planning monitoring and acceptance tests.

Compliance

Simple: conformity to laws, directives and guidelines (e.g. EU GMP). Use this as the baseline for process and documentation checks.

GxP (Good x Practice)

Umbrella term for GMP, GLP, GCP etc. — handy shorthand when discussing cross-discipline QA.

HACCP

Risk-based preventive system for food safety — often used as precursor thinking for pharma/clean environment hazard control.

Validation

Documented proof that a process or system reproducibly meets predefined specifications — covers IQ/OQ/PQ and life-cycle approaches.