1
Scope
Applies to sterile medicinal products; selected principles may also support risk-based control for some non-sterile products.
REGULATORY KNOWLEDGE
EU GMP Annex 1 explained
The complete original European Commission document with structured explanations for sterile manufacturing and contamination control.
Generally applicable since 25 August 2023; point 8.123 since 25 August 2024.Open PDF at the European Commission
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2
Principles
Quality risk management, appropriate technology and a site-wide CCS form the foundation.
3
Pharmaceutical Quality System
Responsibilities, deviations, CAPA, change control and management oversight must work together.
4
Premises
Layout, pressure cascades, material and personnel flows, and barriers should prevent contamination.
5
Equipment
Equipment design, cleaning, maintenance and qualification must match process risks.
6
Utilities
Water, steam, gases, vacuum and cooling systems require risk-based design and monitoring.
7
Personnel
Qualification, behaviour, hygiene and garments are central contamination barriers.
8
Production and technologies
Aseptic and terminally sterilised processes, filtration, BFS, FFS, lyophilisation and closed systems.
9
Environmental and process monitoring
A risk-based monitoring programme links particles, microorganisms, trends, alert levels and process data.
10
Quality Control
Sampling, sterility testing, methods and batch assessment must complement process understanding.
Complete original document
European Commission · 2022 revision
Professional orientation only, not legal or GMP advice. The authority's current original text always prevails.