EU GMP Annex 1: requirements for air monitoring in pharmaceutical production
EU GMP Annex 1 – Manufacture of Sterile Medicinal Products – is the most important regulatory document for aseptic pharmaceutical production in Europe. The revised version that came into force in 2023 sets even clearer requirements for air monitoring.
What does Annex 1 require for air monitoring?
Annex 1 requires pharmaceutical manufacturers to have a robust Environmental Monitoring Program (EMP) that includes:
- Particle counting – continuous monitoring of non-viable particles ≥0.5 μm and ≥5.0 μm in Grade A and B zones
- Microbial sampling – active and passive sampling of airborne viable particles
- Settle plates – passive monitoring to detect contamination
- Contact plates – surface sampling of critical surfaces
Cleanroom classes according to GMP
| GMP Class | ISO Class (at rest) | Max particles ≥0.5 μm/m³ |
|---|---|---|
| Grade A | ISO 5 | 3 520 |
| Grade B | ISO 5 | 3 520 |
| Grade C | ISO 7 | 352 000 |
| Grade D | ISO 8 | 3 520 000 |
Key points in revised Annex 1
- Contamination Control Strategy (CCS) – requirement for a holistic contamination control strategy
- Data integrity – all measurement data must comply with ALCOA+ principles
- Risk-based approach – monitoring programmes must be based on risk assessment
- Qualification – all instruments must be qualified (IQ/OQ) and calibrated
How we help
We offer particle counting, microbial sampling and cleanroom classification to support your Annex 1 compliance. All measurements are performed with calibrated instruments and documented according to applicable requirements.
Read more about cleanroom air monitoring and calibration.
Frequently asked questions
Yes, EU GMP Annex 1 applies to all pharmaceutical manufacturers within the EU/EEA, including Sweden. The Swedish Medical Products Agency is the supervisory authority.
Grade A zones normally require continuous particle monitoring throughout the aseptic process.
Particle counters that comply with ISO 21501-4 and are calibrated and qualified (IQ/OQ) according to ISPE GAMP 5.
ALCOA+ requires that measurement data is Attributable, Legible, Contemporaneous, Original, Accurate – plus Complete, Consistent, Enduring and Available.
Yes, the revised Annex 1 requires all manufacturers to have a documented CCS covering the entire contamination risk.
More articles
What is air sampling and when is it needed?
An introduction to air sampling – what it involves, which situations require it, and what to expect from the process.
How to interpret an air sampling report
A guide to understanding your air sampling report – what the results mean, how they compare against reference values, and what actions may be required.
Cleanroom classification according to ISO 14644: a complete guide
ISO 14644 is the international standard for cleanroom classification. Read about cleanroom classes, how classification is performed and what requirements apply.
