Environmental Monitoring & Bioburden Control in Light of EU GMP Annex 1

Environmental monitoring (EM) and bioburden control are foundational to contamination control in pharmaceutical manufacturing. With the revision of EU GMP Annex 1, expectations for risk-based monitoring programs, trending, and continuous improvement have significantly increased.

In this on-demand webinar, Johannes Oberdörfer shares practical, experience-driven guidance on how Annex 1 impacts environmental monitoring and bioburden control programs — and what QC microbiology and QA teams should be doing today to remain compliant and inspection-ready.

What You’ll Learn

In this session, you’ll gain practical insight into:

• What environmental monitoring and bioburden control are — and what they are not

• Key EU GMP Annex 1 changes affecting QC microbiology laboratories

• How environmental monitoring supports an effective contamination control strategy (CCS)

• Risk-based selection of sampling locations and monitoring frequencies

• Alert and action limits, trending, and periodic program review

• Limitations of traditional monitoring and the value of faster feedback

• Practical next steps for Annex 1 gap assessments and compliance planning

Why This Matters Now

EU GMP Annex 1 places increased emphasis on quality risk management, reduced human intervention, faster detection of contamination, and continuous improvement of monitoring programs. Regulatory expectations have shifted — and “waiting for guidance” is no longer an option.

This webinar helps translate Annex 1 language into practical, real-world considerations for environmental monitoring and bioburden control programs in GMP facilities.