On demandRegulatory Compliance
Annex 1 Contamination Control Strategy — 18 Months In
What we have learnt from the first wave of Annex 1 inspections: what a good CCS looks like on paper, what inspectors challenge in person, and how to close the gap.
Host & moderator
Dr. Anika Desai
Head of Quality Assurance · Novartis
Date
Wed 1 Jul 2026
Time
11:00 UTC
Duration
45 min
Price
Free
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Browse webcastsAbout this session
Eighteen months into the revised EU GMP Annex 1, a clearer picture has emerged of how inspectors interpret the contamination control strategy expectation. This on-demand session reviews the observation patterns from a set of anonymised inspections and translates them into a concrete CCS structure that stands up to challenge.
The session covers isolator vs RABS decision-making, environmental monitoring programme redesign, and how to demonstrate — not merely document — a controlled state.
Session agenda
11:00 – 11:10
The inspection landscape
Where inspectors are focusing, and how the CCS expectation has evolved since the guideline took effect.
11:10 – 11:30
Anatomy of a defensible CCS
Structure, risk linkage, and the evidence chain that connects controls to monitoring outcomes.
11:30 – 11:45
Common gaps and quick wins
The three CCS gaps we see most often, and the fastest paths to closure.
What you'll take away
1
Observation patterns from the first 18 months of Annex 1 inspections
2
A CCS structure that maps cleanly to inspector expectations
3
How to justify isolator vs RABS choices in your CCS narrative
4
Redesigning EM programmes so results demonstrate control, not merely presence
Your speakers
Host
Dr. Anika Desai
Head of Quality Assurance · Novartis
Panelist
Sofia Martel
Senior Pharmacovigilance Scientist · Sanofi
Good to know
Is a CCS mandatory for non-sterile sites?+
The Annex 1 CCS requirement applies to sterile manufacturing; the principles remain useful for non-sterile sites but are not enforced under Annex 1.
Do you provide a CCS template?+
Yes — attendees can download a starter CCS structure that mirrors the framework demonstrated in the session.
How often should the CCS be reviewed?+
At minimum annually and after any significant process, facility, or equipment change — this is covered in the closing section.
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