— Regulatory
Annex 1 Compliance
The updated EU GMP Annex 1 is the most significant regulatory change in sterile manufacturing in decades. 10AR provides expert guidance in understanding, implementing, and demonstrating compliance with its demanding requirements.
Key Annex 1 Focus Areas
1
CCS — Contamination Control Strategy
Development of a comprehensive, documented contamination control strategy that covers the entire manufacturing process. This is the central pillar of the updated Annex 1 — a multi-layered approach to protecting the product from contamination.
2
Barrier Technologies
Annex 1 explicitly promotes the use of isolators for aseptic processing. Guidance on transition planning, technology selection, and implementation strategy for moving from open processing to barrier-based systems.
3
PUPSIT
Post-Use Post-Sterilization Integrity Testing of sterilizing grade filters. Understanding when PUPSIT is required, how to implement it without compromising sterility, and how to design processes around this requirement.
4
Smoke Studies
Airflow visualization studies under dynamic (operational) conditions — not just at rest. Design of study protocols, execution guidance, and interpretation of results for regulatory submissions.
5
Gap Analysis
Systematic assessment of your current facility, processes, and documentation against the updated Annex 1 requirements — producing a prioritized remediation roadmap with clear timelines and cost estimates.
6
Vendor selection based on technical, quality, and commercial criteria
Decision support focused on the best overall value and compliance fit
