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
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.
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.
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.
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.
Environmental Monitoring
Implementing advanced EM requirements with continuous viable and non‑viable monitoring, data‑driven alert and action limits, and systematic trending. Providing guidance on monitoring system selection and optimal placement strategies using established EM risk‑assessment methodologies
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.
Is Your Facility Annex 1 Ready?
The updated Annex 1 creates immediate demand for engineering expertise in CCS development, barrier technology implementation, and comprehensive gap analysis. Arnan's deep knowledge of both the regulatory requirements and the practical engineering solutions positions 10AR uniquely to guide this transition.