Eudralex Annex 1 Remediation

Compliance, performance, and quality — delivered with certified expertise

The evolution of Annex 1 of the Eudralex guide marks a major turning point for sterile drug manufacturers. This new version introduces stricter requirements regarding contamination control, airflow, environmental monitoring, and risk management.

At RealDev, we support manufacturers in ambitious, tailor-made remediation projects with a single goal: helping you achieve and maintain a high level of compliance without compromising operational performance.

Why Remediation Can No Longer Wait

The update to Annex 1 requires a comprehensive reassessment of your critical processes. Health authorities now expect concrete evidence of risk control at every level:

Demonstration of a robust and well-documented state of control
Control over the design of sterile areas (cleanrooms, LAF, RABS, isolators)
Implementation of coherent Contamination Control Strategies (CCS)
Strengthening of environmental monitoring plans
Increased rigor on data and documentation (ALCOA+)

❗ Inspections are more frequent, more demanding, and less tolerant of improvisation.

Don’t wait any longer !

RealDev, a trusted partner

ISO 9001 certified quality

Our management system is ISO 9001 certified, ensuring consistent rigor, complete traceability, and a high level of quality in every project. Compliance is ingrained in our DNA.

Recognized industry expertise

Our teams are made up of field experts from the pharmaceutical sector: process engineers, quality assurance managers, CSV specialists, validation experts… Complete mastery of GMP environments, Annex 1, and regulatory expectations.

An integrated and operational approach

Thanks to our Totally Integrated Services methodology, we support you end-to-end: analysis, strategy, execution, documentation, training. One single partner for efficient remediation without wasting time.

A culture of results and performance

We don’t just deliver documents: we prepare you for inspections with finalized, compliant, and ready-to-use deliverables. Our goal: to help you improve both compliance and performance.

Our project approach: rigor, expertise, results

Every remediation project at RealDev follows a proven approach, tailored to your challenges, resources, and regulatory deadlines:

Gap analysis and strategic diagnosis

Mapping gaps with Annex 1
Prioritization of critical actions
Budgetary and regulatory planning

Remediation design

Development of a comprehensive and prioritized CCS (Contamination Control Strategy) plan.
Definition of CAPA, documentary, and technical actions.

Operational implementation

Writing procedures and validating processes
Redesign or improvement of the monitoring system (EMS)
Targeted team training
Commissioning and inspection support

Follow-up and sustainability

Compliance management
Periodic quality reporting and reviews
Knowledge retention and transfer

Support on the critical points of Annex 1

Our projects cover all the enhanced requirements of the new Annex 1:

Contamination Control Strategy (CCS)
Flow mapping and risk analysis (QRM)
Qualification of classified areas and critical equipment
Validation of aseptic processes (media fill, simulated interventions)
Environmental monitoring (EMS, dual probes, alarms, reviews)
Document management and Data Integrity (ALCOA+, audit trails)
Training and empowerment of personnel

Concrete example: the Dual Probe project

As part of an Annex 1 remediation project, RealDev deployed an environmental detection solution using dual probes on a critical aseptic line.

Objective: to enhance the reliability of particle measurements in ISO 5 areas while meeting the redundancy, traceability, and real-time requirements imposed by the Annex.

This project included: