Sterility Assurance Consulting & Annex 1 Compliance for Biopharma

Protect your patients. Strengthen your operations

We deliver sterility assurance consulting that helps biopharma manufacturers and CDMOs strengthen contamination control and achieve Annex 1 compliance. Sterile operations demand more than SOPs — they require a robust Contamination Control Strategy (CCS), risk-based oversight, and practical execution on the shopfloor.

EU GMP Annex 1 compliance is now a non-negotiable requirement for sterile biologics and advanced therapy manufacturers worldwide. Weak contamination control can halt batch release, trigger regulatory findings, and damage supply reliability. Sterility risks are not only regulatory — they are strategic business risks that affect patients, timelines, and investor confidence.

With GMP Bridge, sterility assurance becomes a strength: structured, risk-based, and inspection-ready.

Why Sterility Assurance and Annex 1 Compliance Are Business-Critical

EU GMP Annex 1 compliance is now a non-negotiable requirement for sterile biologics manufacturers operating in the EU and globally.

Weak contamination control can stop batch release, trigger regulatory findings, and jeopardize your supply chain.

A solid Contamination Control Strategy (CCS) — supported by risk-based execution — is essential for inspections and daily operations.

Sterility risks are not just a regulatory issue; they are a business risk.

What We Deliver

Development or remediation of your Contamination Control Strategy (CCS)

Risk-based Contamination Control Risk Assessment (CCRA) to guide strategy and actions

Aseptic behaviour training, assessment, and Quality Oversight

Gap assessments and Annex 1 compliance roadmaps

Design and improvement of your Sterility Assurance Program

Optimization of your Environmental Monitoring (EM) program

Support in resolving contamination events and deviations

Hands-on preparation for inspections and audits focused on sterility assurance

Why Choose GMP Bridge

Senior consultants specialized in aseptic manufacturing and sterility assurance

Every sterility assurance project at GMP Bridge is led by senior consultants with decades of hands-on experience in aseptic manufacturing. Our experts have successfully implemented contamination control strategies and sterility assurance programs in high-throughput biologics and ATMP facilities, consistently reducing contamination events and deviation rates.

Experience across biologics, vaccines, and biosimilars

We have delivered proven results for clients manufacturing monoclonal antibodies, viral vectors, vaccines, and biosimilars. Our team has helped sites achieve Annex 1 compliance, pass critical FDA and EMA inspections, and resolve complex sterility challenges unique to each product type.

Solutions designed for real-world production environments

Our recommendations are always practical and tailored to your facility’s realities. For example, we have redesigned environmental monitoring programs and aseptic operator training to fit actual production schedules—leading to measurable improvements in audit outcomes and day-to-day performance.

Onsite and remote support tailored to your plant operations

GMP Bridge offers both onsite and remote support, adapting to your operational needs and timelines. We have supported clients during urgent contamination events with rapid onsite interventions, as well as provided ongoing remote guidance for continuous improvement and compliance.

Hands-on support during regulatory inspections (FDA, EMA, Swissmedic)

Our consultants have guided teams through high-stakes inspections, including FDA, EMA, and Swissmedic. We provide real-time support—preparing documentation, coaching staff, and helping respond to inspector questions. Our clients have achieved successful inspection outcomes, even after previous findings.

Is your sterility assurance strategy protecting your supply?

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