Protect your patients. Strengthen your operations.
We help biopharma manufacturers and CDMOs strengthen sterility assurance, implement Annex 1 compliance, and eliminate contamination risks — where it matters most: in production.
Why Sterility Assurance and Annex 1 Compliance Are Business-Critical
- 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
We focus on practical solutions — not paperwork. Our services include:
- Development or remediation of your Contamination Control Strategy (CCS)
- Risk-based Contamination Control Risk Assessment (CCRA) to guide strategy and actions
- Optimization of your Environmental Monitoring (EM) program
- Aseptic behaviour training, assessment, and Quality Oversight
- Gap assessments and Annex 1 compliance roadmaps
- Design and improvement of your Sterility Assurance 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
- Experience across biologics, vaccines, and biosimilars
- Solutions designed for real-world production environments
- Onsite and remote support tailored to your plant operations
- Hands-on support during regulatory inspections (FDA, EMA, Swissmedic)
We simplify sterility assurance and Annex 1 compliance — without unnecessary complexity.