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I will create your eu annex 1 contamination control strategy and aseptic documentation
Pharma Expert, 15 Yrs in Deviation and QMS for Audit Ready CAPA Review
Welcome to PharmaAssurance — senior pharma quality consulting backed by 15+ years in sterile manufacturing.
Core Expertise:
• Deviation & CAPA Strategy: Review for audit-ready CAPAs.
• Aseptic Fillin...
About this Gig
Is your aseptic QMS ready for EU Annex 1:2022 & FDA? Don't risk a critical audit finding on your sterile manufacturing. At PharmaAssurance, our team is led by senior QA Compliance Leaders with 15+ years of global biopharma experience. We specialize in designing and auditing aseptic process documentation that stands up to the toughest regulatory scrutiny (FDA, EU, WHO, ICH).
Our Expertise: We translate the complex requirements of the new Annex 1 into clear, defensible, and operational Contamination Control Strategies (CCS).
Core Services:
- CCS Structure & Outline: Building the strategic framework for your entire CCS, ensuring all 16 elements of Annex 1 are covered.
- SOP Gap Analysis: Meticulous review of your existing aseptic SOPs (gowning, disinfection, and EM) against current global standards.
- Aseptic QMS Strategy: Guidance on data integrity, risk management, and the holistic integration of your sterile manufacturing quality system.
- Audit Readiness: Targeted feedback to prepare your aseptic documentation for a successful regulatory inspection.
Ready for compliant aseptic manufacturing? Please message us first to discuss your current documentation status.
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FAQ
What exactly is a Contamination Control Strategy (CCS)?
The CCS is the critical, holistic document required by EU Annex 1:2022. We ensure your CCS covers all twelve required elements, including risk assessment, facility design, and Quality Risk Management (QRM).
My team has many old SOPs. Do you only audit against Annex 1?
No. We provide global compliance assurance. We audit your documentation against EU Annex 1:2022, FDA Aseptic Processing Guidance, WHO GMPs, ISO and ICH principles for a fully defensible QMS.
What is your approach to Gowning and Environmental Monitoring (EM) procedures?
We ensure these procedures reflect the latest Annex 1 requirements for barrier technology and data integrity. Our focus is on making these procedures verifiable, risk-based, and audit-ready.
