In today’s pharmaceutical landscape, regulatory inspections are more rigorous than ever, with agencies like the FDA and EMA focusing sharply on contamination control strategies.
Non-compliance can lead to warning letters, costly recalls, and damaged reputations.
The problem?
Most companies struggle to build an integrated, audit-ready contamination control program that meets evolving expectations.
At Pharmalliance Consulting Ltd., we specialize in solving this problem, fast. Our proven framework guarantees that your organization can achieve a fully audit-ready Contamination Control Program (CCP) in 90 days or less.
Whether you’re preparing for an inspection, recovering from a compliance issue, or proactively enhancing your GMP compliance levels, our tailored approach ensures rapid, measurable results.
The Compliance Challenge
Pharmaceutical companies face multiple hurdles in establishing robust contamination control:
Fragmented Systems: Disconnected processes lead to inconsistent compliance practices.
Regulatory Changes: Keeping up with EU Annex 1 revisions, FDA guidance, and global GMP expectations is overwhelming.
Documentation Gaps: Many companies lack the comprehensive SOPs, risk assessments, and validation protocols inspectors expect.
Pharmalliance bridges these gaps, providing a streamlined, risk-based approach that transforms your contamination control program into an inspection-ready program, quickly and effectively.
The Pharmalliance Solution: A Holistic Approach to Compliance
Pharmalliance Consulting Ltd. doesn’t just offer advice, we deliver transformative results through our CPD Certified Contamination Control Excellence Program (CCEP), designed to Educate, Execute, and Elevate your compliance framework.
Here’s how we achieve rapid improvements:
Step 1: Annex 1 Evaluation Tool
We begin with our Free Annex 1 Evaluation Tool, designed to:
Benchmark your current state against EU Annex 1 (2022) requirements.
Identify compliance gaps in contamination control, environmental monitoring, personnel practices, and more.
This step ensures we focus efforts where they matter most, saving time while maximizing compliance impact.
Step 2: Contamination Control Excellence Program (CCEP)
Our Contamination Control Excellence Program (CCEP) is the engine that drives rapid transformation.
Structured into three dynamic phases:
Educate – Comprehensive Training:
Tailored training modules covering contamination risks, EU Annex 1 expectations, environmental controls, and more.
Our CPD Certified training is available 24/7 on web and mobile.
Training occurs in parallel to the Execute package to ensure each team member has the necessary skills and knowledge to operate
Execute – Full Implementation Package:
We don’t just provide recommendations, we deliver everything required to pass an inspection with confidence:
Pre-built documentation packages: Full package of 35 purpose built Plans, Programs, SOPs and templates, all GMP-compliant and ready to deploy.
Custom risk assessments following ICH Q9 principles, ensuring a science-based, regulatory-aligned approach. These include full Annex 1, microbial control FMEA, HACCP and HAZOP tools and templates.
Practical workshops to instill contamination control principles across all organizational levels.
Elevate – Continuous Improvement:
Optional integration with our ISO 27001-compliant platform for real-time compliance tracking across multiple sites.
Step 3: Tailored Training and Support
We provide additional tailored training and support (on-site or remote) if you require additional support to implement controls, address identified gaps, and embed best practices.
Why Pharmalliance? Because Compliance Can’t Wait.
At Pharmalliance Consulting Ltd., we’re not just consultants we are your partner for contamination control and GMP compliance.
Our team brings decades of hands-on experience, regulatory insight, and innovative tools that no other consultancy offers, including:
✅ Audit-Ready in 90 Days or Less: No fluff, just focused, results-driven actions.
✅ End-to-End Support: From initial gap assessment to final audit preparation.
✅ Expert-Led: Our consultants bring decades of hands-on GMP and regulatory experience.
✅ Ready-Made Templates & Tools: Save months of effort with our pre-populated documentation.
✅ Regulatory Alignment: We stay ahead of evolving FDA, EMA, and PIC/S guidelines.
Conclusion
Achieving and sustaining cGMP compliance doesn’t have to be a complex, resource draining process. With Pharmalliance Consulting Ltd., you gain access to a comprehensive suite of tools, expert-led programs, and cutting-edge technology designed to deliver measurable compliance improvements within just 90 days.
Our approach isn’t about quick fixes, it’s about embedding a culture of contamination control and operational excellence that ensures long-term regulatory readiness.
From the Annex 1 Evaluation Tool to our Contamination Control Excellence Program (CCEP) and the transformative power of our ISO 27001-compliant real-time compliance platform, we provide everything you need to not just meet compliance standards, but exceed them.
To stay ahead of evolving regulations, minimize risks, and enhance your contamination control practices, join our CPD Accredited Contamination Control Excellence Program.
More information and sign up here: https://www.pharmalliance.ie/ccs-excellence
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