Integrated Contamination Risk Governance for Barrier Technology Projects.
We bridge Engineering and Quality to deliver barrier technology projects that perform technically and stand up to regulatory scrutiny.
5 Outstanding Benefits of our Barrier Technology Program
Dramatic reduction in Sterility Failure Risks
Regulatory Inspection readiness from Day One
Financial Protection Against High-Cost Contamination Events
Optimized Operational Efficiency & Lower Deviation Rates
Future-Proofed Contamination Control Strategy
Who This is Program For?
Our Barrier Technology Program can help if this is you:
The Problem
Pharmaceutical companies investing in barrier technology to meet EU Annex 1 requiring assured integration between engineering design and sterility assurance.
The Goals
Delivering barrier technology solutions fully aligned with EU GMP Annex 1 through engineered integration of design and sterility assurance.
The Company
Sterile drug manufacturers and advanced therapy CDMOs undertaking critical barrier technology upgrades requiring engineered sterility assurance.
What You Get – Day 1 Access
Everything you need to specify, purchase, install and qualify your Barrier Technology System:
Project Plan
Complete, structured project plan to deliver with confidence. Built to FDA / EMA expectations. Saves time, facilitates internal alignment and puts you in control from Day 1.
Corporate Quality Plan
Fully developed compliance roadmap linked to audit ready cGMP Quality Remediation plan. Structured for executive review and ready for submission to regulators.
Risk Assessment Toolkit
Rapid tools to identify, prioritise and map cGMP, CCS and Annex 1 risks. Includes facility flow maps, risk matrices, and cleanroom failure libraries to get instant visibility and action alignment.
EMA-Compliant Quality Updates
URS, TS, DQ, IQ, OQ, PQ, SOPs, protocols, validation templates, and QMS links. All pre-formatted, EU Annex 1 aligned. Removes ambiguity and ensures your system suitability.
Annex 1 Compliance
Expert Annex 1 and Microbial Control FMEA gap analysis performed on your facility and process, identifying gaps, ensuring compliance with regulatory expectations.
Expert Support
Specialist Pharmalliance support throughout the project. Includes all the support you need to identify gaps, create documentation and project manage the effort.
Execution Plan
Project Planning
You Get:
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Collaboration to define of "What success looks like"
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Agreement of project Scope, Timeline and Schedule
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Detailed project plan with Charter, Plan and RACI matrix
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Stakeholder Engagement
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Data gathering and documentation reviews
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Project governance definition
Project Documentation
You Get:
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Executive-Level cGMP & Annex 1 Gap Assessment
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Complete Barrier Technology Specification Package to confidently specify, tender, and procure barrier system
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End-to-End Validation Framework for IOPQ
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Integrated Contamination Control Strategy (CCS)
Detailed Gap Analysis
You Get:
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cGMP, EU Annex 1 and Microbial Control FMEA of end to end process
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Visual dashboards to easily understand risk portfolio
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Facility Risk Map (people, material, product, waste)
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GxP Process Criticality Matrix
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Environmental Monitoring and Utilities Risk Analysis
Inspection Readiness Pack
You Get:
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Annex 1 Traceability Built-In
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Defensible Aseptic Strategy
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Demonstrates full integration between Engineering and QA
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Structured APS and environmental monitoring rationale
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Organized IQ/OQ/PQ evidence with clear justification of critical parameters.
In Person Site Visit
You Get:
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Expert on site Facilities, Utilities, Process, Cleaning, Sterilization audit
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Documentation review
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Finalization of risk assessments
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Site presentation mapping current cGMP Annex 1 level to future level
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cGMP and CCS training session
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Definition of next steps
Training & Behaviour Change
You Get:
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CPD-Certified Training: GMP Fundamentals, Contamination Control Excellence Program
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35 Microlearning Modules (24/7, online and SCORM-ready)
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Training Matrix + Role-Based Modules
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Operator Training Assessments + Audit-Ready Records
Testimonials
Senior Director, Global CDMO
"The experience and knowledge of the Pharmalliance team was outstanding and helped much overcoming misunderstandings and knowledge gaps on our side."
QP + Quality Head, Vaccines
"Pharmalliance helped with a CCS development project where there was a great deal of pressure to go very quickly. They were very effective strategizing what needs to be done."
QA Manager, Sterile OTC
“We faced numerous technical challenges, but their service delivered brilliant solutions. Their hands-on approach meant we felt supported throughout the project. ”
Included Bonuses
1
Internal Audit Toolkit
We provide all the templates that you need to identify your cGMP / Annex 1, and Microbial Control risks. These risks are assigned a Risk Priority Number (RPN) and linked to CAPA's.
2
CPD Training Modules
Our CPD Certified cGMP Fundamental and Contamination Control Program elevate your sites knowledge and compliance level quickly. These training programs are available 24/7.
3
Full Site Access
GMP Knowledge should not be confined to a select few individuals. For lasting change the whole site gets access to our CPD Certified material for 1 year post purchase.
Some of our happy clients
