Contamination Control Strategy Struggles?
Get Your Audit Ready CCS in 6 Weeks, Guaranteed.
Your complete EMA compliant Contamination Control Program built, deployed and executed in just 6 weeks.
Instant access. Full support. No guesswork.
3 Outstanding Benefits of our Contamination Control Excellence Program
Contamination Control Program tailored to your site in 6 weeks.
All the document templates you need for an EMA compliant audit ready CCS.
Expert support through the program to rapidly increase compliance.
Who This is Program For?
Our 6-Week Contamination Control Excellence Program can help if this is you:
The Problem
Pharmaceutical companies with an upcoming audit and struggling to implement an audit ready Contamination Control Strategy (CCS).
The Person
Site Heads, Quality Directors or Sterility Assurance Leads that want to take a proactive approach to Contamination Control regulations.
The Timeline
Pharmaceutical companies with recent observations or an upcoming audit and needing day rapid CCS within a 6 week timeframe.
The Modality
This program takes a holistic approach across Sterile, Non-Sterile, ATMP and Cosmetic manufacturing, tailored to your specific site requirements.
The Bandwidth
Pharmaceutical companies committed to quality but lacking regulatory experience or bandwidth and needing compliant and audit-ready results fast.
What You Get – Day 1 Access
Everything you need to build an audit-ready Contamination Control Strategy:
Regulatory Response Pack
Complete, structured response letter with root cause tools and CAPA tracker. Built to HPRA expectations. Saves time, avoids escalation, and puts you in control from Day 1.
EMA-Compliant Quality Updates
​SOPs, policies, protocols, validation templates, and QMS links. All pre-formatted, EU Annex 1 aligned. Removes ambiguity and ensures your system can withstand regulatory scrutiny.
Expert Support
Direct access to Pharmalliance GMP specialists through the full process. Includes all the support you need to identify gaps, create documentation and project manage the effort.
Risk Assessment Toolkit
​Rapid tools to identify, prioritise and map Contamination Control risks. Includes facility flow maps, risk matrices, and cleanroom failure libraries to get instant visibility and action alignment.
Annex 1 Compliance
Expert Annex 1 and Microbial Control FMEA gap analysis performed on your facility and process, identifying gaps, prioritising remediation activities and ensuring compliance with regulatory expectations.
Audit-Ready Documentation
​Instant access to SOPs, dashboards, walkthrough decks, and inspection Q&A binders. Every tool formatted for inspection use — no guesswork, just results you can present confidently.
Corporate Quality Plan
Fully developed remediation roadmap linked to CAPAs, timelines, owners and QA sign-off. Structured for executive review and ready for submission to regulators within 7 days.
CPD-Certified Training Program
Ready-to-deploy GMP and Contamination Control for QA, QC, Engineering and Manufacturing. SCORM-compatible and audit-ready with assessments, training matrix, and certification for inspection evidence.
Bonus Compliance Tools
​Includes 30+ SOPs, FDA 483 examples, audit checklists, risk assessments, 100 licenses for CPD training, and CCS templates. Value of €50k — all included with your site license at no extra cost.
6-Week Execution Plan
HPRA Response Pack
You Get:
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HPRA Response Letter Template (regulatory language + CAPA structure)
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Root Cause Analysis Tools: 5-Why, Fishbone, Human Error
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CAPA Tracker (with risk ranking, owners & due dates)
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Executive Brief: “What This Means” deck for internal alignment
Annex 1 Compliance
You Get:
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Expert Annex 1 gap analysis
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Microbial Control FMEA performed on your process
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Gap identification, prioritisation and remediation activities
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Compliance ensured with regulatory expectations
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Remediation support for document updates and project execution.
Risk Identification / Gap Analysis
You Get:
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Facility Risk Map (people, product, air, waste)
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GxP Process Criticality Matrix
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cGMP and EU Annex 1 Gap Mapper
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Environmental Monitoring and Utilities Risk Tools
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FMEA Templates (pre-populated for cleanrooms and equipment)
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
Corporate Remediation Plan
You Get:
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Corporate-Level Remediation Strategy (HPRA audit-proof format)
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SOP Gap Identifier Tool (auto cross-check vs regs)
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Risk-Based Implementation Plan (linked to CAPAs) ready for FDA submission
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RACI Matrix for Quality, Engineering, Operations
Inspection Readiness Pack
You Get:
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Finalised Response Letter + Supporting Documents
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Inspection Walkthrough Deck (10-slide format)
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​HPRA Reference Binder (with model answers)
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SOP-to-Reg Clause Mapping Tool
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Mock Inspection Readiness Checklist
Testimonials
QA Lead, Sterile Operation
“Pharmalliance delivered exactly what we needed – fast, relevant, and high-quality Aseptic Fundamental training tailored to our sterile ophthalmic remediation project. "
Executive Project Lead, OSD
"Their team’s real-time oversight and deep compliance knowledge were critical in improving documentation (ALCOA) and reducing deviations and aligning us with EU GMP expectations."
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
Remediation 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
