EU GMP Annex 1 (2022)

Contamination control
from design through governance.
Inspection ready. Always.

Contamination Control by Design™ (CCbD™) embeds contamination control into your operation — protecting your product, your patients, and your business. It is not a document generator. It is a fully operational compliance programme, delivering a structured CCS, 30+ GMP procedures, and a governance system that works from day one through every inspection cycle.

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Annex 1 (2022) aligned

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EMA expectation aligned

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Proprietary risk library

CCbD™ Platform

sterile Annex 1 (2022) Draft v0.3

Project

Dublin Fill Suite CCS 2026

sterile

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Dashboard

Workflow

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01a Risk Profile

01b Process FMEA

02 Ingress Points

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03 Mitigation

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04 Qualification

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05 Monitoring

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06 Governance

Project Dashboard

CCS Readiness

38%

Risks

21 lib + 3 site

HIGH/CRIT

Action required

Open Items

Blocking CCS

STEP 01a

Risk Profiling

✓ QA approved

STEP 01b

Process FMEA

⚠ Gate blocked

STEP 02

Ingress Points

⚡ In progress

STEP 03

Mitigation

○ Not started

STEP 04

Qualification

○ Not started

STEP 05

Monitoring

○ Not started

STEP 06

Governance — Events · EM · CAPAs · Change Control · Annual Review

○ Not started

Open Items — Blocking CCS Completion 8 open

PS-008 Aseptic Filling — CRITICAL NPMR 100 — no control assigned

CCbD-001b §7.2 → CCbD-003 §4.3 · RABS/Isolator spec required

Pressure cascade failure — no design action assigned

CCbD-001 R-007 · HIGH (RPN 30) · Engineering control required

3 ingress points not linked to risks or FMEA steps

CCbD-002 IP-015, IP-016, IP-017 · Step 2 gate condition

The Contamination Control Problem

Most sites are managing their CCS in Word and Excel.

Annex 1 (2022) mandates a documented CCS for every sterile site. But the obligation does not stop there. EU GMP Part I requires every pharmaceutical manufacturer — sterile or not — to actively identify, assess, and control contamination risks. Most sites have no structured programme to show an inspector.

This applies to every manufacturing modality — sterile, bioburden controlled, non-sterile, biologic, and ATMP.

Problem 01 — Traceability

No link between risks, controls, and Annex 1 clauses

Risk registers in Word have no automatic connection to the engineering controls or monitoring requirements they should drive. Inspectors ask for the link. There isn't one.

Problem 02 — Completeness

CCS documents built from scratch miss systematic risks

Without a reference library, teams identify risks they know about. Risks they haven't considered never appear. A gap in the CCS is a finding waiting to happen.

Problem 03 — Scalability

A new site means starting over from a blank document

Every CCS is rebuilt from scratch. No institutional starting point, no consistency across sites, no way to demonstrate a systematic approach to contamination control across a portfolio.

The Cost of Getting This Wrong

A contamination finding is not a paperwork problem.

EMA, FDA, and HPRA inspectors are finding CCS gaps on every inspection cycle. The consequences are not administrative — they are operational, financial, and reputational.

$10M+

Cost of a Drug Recall

Average pharmaceutical recall costs $10M–$100M in direct costs. Major contamination events have reached $600M — before litigation, reputational harm, or lost revenue.

~15%

Warning Letter Remediation

GMP warning letter remediation costs ~15% of annual revenue in direct costs alone — before import alert revenue loss and supply chain disruption.

24 mo

Average Remediation Time

GMP remediation programmes are measured in months. From inspection observation to confirmed return to compliance takes up to 24 months on average.

Cause of Pharma Recalls

Sterility failures and inadequate cGMP compliance are the top two causes of pharma recalls — both directly addressed by a structured CCS programme.

CCbD™ vs. The Traditional Approach

Why the way it has always been done is no longer good enough.

80% of pharmaceutical sites take 9 months or more to build a contamination control programme from scratch — at a cost of €100k or more in consultant time, with no guarantee of inspection readiness at the end.

Traditional Approach

Multiple consultants · Word · Excel

CCbD™ Platform

Structured · Gated · Evidence-based

9+ months average build time

Starting from a blank document every time, with no structured starting point or reference library

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Six weeks — guaranteed

190+ pre-configured risks loaded instantly. Structured workflow from day one. If not inspection-ready at six weeks, we continue at no additional cost

€100k+ in consultant time

Multiple external consultants, internal SME time, document management overhead, and no reusable output for the next site

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€28.5k — fully inclusive

Platform access, expert delivery, 30+ GMP procedures, risk library, all eight documents, and a live project your team maintains going forward

No traceability between risks and controls

Word documents have no structural link between a contamination risk, its assigned engineering control, and its monitoring requirement

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Full traceability — automatic

Every risk links to its Annex 1 clause, engineering control, qualification activity, and monitoring requirement. Inspector-navigable in seconds

Rebuilt from scratch for every site

No institutional knowledge carried forward. CDMOs and multi-site operators repeat the same expensive process each time

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Reusable across every site

The methodology, risk library, and platform carry forward. Each new site builds on the last. CDMOs demonstrate portfolio-wide consistency

No ongoing governance or lifecycle management

The document is filed. No mechanism to track contamination events, EM excursions, CAPAs, or annual review. The CCS becomes stale within 12 months

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Built-in governance through Step 06

Contamination event register, EM excursion tracker, CAPA log, change control impact assessment, and annual CCS review — all live, all linked

The Contamination Control by Design™ Methodology

Six steps. Gated progression. One inspection-ready CCS.

The CCbD™ Platform enforces the six-step lifecycle framework — each stage gates the next. A step cannot be completed without resolving identified gaps. No document is generated until the data is complete.

Step 01a · CCbD-001

Contamination Risk Profile

Facility-level risk assessment using the Pharmalliance-curated modality risk library. 190+ pre-configured risks — Annex 1 mapped, severity-calibrated, GMP chapter cross-referenced.

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Generates CCbD-001 Risk Profile Report

Step 01b · CCbD-001b

Process Microbial FMEA

Proprietary NPMR four-parameter scoring engine (L × I × P × IC). Kill step map. Automatic escalation override. The only process-level microbial FMEA integrated with facility risk data.

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Generates CCbD-001b Process FMEA

Step 02 · CCbD-002

Contamination Pathway Mapping

Every ingress point identified, categorised, and linked to risk register entries and FMEA steps. Gate condition: all ingress points must be linked before Step 3 can proceed.

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Generates CCbD-002 Pathway Map & Register

Step 03 · CCbD-003

Engineering Design Controls

Five-category design control matrix — Facility, HVAC, Equipment, Utilities, Process. Every HIGH and CRITICAL risk must have an assigned engineering control before this step closes.

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Generates CCbD-003 Design Specification

Steps 04–05 · CCbD-004/005

Qualification & Monitoring

Qualification and verification plan with NPMR-driven monitoring requirements. EM programme automatically populated from risk and FMEA data. Bioburden hold points linked to batch records.

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Generates CCbD-004 and CCbD-005

Step 06 · CCbD-006

Governance & Lifecycle Review

Contamination event register, EM excursion tracker, CAPA register, change control impact assessment, and annual CCS review certification — all linked back to the risk register.

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Generates CCbD-006 Governance Report

Manufacturing Modalities

Select your manufacturing context.
The Contamination Control by Design™ platform calibrates everything else.

A single modality selection drives your risk library, FMEA step library, regulatory compliance headers, environmental monitoring limits, and Annex 1 cross-reference scope — automatically.

sterile

Sterile Manufacturing

EU GMP Annex 1 (2022) · ISO 14644 · ICH Q9(R1)

Covers aseptic processing, terminal sterilisation, biologics, ATMPs, and ophthalmic products. Grade A/B/C/D risk library. Full Annex 1 compliance matrix. RABS and Isolator FMEA steps. Sterilising filtration kill step chain.

⬚ 130+ pre-configured contamination risks

bioburden_controlled

Bioburden Controlled

EU GMP Annex 1 §8.17–8.26 · §8.123–8.132 · Ph. Eur. 5.1.4

Dual context — kill step prerequisite (Context A) and specification release against Ph. Eur. 5.1.4 (Context B). Endotoxin, Gram-negative biofilm, hold time validation, and specified organism risks included.

⬚ 60 pre-configured contamination risks

non_sterile_gmp

Non-Sterile GMP

EU GMP Part I · ICH Q7 · EMA Cross-Contamination Guideline

OSD, topicals, oral liquids, and non-sterile APIs. Cross-contamination, cleaning validation, HVAC containment, and equipment train segregation risk library.

⬚ Pre-configured contamination risk library

Deliverable Documents

Eight CCS documents. Generated on demand. Inspector-ready from day one.

Every deliverable is generated server-side from structured platform data. No copy-paste, no formatting, no gaps. Client-branded, unbranded, or CCbD™-styled — your choice at generation time.

CCbD-001

Contamination Risk Profile Report

Risk register, distribution summary, HIGH-risk design action table, full Annex 1 cross-reference.

CCbD-001b

Process Microbial Control FMEA

NPMR scoring table, kill step map, sterilisation assurance chain, bioburden monitoring requirements.

CCbD-002

Contamination Pathway Map & Register

Ingress point register, pathway register, map references, and contamination route conclusions.

CCbD-003

Engineering Design Specification

Design control matrix across five categories: Facility, HVAC, Equipment, Utilities, Process.

CCbD-004

Qualification & Verification Plan

Verification matrix, qualification status summary, airflow studies, gowning qualification, EM baseline.

CCbD-005

Operational Monitoring Plan

EM programme tables, NPMR-linked monitoring point register, response matrix, trending schedule.

CCbD-006

Governance & Lifecycle Review

Event register, EM excursion tracker, CAPA register, change control log, annual CCS review certification.

Any step ≥ 80% complete

Partial CCS — Work in Progress

Generate a draft CCS at any stage — including a compliance gap register showing exactly what remains outstanding before final approval.

CCS — All Steps Complete

Contamination Control Strategy

Fully formatted, client-branded, Annex 1-aligned CCS document. All 17 sections. Process FMEA summary. Mitigation matrix. Qualification summary. Annex 1 cross-reference matrix. Approval page. Ready for QA Director signature and regulatory submission.

Inspection
Ready

Free Industry Resource

The CCbD™ Standard

The open industry reference document for Contamination Control by Design™ — published by Pharmalliance Consulting Ltd and freely available to all pharmaceutical manufacturers. The Standard defines the six-phase CCbD™ lifecycle framework and its application across all three manufacturing modalities.

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EU GMP Annex 1 (2022) aligned

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All three modalities covered

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Free — no licence required

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CCbD™ Standard

CCbD-STD-001 · Industry Release · Pharmalliance Consulting Ltd

EU GMP Annex 1 (2022) Six-phase lifecycle Sterile · Bioburden · Non-Sterile NPMR methodology ICH Q9(R1)

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Built on a Proven Programme

The Pharmalliance CCS methodology has been delivering inspection-ready contamination control programmes for sterile manufacturers since before CCbD™ was built. The platform automates, structures, and scales what our consultants have always done manually — faster, more consistently, and at lower cost.

The whole project was very professionally handled. The experience and knowledge of the Pharmalliance team was outstanding and helped much overcoming misunderstandings and knowledge gaps on our side. Deliverables were provided in time and Pharmalliance kept us on track.

Senior Global Director of QA

Global Aseptic CDMO · CCS in 6 Weeks Engagement · Pharmalliance Consulting Ltd

CCbD™ is the structured platform built on this same methodology — delivering the same six-week outcome with greater consistency, full regulatory traceability, and a governance system your team maintains indefinitely.

Access & Pricing

Guided Execution. Then stay audit-ready — always.

Pharmalliance experts build your contamination control programme with you — the right way, the first time. Then your team maintains it with platform access and ongoing support.

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The CCbD™ Execution Guarantee

If your contamination control programme is not inspection-ready at six weeks, we continue at no additional cost until it is.

Start Here

Guided Execution

€28.5k / per site engagement

Pharmalliance expert-led — fully operational in six weeks

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Full CCbD™ Platform access for one site
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Expert-led delivery across all six CCbD™ steps
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190+ risk library pre-loaded and calibrated to your facility
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Process FMEA facilitation with your Microbiology SME
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30+ audit-ready GMP procedures delivered
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All eight CCbD™ deliverable documents generated
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Complete, QA-approved CCS at completion
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Inspection readiness review included

Start the Conversation →

Stay Audit-Ready 365

Annual Subscription

€8.5k / site / year

Platform access, governance support, and ongoing regulatory alignment

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Full CCbD™ Platform access — all six steps
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Unlimited CCS document generation
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Step 06 Governance — event register, EM tracker, CAPA log
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Pharmalliance-led annual CCS review
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12-month rolling inspection readiness gap analysis
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Change control impact assessment against your CCS
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Risk library and regulatory intelligence updates
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Multi-site portfolio pricing available

Contact for Subscription →

CCbD™ Training Programme

The training your team needs to maintain compliance — and own it.

A CCbD™ deployment is a living programme, not a one-time project. Three structured training tiers — all fully self-paced and online — ensure your QA team understands the framework, can operate the platform, and can sustain a compliant CCS through inspections, changes, and annual reviews.

All three tiers are fully aligned with EMA inspection expectations for contamination control strategy competency and lifecycle governance.

Explore CCbD™ Training →

CCbD™ Foundation

Fully self-paced online. 12 short video modules, ~5 min each (~60 min total). 20-question knowledge check, 75% pass. No prerequisites. Certificate issued automatically on passing. For anyone who needs to understand the CCbD™ framework — regardless of role on the platform.

CCbD™ Practitioner

Fully self-paced online. 12 platform walkthrough video modules, ~15 min each (~3 hrs total). Screen recordings of the live CCbD™ platform. 15-question assessment, 75% pass. For QA, Engineering, and Microbiology contributors operating the platform day-to-day.

CCbD™ Architect

4 self-paced video modules (~2 hrs) covering programme ownership, governance leadership, CCS architecture, and complex scenario strategy. Followed by a complete CCbD™ programme build on the live platform (~4–6 hrs), reviewed by Pharmalliance against the Architect competency framework. For CCS Owners, QA Directors, and senior leads accountable for the programme.

Contamination control from design through governance. Inspection ready. Always.

Contamination control
from design through governance.
Inspection ready. Always.