---
title: "Annex 1 Compliance Diagnostic | QbD Group"
description: "A practical diagnostic across the seven areas most frequently flagged in inspections. 20 questions, 7 sections, instant results."
url: https://qbdgroup.com/en/annex-1-diagnostic
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Annex 1 Compliance Diagnostic | QbD Group\", https://qbdgroup.com/en/annex-1-diagnostic"
---

EU GMP Annex 1

# Annex 1 Compliance Diagnostic

A practical diagnostic across the seven areas most frequently flagged in inspections.

20 questions · 7 sections · Instant results

**Important:** This diagnostic provides a non-binding, informational assessment only. It does not constitute regulatory advice.

GDPR Compliant

No Spam Guarantee

## The Seven Areas Covered

Each section maps to a source of deficiency that regulators and FDA warning letters consistently identify.

### Contamination Control Strategy (CCS)

Is contamination prevention governed as a system, or managed as a collection of procedures?

### Cleanrooms, Isolators & Barrier Technologies

Does your physical environment and barrier strategy hold up under dynamic, operational conditions?

### Aseptic Concept & Barrier Technology Justification

Can you defend why your aseptic design choices effectively control contamination risk?

### Personnel, Gowning & Aseptic Behaviour

Is aseptic behavior consistently demonstrated, or assumed?

### Cleaning & Disinfection

Are your cleaning and disinfection practices designed, validated and governed as part of the CCS?

### Utilities & Pharmaceutical Water Systems

Are your utility systems designed, monitored and maintained to the standard Annex 1 now requires?

### Process Control, Validation & Data Integrity

Are your processes in a demonstrated state of control, and can you prove it?

## How to Use This Diagnostic

Annex 1 remediation is rarely a single project. For most sites, full compliance requires changes across multiple systems, facility, utilities, processes, personnel and documentation, each with its own timeline, dependencies and level of urgency. Without a clear picture of where the gaps are and how they relate to inspection risk, it is difficult to sequence that work effectively.

This diagnostic is designed to give you that picture. Across seven areas that regulators and FDA warning letters consistently identify as the most common sources of deficiency, it helps you assess where your site's contamination control is robust, where gaps exist, and where the exposure to a critical inspection finding is highest.

The goal is not to produce a compliance score, it is to give you a structured basis for deciding where to focus remediation effort first.

For each question, select the option that most honestly reflects where your site stands today, not where you plan to be.

A

### In place and documented

Evidence is available.

B

### Partially in place

Gaps are known but not fully resolved.

C

### Not yet addressed

Potential inspection risk.

## Ready to Check Your Site?

Answer 20 questions across seven sections to see where your contamination control is robust and where inspection exposure is highest.

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Source: https://qbdgroup.com/en/annex-1-diagnostic — © QbD Group. Quote freely with attribution and a link back.