---
title: "Ensuring pharmaceutical production quality: cleaning validation for government agency"
description: "Discover how QbD Group helped a client tackle dual validation challenges for their production lines, ensuring GMP compliance and AEMPS approval."
url: https://qbdgroup.com/en/case-studies/ensuring-pharmaceutical-production-quality-cleaning-validation-for-government-agency
type: "Case study"
language: en
published: 2024-05-31
publisher: "QbD Group"
citation: "QbD Group, \"Ensuring pharmaceutical production quality: cleaning validation for government agency\", https://qbdgroup.com/en/case-studies/ensuring-pharmaceutical-production-quality-cleaning-validation-for-government-agency"
---
# Ensuring pharmaceutical production quality: cleaning validation for government agency
> Discover how QbD Group helped a client tackle dual validation challenges for their production lines, ensuring GMP compliance and AEMPS approval.

## Streamlining cleaning validation

In 2022, a longstanding client who had previously engaged our services for Risk-Based Environmental Monitoring (RRAA) sought our expertise for their **Cleaning Validation initiative across their production lines handling Oral Solid Forms (OSF), Semi-Solids, and Sterile products.** This project demanded a holistic approach, encompassing everything from toxicological evaluations, including Permitted Daily Exposure (PDE) assessments, to preparation of essential quality documentation.

This project represents a collaborative effort, with both our toxicology and quality assurance departments actively engaged.

## Challenge

### GMP compliance: meeting dual validation challenges

The challenge was twofold: first, to **conduct** **comprehensive cleaning validations** essential for product registration under GMP guidelines, and second, to **ensure** **strict compliance** with these validations for impending agency inspections.

## Approach

### Seamless service delivery approach

Our approach is founded on delivering top-tier service, professionalism, expertise, and profitability.

QbD Group ensures seamless coordination across all departments for efficient service delivery. A **multidisciplinary project management team** oversees timelines, milestones, and client communication, ensuring agile and transparent collaboration throughout the project.

## Result

### Cleaning validation success

While the project remains ongoing, notable progress has already been made in the Cleaning Validation process. **Our client is now equipped with all required documentation**.

A positive inspection by the Spanish Medicines Agency (AEMPS) underscores our dedication to upholding quality and regulatory standards.
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Source: https://qbdgroup.com/en/case-studies/ensuring-pharmaceutical-production-quality-cleaning-validation-for-government-agency — © QbD Group. Quote freely with attribution and a link back.