Restoring manufacturing timelines through expert deviation management

Quality Assurance

Pharma

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A leading biotechnology company faced a growing backlog of deviations, causing delays in batch release. While internal teams focused on managing root causes and handling new deviations, they needed external QA expertise to remediate outstanding manufacturing-related deviations and restore production timelines.

QbD Group deployed a team of QA specialists to work on-site, collaborating closely with production teams to eliminate bottlenecks and ensure an uninterrupted batch release process.

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About the client

The client is a global biotechnology company specializing in plasma protein therapies and immunology solutions. Its manufacturing site is focused on the development and production of plasma-derived medicines for various therapeutic applications.

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Challenge

2

Approach

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Result

Challenge

Overcoming manufacturing deviations for timely batch release

The client faced a significant backlog of deviations, preventing timely batch release. Internal teams were occupied with root cause analysis and managing new deviations, leaving limited capacity to resolve outstanding manufacturing-related deviations.

To maintain compliance and meet production targets, the company needed a dedicated team of QA experts to step in and streamline the resolution process.

Discover our approach

Approach

Deploying a hands-on, collaborative approach

QbD Group implemented a structured, on-site QA strategy, ensuring fast and effective deviation handling. Our approach included:

• Deployment of 8 QA experts, working 80% on-site to resolve outstanding deviations.
• On-site presence to remediate manufacturing deviations efficiently.
• Collaboration with production teams to improve resolution timelines.
• Commitment to meeting deadlines, ensuring a steady and timely batch release

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Result

Accelerating compliance and production efficiency

Since the project’s launch, QbD Group’s intervention has enabled the team to work at full speed to eliminate the backlog and ensure uninterrupted batch release. By integrating external QA expertise, the client has significantly improved its manufacturing efficiency while maintaining compliance.

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Struggling with deviation backlogs and manufacturing delays?

Let our QA experts help you streamline deviation management, eliminate bottlenecks, and maintain compliance. Contact us today to explore how we can support your team in achieving efficient, uninterrupted batch release.