GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software

Challenge

The client needed to effectively close several open CAPAs stemming from internal audits and regulatory requirements, within a highly demanding GMP environment.

The main challenge was implementing robust and sustainable solutions across Quality Assurance, Qualification & Validation, and Software, within tight deadlines, while minimizing regulatory risk and meeting the expectations of health authorities.

Approach

QbD Group provided end-to-end GMP support, working closely with the client’s teams across QA, Qualification & Validation, and Software.

The approach included:

• Developing master documents and SOPs from scratch, and improving existing SOPs

• Optimizing key processes and addressing audit-related deviations using risk-based tools

• Ensuring continuous follow-up until final CAPA closure, guaranteeing long-term sustainability

This practical, collaborative approach ensured full compliance and measurable improvements in the client’s GMP systems.

Result

The project achieved 100% closure of planned CAPAs, with all corrective and preventive actions meeting GMP requirements and regulatory expectations.

As a result, the client significantly reduced regulatory risk, strengthened quality, validation, and software systems, and improved audit and inspection readiness.

QbD Group’s support was instrumental in effectively closing our CAPAs and strengthening our GMP systems. Their hands-on, risk-based approach enabled us to implement sustainable solutions and significantly improve our regulatory readiness.

GMP Quality Auditor at Biotech CDMO