GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software
GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software
Biotech CDMO
Qualification & Validation, Quality Assurance
Pharma & Biotech
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QbD Group supported a biotech CDMO in strengthening its GMP compliance by successfully closing all planned CAPAs across Quality Assurance, Qualification & Validation,and Software. This hands-on, risk-based support ensured sustainable improvements in processes, documentation, and regulatory readiness, helping the client reduce risk and enhance overall operational quality.
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Challenge
2
Approach
3
Result
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:
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Developing master documents and SOPs from scratch, and improving existing SOPs
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Optimizing key processes and addressing audit-related deviations using risk-based tools
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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
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