GxP Engagement: QC Investigations for Microbiology Lab
The Project.
QC Investigations for Microbiology Lab
The Scope.
i-Pharm GxP was engaged under a defined Scope of Work to assess, remediate, and close a significant backlog of QC investigations for a Microbiology lab in preparation for an upcoming FDA audit.
At the point of engagement, the client faced:
- 600 open investigations from the QC Microbiology lab
- A recent QMS harmonisation initiative that had driven a sharp increase in quality events, deviations, and unexpected test results.
The agreed scope included backlog reduction, implementation of new best practices, and upskilling/training of internal personnel to ensure sustainability beyond project completion.
The Solution.
To execute the agreed Scope of Work, i-Pharm GxP deployed a dedicated, outcome-accountable project team, operating as an extension of the Owner’s quality organisation:
- 5 x Microbiology focused Investigators, with specific experience in QC Microbiology, and Elisa testing
The team worked to defined milestones, quality standards, and completion targets aligned to inspection readiness.
The Outcome.
- Full remediation and closure of the QC investigation backlog within the Microbiology lab
- Implementation of improved investigation practices and workflows
- Targeted training and upskilling of internal staff
The site subsequently achieved a successful FDA inspection with no observations.
The work of i-Pharm's GxP team resulted in a successful inspection with no observations.
Find out more
Featured Case Studies
03/07/2023
Case Study: Global VP Regulatory Affairs, Australian Medical Devices Company
A Mid-Sized Australian Medical Devices R&D Company had a requirement for a Global VP of Regulatory Affairs.
Read more
03/07/2023
GxP Engagement: QC Investigations for Microbiology Lab
QC Investigations for Microbiology Lab
Read more
20/06/2023
GxP Engagement: Interim Leadership for growing Biotech
Senior Level Interim Leadership
Read more
