GxP Engagement: QC Investigations for Microbiology Lab
The Project.
QC Investigations for Microbiology Lab
![GxP Engagement: QC Investigations for Microbiology Lab](https://sitescdn.wearevennture.co.uk/public/i-pharm/mediahub/qc-investigation-for-microbiology-lab-3134367f364c452193e9e28e45f22589.png)
The Case.
Major backlog and gap assessment needed to prepare for FDA audit., with 600 open investigations from the QC Microbiology lab.
As part of a QMS harmonization project. there had been a major increase in quality events, deviations and unexpected test results.
Our Client needed support in reducing the backlog, implementing new best practices and internal upskilling/training.
The Solution.
Project Team Deployed:
- 5 x Microbiology focused Investigators, with specific experience in QC Microbiology, and Elisa testing
![](https://sitescdn.wearevennture.co.uk/public/i-pharm/mediahub/biotech-83e1783762a9422f9b88a861f67285ae.png)
The Outcome.
Successfully remediated the backlog, and trained internal employees which resulted in an inspection with no observations.
![Quotation Marks](/img/Group774.png)
The work of i-Pharm's GxP team resulted in a successful inspection with no observations.