GxP Engagement: QC Investigations for Microbiology Lab
The Project.
QC Investigations for Microbiology Lab
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
The Outcome.
Successfully remediated the backlog, and trained internal employees which resulted in an inspection with no observations.
The work of i-Pharm's GxP team resulted in a successful inspection with no observations.
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