GxP Engagement: QC Investigations for Microbiology Lab
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.
Project Team Deployed:
- 5 x Microbiology focused Investigators, with specific experience in QC Microbiology, and Elisa testing
The work of i-Pharm's GxP team resulted in a successful inspection with no observations.