Expert View: Data integrity in the QC micro laboratory
The quality control (QC) microbiology laboratory plays an essential role in pharmaceutical manufacturing and product release. Jessica Rayser discusses the importance of data integrity to ensure safe and effective products are manufactured.
THE QC microbiology laboratory is responsible for:
- environmental monitoring (sampling, bioburden counts, microbial identifications and tracking and trending of data)
- investigating contamination events and deviations from specifications
- implementing and validating QC methods and testing based on release specifications.