Microbiology Laboratory Assessment

Our Projects

Review SOP for adequacy

Assess Practices for Compliance i.e. Procedure Vs. Practices

Real-time evaluation of microbiology practices

Coverage of key tests – Microbial Testing, Environmental Monitoring, Sterility, BET and aseptic practices

Enhancements to procedures and Training approach

Trouble shooting of Legacy issues

Demonstration of the good microbiology practices and Investigations

Real-time feedback on the practices potentially result in regulatory findings and corrections

Rationalization of sampling plans (Cleanrooms, Water, Utilities, In-process Bioburden etc.)

Simplification of test documentation

Harmonization of general test procedures inline global regulations and industry best practices

Microbiology in aseptic manufacturing – Sampling and Sterility Assurance