Qualiculture

Phama Biotech Services

ASSESSMENT OF LABORATORY CONTROLS

We offer a protocol-based assessment of laboratory controls established at pharmaceutical and biotech manufacturing firms.

It includes in-depth onsite review and assessment of quality control testing performed by laboratory to uncover the gaps which can compromise the accuracy and completeness of the analytical data. It also includes the evaluation of analytical methods for adequacy and suggestions for improvements.

We also support the pharma and biotech companies in the development of corrective and preventive action plans for the identified gaps along with product impact assessment.

Review and assessment of Analytical data (chromatographic and non-chromatographic analysis) for accuracy and completeness
Review and Assessment of Controls exercised over computerized systems used in quality controls laboratories
Comprehensive assessment of laboratory practices
Quality Control test Samples handling and Management
Analytical Method Validation
Analytical Instrument Qualification
Analytical Method Validation
Test Methods and Procedures
Analytical data management (Hard copy and Electronic Data)
Reporting and Documentation of Results