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 completenessReview and Assessment of Controls exercised over computerized systems used in quality controls laboratoriesComprehensive assessment of laboratory practicesQuality Control test Samples handling and ManagementAnalytical Method ValidationAnalytical Instrument QualificationAnalytical Method ValidationTest Methods and ProceduresAnalytical data management (Hard copy and Electronic Data)Reporting and Documentation of Results