Enhanced Diagnostic Tools
Analytical services at BSI are conducted in accordance with Good Laboratory Practice (GLP) or Good Manufacturing Practice (cGMP) to produce data that fulfil the principles required by the appropriate regulatory guidelines, for example:
Well Characterized (Specified) Biological Product concept.
Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use.
Production and Quality Control of Medicinal Products derived by recombinant DNA technology 75/318/EEC 1995.
Guideline on Development, Production, Characterization and Specifications for Monoclonal Antibodies and Related Products. EMEA/CHMP/BWP/157653/2007
Guideline on similar biological medicinal products. EMEA/CHMP/437/04
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Quality Issues EMEA/CHMP/BWP/49348/2005
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non-clinical and Clinical Issues EMEA/CHMP/BMWP/42832/2005
ICH ( International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ) Guidelines, particularly:
Q1A(R2) Stability Testing of New Drug Substances and Products
Q2(R1) Validation of Analytical Procedures: Text and Methodology
Q3A (R2) Impurities in New Drug Substances
Q3B(R2 Impurities in New Drug Products
Q3C(R4) Impurities: Guidelines for Residual Solvents
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Q5E Comparability of Biotechnological/Biological Products subject to Changes in their Manufacturing Process
Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Q8 (R1) Pharmaceutical Development
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