ICH Q6B guidelines for Amino Acid Analysis

Product Characterization, Stability Analysis and Batch Release Testing

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:

USA

•  Well Characterized (Specified) Biological Product concept.

•  Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use.

Europe

•  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

• Annexes

  • Recombinant Erythropoietins:  CHMP/94526/05
  • Somatotropin:  CHMP/94528/05
  • Low molecular weight heparins:  CHMP/BMWP/118264/07
  • Recombinant Interferon alpha:  CHMP/BMWP/102046/06
  • Recombinant granulocyte-colony stimulating factor (GCSF):  CHMP/ 31329/05
  • Recombinant human insulin:  CHMP/ 32775/05

International

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

•  Q9  Quality Risk Management
•  Q10  Pharmaceutical Quality System
  

BSI's technical and scientific staff will respond to all your various requests and needs.

BSI's manufacturing line is compliant with GMP.

Allowing the production of reliable products synthezised in our manufacturing line compliant with GMP


(Good Manufacturing Practice).


BSI's is dedicated to support your R&D with high quality products.