Regulatory Guidelines

Product Characterisation, Stability Analysis and Batch Release Testing

SGS M-Scan has extensive experience in providing characterisation data for regulatory submissions, stability or product release testing. Analytical services 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:

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 m.wt. 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

     

    New annexes to cover Mab, FSH and Interferon beta are under review.

USA : 

  • Well Characterised (Specified) Biological Product concept .

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

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

Advice on suitable analytical protocols to comply with the regulatory guidelines can be provided-gained from over 25 years experience of performing studies for regulatory purposes.