Quality (QA and QC)

  • GMP/GTP/GLP gap assessments, audits

  • CMO/CTO/raw material selection and qualification

  • Quality Assurance:

    • quality management systems development and operations;

    • document control

    • supplier management

    • GxP training

    • change management

    • deviations/investigations & CAPA

    • OOS & OOT

    • material & lot disposition

    • risk management

    • validation oversight

  • Quality Control:

    • sample handling and accountability

    • analytical methods identification/qualification/validation

    • environmental monitoring program

    • stability program for raw materials

    • stored process intermediates

    • drug substance

    • final formulated bulk and final product

    • forced degradation and photostability studies

    • testing for sterility, pyrogens, and adventitious agents

    • aseptic process validation

    • reference standard establishment and qualification

    • cold chain custody management (protected services container identification and qualification)