GMP Operations and Quality Control

GMP material supply represents one of the major costs and risks for a biopharmaceutical product developer. Technical capabilities, on-time performance and GMP compliance are all needed for success. Alava has the experience to assess, install and manage all aspects of GMP drug substance (API) and drug product manufacturing, testing and distribution.

  • Manufacturing planning and management (including person-in-plant)
  • Batch record preparation
  • Quality Control systems and sample management
  • Specifications and reference standards
  • Stability studies: real-time, accelerated/stressed, shipping and product compatibility
  • Aseptic operations, QC microbiology and environmental monitoring
  • Adventitious agent testing for banks and batches
  • Supply Chain (inventory management, shipping, storage, distribution)
  • Method and Process Validation