Quality Systems

The BPDF develops compliant manufacturing processes and test methods used in the production of drugs and other biologics, and produces bulk drug substance under Good Manufacturing Practices (GMP) suitable for non-clinical and clinical trials. The BPDF also produces bulk intermediates for further processing, and industrial/agricultural enzymes for GMP manufacturing. A comprehensive Quality System (QS) designed to meet the requirements of 21CFR210/211 and ICH Q10 ensures the quality of processes, test methods and products. The QS includes the following major processes which are applied to all facility activities:

  • Management Review
  • Investigations and CAPA
  • Quality Audits
  • Training and Resources
  • Purchasing and Supplier Control
  • Documentation and Change Management
  • Facilities and Equipment Maintenance
  • Information Systems

Regulatory Affairs

The BPDF Regulatory Affairs (RA) group addresses quality and regulatory compliance at all stages of development. The group works with clients to develop regulatory strategies, provide submission-ready documentation, and support post-submission responses to regulatory bodies.