Quality Management System (QMS)

Three-tier structure:

  1. Quality & GDP Manual
  2. Standard Operating Procedures (SOPs)
  3. Documentation & Records

The Quality Organization operates independently of Operations and follows the Plan–Do–Check–Act (PDCA) methodology.

Scope includes:

  • Quality Assurance (QA)
    • Quality Control (QC)
    • Regulatory Affairs (RA)
    • Pharmacovigilance (PV)
    • Health, Safety & Environment (HSE)

Standards and Certifications

  • ISO 9001:2015 - QMS
  • WHO GSDP
  • ISO/IEC 27001:2013 - ISMS