Competency information


Review a quality management system (QMS) to ensure compliance with Good Manufacturing Practice (GMP) or equivalent.


  • Structure of quality management systems.
  • Quality assurance:
    • Good Manufacturing Practice
    • Good Clinical Practice
    • Good Scientific Practice.
  • The role of the qualified person.
  • Different authorisation types, different requirements for product quality assurance and release of products.
  • Quality system review.
  • BS5750 – ISO 9000, etc.
  • Laboratory of Government Chemist (LGC) and 
  • Pharmassure schemes of intra-laboratory quality assurance.
  • Governance and controls assurance, risk management and critical point control analysis.
  • United Kingdom Accreditation Service (UKAS).

Relevant learning outcomes

# Outcome
# 2 Outcome Use and critically review a quality management system.