Competency information
Details
Review a quality management system (QMS) to ensure compliance with Good Manufacturing Practice (GMP) or equivalent.
Considerations
- 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. |