Guideline acts as a combination of the previous two guidelines (Q8 and Q9), giving vontext to the concepts. A Pharmaceutical Quality System is explained for practical application across all manufacturing platforms in an effort to maintain quality.

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

• Regulatory

1. Change Management
2. Continual Improvement of Process Performance and Product Quality
3. Corrective Action Preventative Action (CAPA)
4. Guideline
5. Management Responsibility
6. Pharmaceutical Quality System
7. regulatory