Transcription of ICH Q10 Pharmaceutical Quality System
{{id}} {{{paragraph}}}
Example: tourism industry
ICH Q10 Pharmaceutical Quality System
International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human UseICH Q10 Pharmaceutical Quality System (PQS)2 ICH Q10 PQS Guideline Background Objectives Scope Content Implementation Conclusion3 Background high level more visionary less prescriptive flexible regulatory approaches ICH Q8 Pharmaceutical Development ICH Q9 Quality Risk Management ICH Q10 Pharmaceutical Quality System Vision Move from regulatory guidance to scientific guidance A harmonized Pharmaceutical Quality systemapplicable across the lifecycleof the product emphasizing an integrated approach to qualityrisk managementand science Companion guidelines 4 Background(continued) ICH Q8 Finalized November 2005 ICH Q8(R1) (Step 2)
A change management system ensures continual improvement is undertaken in a timely and effective manner. It should provide a high degree of assurance there are no unintended consequences of the change Change Management should, as appropriate for the lifecycle stage: Use Quality risk management (Q9) to evaluate proposed changes
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: