|
ISPE Events
Guidance Documents
Training
Pharmaceutical Engineering Magazine
Online Learning
Publications
Glossary
|
Young Professionals
Affiliates and Chapters
Suppliers
Communities of Practice
Regulators
Volunteers
Students
|
Employers
Job Seekers
Professional Certification
|
ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
 |
Published: October 2011 |
| Formats | Member Price | Nonmember Price | |
|---|---|---|---|
| Bound Version | $145 / €115 | $405 / €345 | |
| Individual Download PDF | $145 / €115 | $405 / €345 | |
| Which format is right for me? | |||
The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification describes how organizations can move from established baseline practice to a more efficient science- and risk-based framework. It illustrates the application of Quality Risk Management to traditional commissioning and qualification practices, linking traditional terminology and approaches to the newer science- and risk-based specification and verification terminology and approaches applied in ICH Q8, Q9, and Q10, ASTM E2500, and ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment.
The approach described in the ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification allows companies to achieve the benefits of a science- and risk-based model by outlining bridging strategies for organizations with well-established qualification-based Quality Management Systems and providing a roadmap showing the spectrum of potential approaches for this transition.
Mapping Document for ISPE Specification and Verification Guides
This free document explains the relationship between the following ISPE Guides.
- ISPE Baseline Guide, Volume 5: Commissioning and Qualification (Baseline Guide Volume 5)
- ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment (FSE Guide)
- ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification (Applied Risk Management Guide)
- Download Mapping Document (
284 KB)
