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This Guide aims to provide descriptions of good practices for change management. The modern pharmaceutical quality system described in ICH Q10 is a holistic approach which helps to facilitatethe consistent development and production of high quality pharmaceutical products. The ISPE PQLI GPG: Change Management System describes potential product lifecycle approaches to the change management system element of a pharmaceutical quality system. These approaches can help to achieve the opportunities described in ICH Q10.
Product Details
- Published:
- 2012
- ISBN(s):
- 9781936379460
- Number of Pages:
- 56
- File Size:
- 1 file , 1.7 MB