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ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI) from Concept to Continual Improvement Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System PDF
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Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 2012
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.
| Published | 2012 |
|---|---|
| ISBN(s) | 9781936379460 |
| Number of Pages | 56 |
| File Size | 1 file , 1.7 MB |
| Note | This product is unavailable in Russia, Belarus |
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