Chapter 7. Product Verification and the Role of Qualified Personnel
Published Online: 24 DEC 2009
DOI: 10.1002/9780470773031.ch7
Copyright © 2008 John Wiley & Sons, Ltd
Book Title
Quality Systems and Controls for Pharmaceuticals
Additional Information
How to Cite
Sarker, D. K. (2009) Product Verification and the Role of Qualified Personnel, in Quality Systems and Controls for Pharmaceuticals, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470773031.ch7
Publication History
- Published Online: 24 DEC 2009
- Published Print: 15 AUG 2008
ISBN Information
Print ISBN: 9780470056929
Online ISBN: 9780470773031
- Summary
- Chapter
Keywords:
- effective QA and qualified person (QP) skills;
- product verification and qualified personnel (QP) role;
- tablet manufacture and batch documentation;
- batch documentation - product form and dosage strength;
- Standard operating procedures (SOPs);
- European Medicines Evaluation Authority (EMEA);
- drug manufacture processes and working standard operating procedures (wSOPs);
- QA administration and management policies
Summary
This chapter contains sections titled:
Batch documentation
Standard operating procedures
Guides, overviews and validation plans
The duties of the qualified person