PDA Technical Report No. 57-2, (TR 57-2) Analytical Method Development and Qualification for Biotechnology Products (single user digital version)
- Published
- Mar 2015
- ISBN
- 978093945974-2
- Pages
- 59
- PDA Item Number
- 43519
Premium Members: to claim your annual free technical document download, email [email protected] and indicate the document you wish to claim.
- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
Please sign in or become a member to purchase items from the PDA bookstore.
This Technical Report provides practical, risk-based guidance for the development and qualification portions of the analytical method lifecycle for biotechnology products. Method development begins with defining the requirements for the analytical method and leads to, but does not necessarily finish with, its qualification, which is a documented assessment of method performance.
Guidance for analytical method development and analytical method qualification studies, such as risk-based strategies and priorities, analytical target profile and quality-by-design concepts, target performance criteria, and modern quality expectations is also included in this report.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 541 KB)
Click here to order paper ship version (Item no. 01057-2).
*To purchase licensing, please contact PDA at [email protected].
Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Method Development
- Method Qualification
- Analytical Method Comparability and Analytical Method Transfer
- Method Lifecycle Management Continuum
- Conclusion
- References
Figures and Tables Index