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PDA TR 57-2 PDF

PDA TR 57-2 PDF

Name:
PDA TR 57-2 PDF

Published Date:
03/01/2015

Status:
Active

Description:

Technical Report No. 57-2, (TR 57-2) Analytical Method Development and Qualification for Biotechnology Products

Publisher:
Parenteral Drug Association

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Czech version):
200 business days
SKU:
pda-tr-57-2_2030633
Choose Document Language:
97.50
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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.
File Size : 1 file , 700 KB
ISBN(s) : 9780939459742
Number of Pages : 59
Product Code(s) : 01057-2
Published : 03/01/2015

History

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