PDA TR 57-2
- Technical Report No. 57-2, (TR 57-2) Analytical Method Development and Qualification for Biotechnology Products
- Report / Survey by Parenteral Drug Association, 03/01/2015
- Category: PDA
$325.00
$163.00
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.
PDF
All of our standards document are available in PDF (Portable Document Format), an electronic, downloadable format.You will be able to download the file in your account downloads.
Multi-User Access
After purchasing, you have the ability to assign each license to a specific user.
Printable
At any time, you are permitted to make printed copies for your and your members' reference use.
