PDA Technical Report No. 42, (TR 42) Process Validation of Protein Manufacturing
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PDA Technical Report No. 42 prepared by PDA Process Validation of Protein Manufacturing Task Force.
This Technical Report (TR) focuses on validation of
biopharmaceutical processes used to manufacture therapeutic proteins and
polypeptides produced from recombinant or non-recombinant cell-culture
expression systems. Selected principles may also apply to other product types,
such as proteins and polypeptides isolated from tissues and body fluids. The TR
provides practical guidance for compliance with CGMP's and ICH guidance's for
the validation of biopharmaceutical processes to the drug substance stage.
2005. Volume 59, Issue No. S-4.
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Table of Contents
Table of Contents:
1.
INTRODUCTION
2. DEFINITIONS
3. PROCESS VALIDATION PREREQUISITES
4.
PROCESS VALIDATION
5. POST-VALIDATION ACTIVITIES
6. DOCUMENTATION
7.
APPENDICES