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:

1. INTRODUCTION
2. DEFINITIONS
3. PROCESS VALIDATION PREREQUISITES
4. PROCESS VALIDATION
5. POST-VALIDATION ACTIVITIES
6. DOCUMENTATION
7. APPENDICES