PDA Technical Report No. 56 (TR 56) Application of Phase-Appropriate Quality Systems and CGMP to the Development of Therapeutic Protein Drug Substance (single user)

How and when to apply GMPs to early-phase therapeutic drug substances is a challenging proposition. PDA Technical Report No. 56 provides answers and guidance to those dealing with the challenge. The report covers phase-appropriate CGMPs during the manufacturing of therapeutic protein drug substance (biological active substance) from the R&D stage through completion of phase 3 clinical trials. The scope also includes implementation of a pharmaceutical quality system that ensures the safety and quality of products intended for use in clinical trials. Finally, it provides the basis for subsequent assurance of the equivalence of products used in trials to products submitted for marketing approval. This report will focus on current best practices.

This is the second Technical Report released under PDA's Paradigm Change in Manufacturing Operations ^SM (PCMO^SM).

1. Introduction
2. Glossary of Terms
3. Role of Quality Systems
4. Quality System and CGMP Recommendations by Stage of Development
5. Conclusions
6. Appendix: Quality Systems Applicable To Cell Culture Development
7. Bibliography & Selected Readings
8. Figures and Tables Index