PDA Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance) (single user digital version)
- Published
- Nov 2016
- ISBN
- 9780939459933
- Pages
- 36
- PDA Item Number
- 43530
Premium Members: to claim your annual free technical document download, email [email protected] and indicate the document you wish to claim.
- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
Please sign in or become a member to purchase items from the PDA bookstore.
PDA’s newly revised PDA Technical Report No. 56, Revised 2016 Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance provides an overview of the ideal state for broad good manufacturing practices (GMPs) throughout the product lifecycle and as they become more stringent from the discovery/R&D stage through Phase 3 clinical trials to commercial launch.
This report also describes a basic framework for clinical trial manufacturing for sites where full commercial development and/or manufacturing may not be the organizational goal (e.g., university/grant-funded investigators, start-up biotech firms).
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 700 KB)
Click here to order paper ship version (Item no. 01056).
*To purchase licensing, please contact PDA at [email protected].
Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Role of the Pharmaceutical Quality System
- Quality System and cGMP Recommendations by Stage of Development
- Quality System Applicable to Cell Substrate Development
- Conclusions
- References
- Recommended Reading
Figures and Tables Index