Roadmap for implementation of quality by design (QbD) for biotechnology products

Author:

Rathore Anurag S.

Publisher

Elsevier BV

Subject

Bioengineering,Biotechnology

Reference49 articles.

1. Woodcock, J. (2005) Pharmaceutical quality in the 21st century – an integrated systems approach. In AAPS Workshop on Pharmaceutical Quality Assessment – A Science and Risk-Based CMC Approach in the 21st Century

2. Department of Health and Human Services, Food and Drug Administration (2004) PAT Guidance for Industry – A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance

3. International Conference of Harmonisation (2008) ICH Harmonised Tripartite Guideline: Q8(R1) Pharmaceutical Development (http://www.ich.org/LOB/media/MEDIA4986.pdf)

4. International Conference of Harmonisation (2005) ICH Harmonised Tripartite Guideline: Q9 Quality Risk Management (http://www.ich.org/LOB/media/MEDIA1957.pdf)

5. International Conference of Harmonisation (2008) ICH Harmonised Tripartite Guideline: Q10 Pharmaceutical Quality Systems (http://www.ich.org/LOB/media/MEDIA3917.pdf)

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