Q8(R2): Pharmaceutical Development
Abstract
International Conference on Harmonisation (ICH) Q8(R2) provides guidance on the contents of the Pharmaceutical Development section in regulatory submissions, that is, new drug applications (NDAs) or marketing authorization applications (MAAs). The guideline thereby proposes a new approach both in pharmaceutical development and subsequently in quality control (QC) within the commercial manufacturing arena, as the development process is now specifically designed to support it. Pharmaceutical companies are therefore encouraged to apply a systematic, scientific approach to drug development. This chapter describes the two development paradigms (quality by testing (QbT) and quality by design (QbD)) that contain many of the same elements, and focuses specifically on those elements important to a QbD approach. It exemplifies how rational selection criteria for choosing process technology can be defined based on public and prior knowledge. In addition, the proposal for a manufacturing classification system (MCS) provides additional insight, including the use of appropriate expert systems.
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Removal and/or inactivation can be used to reduce the content of residual HCD in the virus passaging, cell culture, production, and purification processes.
“During the production process, methods such as removal and/or inactivation can be used to reduce the content of residual HCD in the virus passaging, cell culture, production, and purification processes [9].”
From Evaluation of the Efficacy of the Vaccine Production Process in Removing Residual Host Cell DNA from the Vero Cell Rabies Vaccine (2024) · cites this paper as [9]
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Levothyroxine sodium pentahydrate tablets – formulation considerations
Kaur, N., & Suryanarayanan, R. (2021) · Journal of Pharmaceutical Sciences · doi:10.1016/j.xphs.2021.08.006 · Cited by 19 · see citing works
Li, J., Pan, R., Yue, F., Gao, T., Wu, X., Shi, L., Wang, Y., Zhao, D., Lan, Z., Chen, H., et al. (2024) · Vaccines · doi:10.3390/vaccines12121379 · Cited by 8 · see citing works
- Authors
- Holm, P., Allesø, M., Bryder, M. C., & Holm, R.
- Affiliations
- Lundbeck (Denmark) (DK)
- Venue
- ICH Quality Guidelines
- Publisher
- Wiley
- Published
- 2017-09-27
- Pages
- 535-577
- OpenAlex
- W2762472815
- Cited by
- 142
- References
- 0
- Citations by year
- 2026: 16 · 2025: 19 · 2024: 11 · 2023: 4 · 2022: 11 · 2021: 15 · 2020: 19 · 2019: 13 · 2018: 11 · 2017: 10 · 2016: 7 · 2015: 4 · 2014: 1
- Type
- other
- Language
- en
- Open access
- closed
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Physical Sciences › Environmental Science › Environmental Chemistry › Chemistry and Chemical Engineering
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Keywords
- drug development, quality by design, new drug applications, marketing authorization applications, process technology selection, expert systems, regulatory submissions
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