The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
News|Articles|February 1, 2010
Pharmaceutical Technology Europe
- Pharmaceutical Technology Europe-02-01-2010
- Volume 22
- Issue 2
Implications and Opportunities of Applying QbD Principles to Analytical Measurement
The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
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The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
The merits of applying quality by design (QbD) to pharmaceutical products and processes is a topic of significant mutual interest to both pharmaceutical manufacturers and regulatory agencies. The pharmaceutical industry is currently embracing QbD concepts to help improve the robustness of manufacturing processes and to facilitate continuous improvement strategies to shape and enhance product quality and manufacturing productivity. As such, both industry and regulators recognize the benefits of adopting a QbD approach to drug-product development and manufacture, with key concepts described in International Conference on Harmonization (ICH) guidelines Q8(R1) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.
Articles in this issue
almost 17 years ago
EU pricing dilemmasalmost 17 years ago
Is change good for you?almost 17 years ago
Newsalmost 17 years ago
Multivariate data analysis easily retrieves insight from a wealth of dataalmost 17 years ago
Rise of the robotsalmost 17 years ago
Your predictions for 2010almost 17 years ago
Commercialising cellular therapies fasteralmost 17 years ago
Cushioning pharma's fall from the patent precipicealmost 17 years ago
Biopharmaceuticals: saving the future of our industryalmost 17 years ago
Achieving site-specific PEGylationAdvertisement
Related to this article
The FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.
USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.
Almac Clinical Services’ clinical supply strategy won the 2026 CPHI Award for Supply Chain Excellence. Nishma Patel, supply chain solutions manager, explains the benefits and challenges of the company’s just-in-time manufacturing solution.
The pharmaceutical supply chain is a complex system with high stakes. USP provides insights on how it is helping industry navigate global disruptions and procurement issues.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
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