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Quality by design with a focus on biosimilars

Pharmaceutical Technology

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines.

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The imperative of fridge-free vaccines

European Pharmaceutical Review

This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Guaranteeing resilience in vaccine manufacturing The use of foreign materials that require removal before injection are also impracticable.