By Irinia Prudnikova, Associate Director, Analytical Research & Development (R&D), Pharmaceutics International
Sterile fill/finish is considered among the most critical steps in the parenteral production process, ensuring patient safety, maintaining pharmacological efficacy, and product quality. Drug product development and subsequent production rely on a number of integrated process elements operating in a systematic and coordinated environment. Without a doubt, analytical support is one of the key process elements. Its importance and uniqueness are derived from the fact that it is required at all stages of the product’s life cycle, from the early development to commercialization stages.