It’s all too common: full lots of injectable drug products are rejected or recalled because of visible particulates. Particulate contamination attributed to incompatibility between elastomer components and injectable drug products can be a source of risk and variability, potentially compromising the quality of the drug and the safety of patients.
Such contamination can also impact a drug manufacturer’s bottom line via increased costs, lost batches and manufacturing inefficiencies. Furthermore, product recalls can have a negative impact on patient confidence, shareholder value and market share.
This scientific, risk-based approach is fast becoming an essential strategy to bring high quality therapeutics to market quickly and efficiently. A QbD approach delivers an improved, data-driven output, providing manufacturers with superior product and process understanding that minimises risk, emphasises patient-critical quality requirements and preserves drug product effectiveness.
In an industry in which patient-centricity is paramount, quality must be top of mind from the very beginning. The adoption of QbD principles in the design and manufacturing of packaging components can help to ensure that a drug’s packaging is designed to meet these stringent expectations.
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