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This is part two of a three-part series about how recent updates to ICH Q2(R2) and Q14 can be applied to the development and validation of leachables methods. You can find part one here.

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Since 25 August 2023, the revised European Union guidelines for Good Manufacturing Practice (EU GMP) Annex 1 has imposed requirements to implement a Contamination Control Strategy (CCS) across the facilities of finished drug product manufacturers, to ensure higher quality and sterility of medicinal products for human and veterinary use.

Part I – Background and History
The final step in the drug packaging extractables and leachables (E&L) journey is the determination of the actual leachables that are observed in the drug during the product’s shelf life. This is typically determined with a leachables stability study that incorporates accelerated and normal storage conditions, with the results of the accelerated conditions often being used to support a regulatory submission. However, before any of these activities take place, methods to determine a wide range of potential leachables (organic and inorganic) need to be developed and validated for this specific use.

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Ensuring the sterility of medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on patients, as well as the potential for costly product recalls. The importance of control strategies to ensure drug products remain sterile has also been reiterated recently by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines:

• FDA: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
• EU GMP Annex 1 Manufacture of Sterile Medicinal Products