Diane Paskiet, director, scientific affairs, West Pharmaceutical Services explains how to understand risk from extractables and leachables (E&L) and the key quality considerations when designing E&L studies
Materials that have direct or indirect contact with a drug or biologic product can leach harmful substances into the final pharmaceutical product. Substances that leach can originate from various materials, at any point in the supply chain and throughout the product’s lifecycle. Constituents that migrate from primary packaging into the final product when manufactured and stored under its normal conditions are referred as leachables. Typically, leachable compounds are found in trace amounts yet can have a negative impact on pharmaceutical quality with potential to compromise patient safety. Any component used during manufacture, storage, shipping and administration to the patient can be implicated as a source of leachables.