Leachables in pharmaceutical products could originate from manufacturing items (filters, bioreactors, etc.) used in the production process.

With the increasing use of disposables in the pharma industry, the concern in E&L has also developed considerably. Biopharma industry groups (BPSA, BPOG) have published recommendations when and how to perform E&L studies for these materials. More over, the USP has released chapter <665> and <1665>, which ad dress E&L for production materials in the (bio) pharmaceutical industry.

The different steps in the assessment of the E&L impact of a production line will be outlined In this presentation. In addition, the recommendations of BPOG and USP for these materials will be discussed.

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