Risk-Based Cleaning Validation in Biopharmaceutical API Manufacturing

Cleaning Validation (CV) is driven by regulatory expectations to ensure that residues from one product will not carry over and cross contaminate the next product.1,2 Regulatory scrutiny is more rigorous in a multiproduct facility compared to a single product establishment. Companies are usually cited either for not having a sound cleaning validation or not meeting the protocol acceptance criteria. Because failing a protocol acceptance criteria is considered a substantial regulatory risk, companies are forced to spend money and resources even though there is minimal or no product risk.

It is vital for a successful cleaning validation to have appropriate acceptance criteria. In developing the acceptance criteria, companies may adopt a conservative approach either to prove that they have a sound cleaning validation program or to ensure that field data (results) will reflect the acceptance criteria. The Food and Drug Administration’s (FDA) guidance for determining residue limits is that they must be logical (based on understanding of the process), practical, achievable, and verifiable.3 In validation, adequacy of each cleaning procedure requires demonstration that it can reliably and effectively remove or reduce residues to an acceptable level such that residues from the production of one product will not carry over in significant amounts to the next product.

Companies today are faced with the challenge of reducing validation costs in an environment that demands increased compliance with current good manufacturing practices (cGMP). FDA’s initiative in pharmaceutical cGMPs for the 21st Century is a science and risk-based approach to product quality regulation. The risk- based approach will enhance the ability to focus on identifying and controlling critical factors that effect process and product quality.

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