Upgrading Pharmaceutical Test Methods Using a Contract Research Organization

Methods validation guidelines are becoming more standardized across regulatory jurisdictions. With the adoption of the International Conference on Harmonization's (ICH) guidelines, test methods for mature drugs must be validated to current regulatory standards. This article discusses how a sponsor company can select and partner with a CRO to evaluate, redevelop, and revalidate the analytical test methods used for its mature drug substances and drug products.

By Paul Newton, Ph.D.

In the highly regulated pharmaceutical industry,methods validation documentation must support the suitability of analytical test methods for drug substances and drug products. A suitable method consistently provides accurate results under a normal range of operating conditions, with the goal of evaluating samples to determine whether they meet the product's specifications. Validated test methods ensure that products are safe and effective and have appropriate storage conditions and expiry periods.

Methods validation guidelines are becoming more standardized across regulatory jurisdictions, especially since the adoption of the International Conference on Harmonization's (ICH) guidelines. Although these guidelines are typically invoked for new pharmaceuticals, test methods for mature drugs should also be validated to current regulatory standards. If methods are not updated, FDA can issue 483s to companies that either do not use appropriate methods or lack satisfactory validation documentation. In Europe, companies must reregister drug products every five years to ensure that analytical methods for mature drugs meet current standards.

This article discusses how a pharmaceutical (sponsor) company can select and partner with a CRO to evaluate, redevelop, and revalidate the analytical test methods used for its mature marketed drug substances and drug products. To begin the process, the sponsor should provide the CRO with background information regarding its existing products and test methods. The CRO's responsibilities can include evaluating the suitability of any questionable test methods that may require enhancement or replacement, enhancing existing methods, developing new methods, validating methods, and transferring new methods to the appointed sponsor sites and writing the corresponding documents.

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