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Process Validation Strategy

A process validation strategy is an approach to quality assurance to ensure a new pharmaceutical product will do what it has been designed to do. The strategy has to be supported by documentation offering proof of organizational compliance with these goals.

  1. External Resources

    • The scope of supporting activities and development necessary for a sound process validation strategy requires the commitment of an enormous amount of internal resource and external experts. This makes it imperative that these external experts are examined for proof of their expertise and reliability as a vital resource to the organization's success.

    Validation Strategy

    • The validation strategy can be divided into distinct steps. The identification of the process needs to be validated. The capability of the facility to produce the product or fulfill the necessary phase of the process must be validated. The equipment and processes to be used must be examined. Raw materials must be obtained from certified vendors and tested as necessary. A necessary ongoing process is the use of analytical methods to confirm the validity of the data obtained. Cleaning methods must be examined. Finally, risk assessment must be performed.

    Compliance

    • The Food and Drug Administration (FDA) released a new validation guide in 2008. Validation process was modified and considered an ongoing process. Companies are expected to have either a statistician or an employee trained in statistical control to oversee the continuous process rather than relying on revalidation. The concept is consistent with FDA's 2005 Quality by Design initiative that emphasizes the need to approach quality in a systematic manner based upon product profiles, critical attributes, raw material attributes, control strategy and management of the product's life cycle.

    European Regulations

    • European regulations still require the three-batch model of validation. Companies operating in the global market must be aware of the variations between governing agencies to remain in compliance.

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