Analytical method validation

During the production process of a pharmaceutical product, several analytical methods are normally used to check whether the quality of a component, intermediate or product meet expectations.

For the pharmaceutical industry, method validation is crucial to ensure product quality, therapeutic efficacy and patient safety. To be fit for the intended purpose, an analytical method must meet certain validation characteristics. Typical validation characteristics which should be considered are: selectivity (specificity), linearity, range, accuracy, precision, limit of detection and quantification. Any time a method is transferred, installed, or created on a new or existing system, it must be validated, regardless of any prior validation or qualification work done.

Some commonly made mistakes during the process of validating such methods include:

• Improper design of the validation study
• Insufficient method optimisation
• Failing to investigate all the potential interferences
• Failing to consider the potential changes that could occur in the sample/method being tested.

What we offer

• Establish the intended purpose and characteristics (e.g. robustness, accuracy, precision) of the method together with the customer.
• Make sure all necessary equipment is qualified in our presence.
• Establish a risk-based approach to establish potential interfering factors using the input of Subject Matter Experts.
• Develop test procedures and validation protocols as necessary.
• Write validation reports including re-qualification criteria and monitoring procedures to remain in control.


Dennis Plasman

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Analytical method validation

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