Analytical Method Development and Validation for durg development

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Analytical methods are required for a variety of reasons during drug development projects. The regulatory agencies expect that any investigational new drug or new drug product contains what is stated on the label and in the correct amount over the shelf-life of the API or product. There are also further expectations that it does not contain any harmful contaminants and has not been otherwise adulterated. ICH rules must ultimately be complied with regarding impurities and degradation products. Pharmacopeia tests are also mandatory, even for investigational drugs and drug products.

The regulatory authorities are aware of the burden of developing such tests and they allow some discretion as to when certain test methods and specifications should be applied. In general terms, full commercial-style specifications are required for Phase III studies and beyond. Less stringent specifications and tests may be acceptable for Phase I and Phase II.

For Phase I manufacture (API or pharmaceutical product), fully validated analytical methods are not required. However, there is an expectation that the methods used will be appropriate for their intended use, and capable of distinguishing between acceptable and unacceptable batches.

FinnBrit Consulting can advise clients on the appropriateness of their analytical methods and specifications for a particular stage in the project.

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