Validating a method

The DQ phase usually is performed at the vendor's site, where the instrument is developed, designed, and produced in a validated environment according to good laboratory practices (GLP), current good manufacturing practices (c GMP), and ISO 9000 standards.

Whilst there appears little laboratory input into the DQ phase, it is worthwhile ensuring the instrument vendor can advise / aid in installation, training, servicing and on-going support during the lifetime of the instrument.

In practice, a known method with known, predetermined specifications is used to verify that all of the modules are performing together to achieve their intended purpose.

OQ and PQ frequently blend together in a holistic approach, particularly for injector linearity and precision (repeatability) tests, which can be conducted more easily at the system level.

More recently, new information has been published, updating the previous guidelines and providing more detail and harmonization with International Conference on Harmonization (ICH) guidelines (5,6).

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Mike Swartz (Ariad Pharmaceutical, Cambridge, MA) and Scott Fletcher (Technical Business Development Manager, Crawford Scientific), present an Introduction to Chromatographic Validation.

A well-defined and documented validation process can provide evidence not only that the system and method is suitable for its intended use, but can aid in transferring the method and satisfy regulatory compliance requirements.

"The process of providing documented evidence that something does what it is intended to do." Validation is also the foundation of quality in the chromatographic laboratory, and AMV is just one part of a regulatory quality system that incorporates both quality control and quality assurance (1,2).

First, fixed parameters, for example, length, weight, height, voltage inputs, pressures, and so forth are either verified or measured against vendor-supplied specifications.

Because these parameters do not change over the lifetime of the instrument, they usually are measured just once. Finally, instrument function tests are undertaken to verify that the instrument (or instrument modules) meets vendor and user specifications.

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