Cder guidance validating chromatographic methods

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Correspondence to: Alankar Shrivastava, Department of Pharmaceutics, Institute of Biomedical Education and Research, Mangalayatan University, Aligarh, Uttar Pradesh, India.

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AMV is a part of the validation process that establishes, through laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical application and provides an assurance of reliability during normal use; sometimes referred to as "the process of providing documented evidence that the method does what it is intended to do." Regulated laboratories must perform AMV to be in compliance with government or other regulators, in addition to being good science.

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.

Validation is also the foundation of quality in the high performance liquid chromatography (HPLC) laboratory, and AMV is just one part of a regulatory quality system that incorporates both quality control and quality assurance (1,2).

The terms "quality control" and "quality assurance" often are used interchangeably, but in a properly designed and managed quality system, the two terms have separate and distinct meanings and functions.

QC usually will require the involvement of those directly associated with the research, design, or production of a product.

For example, in a laboratory-notebook peer-review process a QC group would check or monitor the quality of the data, look for transcription errors, check calculations, verify notebook sign-offs, and so forth.

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This FDA Reviewer Guidance is specifically directed at those FDA officials who check the dossiers for a marketing authorisation and gives instructions on which requirements should be made to the validation of analytical chromatographic methods.

As opposed to QC checks, QA reports are more likely to be performed by managers, by corporate level administrators, or third-party auditors through the review of the quality system, reports, archiving, training, and qualification of the staff that performs the work.

Since the late 1980s, government and other agencies (for example, FDA, International Conference on Harmonization-ICH) have issued guidelines on validating methods.

Quality assurance (QA) can be thought of as related to process quality; whereas quality control (QC) is related to the quality of the product.

In a given organization, it does not matter what the functions are named, but the responsibilities for these two activities should be defined clearly.

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