ICH Guidelines for Validation Parameters are stringent, but implementable

Key Takeaway:

The ICH has laid down important guidelines for validation. These parameters are precise, and are formulated to bring about harmonization of product registration to avoid duplication.

The International Conference on Harmonization of Technical Requirements for Registration ofPharmaceuticals for Human Use (ICH) is a global project that brings the regulatory authorities of the US, Japan and the EU together with experts in the pharmaceutical industry for the purpose of discussing technical and scientific aspects of the area of pharmaceutical products and their registration.

Benefits of harmonization

Harmonization in this area, the stakeholders of this project believe, brings about the following benefits:

• It brings harmonization in the interpretation and application of technical guidelines and requirements for product registration. This reduces or eliminates duplication of the testing carried out during the research and development of new medicines.
• When there is harmonization of these practices; there is an increased accent on the efficacy, quality and safety of animal, human and material resources. This eliminates delays in the global development and availability of new medicines, even as there is an increase in regulatory obligations towards protecting public health.
• Considering the many benefits of harmonization, many countries have adopted theseICH guidelines.

One of the most important areas concerning these ICH guidelines is validation parameters. First, a word about validation: validation is a process that provides "documented evidence that something does what it is intended to do".

Why is validation necessary?

Validation is a form of authentication of a process or method. At the core of the principle of validation is the fact that validation is required to demonstrate that a method used is suitable for its intended use, and that this method provides a degree of assurance of quality.

Validation parameters set out by ICH guidelines

The ICH considers validation of analytical procedures to be a critical requirement in risk assessment and management because of these factors:

• It establishes product-specific acceptance criteria
• It should demonstrate that the analytical procedure is suitable for its intended purpose.

According to the validation parameters set out by the ICH, method validation should consist of the following parameters:

Coming to the validation of Excel spreadsheet applications, the organization should devise a methodology by which it creates these kinds of documentation into their Excel application

What are the types of analytical methods that need to be validated?

The ICH guidelines on validation parameters require that the following types of analytical methods need to be validated:

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