Conformity Tests According to ICH Guidelines | Quality in Pharmaceuticals

What are ICH Guidelines?

Today, drug development, manufacturing and quality processes are increasingly dependent on international regulations. One of the most widely used authorities in these processes is the ICH (International Council for Harmonization) guidelines. So, what are ICH guidelines? Which conformity requirements do they include? And which tests should be performed according to these guidelines?

What are ICH Guidelines?

ICH (International Council for Harmonization) is an organization established to establish global standards for the safety, quality and efficacy of medicines. This structure, created in cooperation with authorities such as the US FDA, the European EMA and the Japanese MHLW, operates to harmonize pharmaceutical regulations and eliminate the double testing requirement.

ICH guidelines are categorized under four main headings:

• Q Series Quality
• S Series Safety
• E Series Efficacy
• Series M Multidisciplinary

What are the ICH Conformity Requirements?

Certain conditions must be met for a medicine to be developed and approved in accordance with ICH guidelines. These requirements are generally summarized in the following areas:

1. Pharmaceutical Quality Management (ICH Q10): Production and quality processes must be carried out within a quality system.
2. Stability Testing (ICH Q1): Tests that demonstrate the safety and efficacy of the product throughout its shelf life.
3. Validation Processes (ICH Q2): Accuracy, precision, repeatability of analytical methods.
4. Impurity Profile (ICH Q3): Limitation of undesirable substances in pharmaceuticals.
5. Bioequivalence and Clinical Testing (ICH E6): Compliance of clinical trials with ethical rules and scientific methods.

Basic Tests Applied within the Scope of ICH

The scope of tests to ensure ICH conformity requirements is as follows:

• Stability Tests: Resistance to temperature and humidity conditions.
• Impurity Tests: Detection of organic, inorganic and residual solvents.
• Analytical Method Validation: Measurement of method validity.
• Bioavailability and Bioequivalence Tests: Evaluation of the behavior of the drug in the body.
• Microbiological Tests: Sterility and microbial limit analysis.

All of these tests must be planned, reported and documented according to ICH guidelines. In this way, the product can be accepted in global markets.

Why is ICH Compliance Important?

• Validity in the International Market: ICH standards are recognized by global authorities.
• Regulatory Compliant Production: Provides criteria that are accepted in regulatory processes.
• Scientific Reliability: Ensures that tests have a scientific basis.
• Prevents Repeated Testing: Prevents repetition of the same test in different countries.

Nanolab Laboratories Group continues to provide services within the scope of Drug Analysis. You can also consult us about Nitrosamine Analysis.

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