The Lifecycle of a Pharmaceutical Test Method

1. Method Development

This is the initial stage where the test method is developed based on the specific requirements of the pharmaceutical product. It involves determining the analytical technique, selecting appropriate instruments and reagents , and establishing the method parameters.

 

2. Method Validation

Once the test method is developed, it needs to be validated to ensure its accuracy , precision , specificity, and robustness. This involves conducting a series of experiments to demonstrate that the method can consistently produce reliable results.

 

3. Method Transfer

After validation, the test method may need to be transferred from one laboratory or site to another. This step ensures that the method can be successfully implemented in different locations while maintaining its performance characteristics.

 

4. Method Verification

In some cases, a pharmaceutical company may need to verify an already established test method from a compendial source (such as USP or EP ) for their specific product or process. This step involves conducting experiments to demonstrate that the compendial method is suitable for their intended use.

 

5. Routine Use

Once a test method has been validated or verified and transferred if necessary, it can be used routinely for quality control purposes in pharmaceutical manufacturing. This involves performing regular testing on raw materials, intermediates, and finished products to ensure compliance with regulatory requirements.

 

6. Method Maintenance

Over time, changes may occur in manufacturing processes or regulatory guidelines that require modifications to the test method. It is important to periodically review and update the method as needed to ensure its continued suitability and reliability.

 

7. Method Retirement

If a pharmaceutical product reaches the end of its lifecycle or if a new analytical technique becomes available, it may be necessary to retire an existing test method. This involves discontinuing its use and documenting this decision in accordance with regulatory requirements.

 

Read also: pH and pKa Concepts in Method Development

 

Resourece Person: Ershad Moradi