Method validation is the process utilized by scientists and researchers to maintain accuracy and reliability for method development in the field of drug discovery and development. Test method validation such as analytical procedure is an essential aspect of the final results in the development of pharmaceuticals. Scientists are required to use the right techniques that are viable in correlation with performance quality. The consequent analytical method needs to be assessed to detect pharmaceutical quality. The methods used are viable, and verification regarding their appropriateness is done before analysis.

The analytical procedure needs test method validation in case of any alteration in the drug route of synthesis, analytical process, and composition. Analytical procedures require revalidation in the following circumstances:  

• In manufacturing units, the method can be incorporated for procedural use.
• Alteration in the environment of the verified method through alteration utilizing varied formulation matrix, diverse starting material, manufacturing procedure, etc.
• The difference in the chromatographic condition of the established method is necessary to verify if accurate and reproducible results are achieved in laboratories run by experts.

Importance of Analytical Procedures

Analytical procedure verification is necessary due to the reasons given below: 

1. Before usage in routine testing and upon transferring of the analytical procedure to a different laboratory.
2. Upon alteration of the conditions of pharmacopeial method. 
3. When assessing the registration sample and accelerated stability test batches employment of well-characterized and completely verified FDA analytical method validation is crucial for accurate results.
4. Every analytical process possesses its characteristics, which differ from analyte to analyte.
5. Product quality can be validated. 
6. To gain product approval from international organizations.
7. It is a compulsory registration mandate for any pharmaceutical product. 
8. Results in mitigation of minimum sample failures, quality cost, increased efficiency, rejection, productivity, and higher analyst awareness.
9. Compulsory registration mandate for any pharmaceutical product within the regulatory market

Measures Scientists Need to Follow 

Below are the potential measures for full analytical method validation.

1. Establish a verification protocol or working process for the validation.
2. Formulate the scope, application, and purpose of the method.
3. Determine the performance condition and approval criteria.
4. Define verification experiments.
5. Validate related performance qualities of equipment.
6. Quality materials, such as reagents and standards.
7. Carry out pre-verification experiments.
8. Alter technique conditions or/and approval criteria if required.
9. Perform complete external and internal verification experiments.
10. Formulate criteria for re-verification, kind, and frequency of organizational suitability tests.
11. Record verification experiments and results in the validation.

In the context of the release of commercial samples and longevity data, analytical method validation plays a crucial function in the pharmaceutical industry, and this is why this information is required in correlation with acceptable procedural standards through method validation.

Numerous global regulatory organizations have kept ethical standards for purposes such as authentication and approval. In the USA, Food and Drug Administration (FDA) lays down the guidelines contract research organizations need to follow to ensure the right drugs are reaching the market!