Why Analytical Method Development and Validation is Critical to Pharmaceutical Development?
Analytical method development and validation can be referred to as continuous and inter-dependent tasks linked with quality control, R&D, and quality assurance departments. Analytical method development and validation are one of the most important elements of any pharmaceutical program. Although analytical method development is considered to be routine work, it is quite beneficial in contributing to the overall development time and cost efficiency of the pharmaceutical program.
What is Analytical Method Development?
Analytical method development refers to the process of choosing an appropriate procedure to determine the composition of a formulation. It is a process that proves that an analytical method is acceptable to be used in the laboratory to measure the concentration of subsequent samples. Analytical methods are meant to establish the identity, purity, potency, and physical characteristics of drugs. Analytical methods are developed to support drug testing against specifications during manufacturing, quality release operations, and long-term stability studies.
Analytical method development is an uninterrupted procedure that advances simultaneously with the progression of the drug product and the aim of this procedure must mirror the stage of drug development. As the procedure of drug development evolves, the analytical methods are expanded and refined based on enhanced drug product knowledge and API. One thing that must be kept in mind while carrying out analytical method development is that it should meet the appropriate regulatory guidelines without being feeble and complicated.
Validation of the Analytical Method
The validation of an analytical method determines the scientific soundness of the measurement or characterization. It demonstrates that an analytical method is measuring the correct substance, in the correct quantity and in the appropriate range for the intended samples. It helps the analyst to understand the behaviour of the analytical method and to establish its performance limits.
To perform the validation of an analytical method, laboratories must follow a written standard operating procedure (SOP), describing the process of conducting the validation. Using qualified and calibrated instrumentation with a corresponding operating SOP is a must for laboratories. The type of analytical method and technique used determines the nature and extent of the validation studies. Assay, identification, and determination of impurities are some of the most common methods used for validation. The validation method includes various validation parameters. Some of them as recommended by the FDA, USP, and ICH are as follows:
Need for Analytical Method Development and Validation
While analytical procedures play a very important role in uniformity, management of risk assessment and establishing product-specific acceptance criteria and stability of results, the validation method helps in demonstrating whether the analytical procedure is suitable for the intended purpose. Hence, analytical method development and validation are quite beneficial in improving precision and reducing biased errors. They can also further assist in avoiding expensive and time-consuming exercises.
Analytical method development and validation are crucial to pharmaceutical development because of the following factors:
• International competition
• Maintaining the standard of products in high commercial and market value
A holistic approach is extremely necessary for an analytical method development and validation process to be successful. However, one challenge that is often encountered when carrying out these processes is that the analytical method is usually developed by the R&D department while validation comes under the responsibility of the quality assurance and quality control team. Hence, it is significant that all groups work as one team.
In addition to this, the methods of analytical development and validation are not robust enough. As a result, if robustness is not introduced into the method early in the development phase then there is a high probability that the results will lack efficiency in quality testing thus, resulting in a lengthy and complicated validation process.
Analytical method development helps in understanding the critical process parameters and minimizing their influence on accuracy and precision. The validation method, in contrast, substantiates the analytical method for a variety of concentrations so that alterations in concentration or formulation do not require further authentication.
Moreover, the validation method helps in producing results in known uncertainties. These results are extremely important for continuing the development of drugs as they define the emerging knowledge base pertaining to the product. All these factors make analytical method development and validation crucial for pharmaceutical development.
ref: https://medium.com/@renytamang1122/why-analytical-method-development-and-validation-is-critical-to-pharmaceutical-development-8406e9ab6ef4
