Method validation is required during drug development as it provides information about the potency of the medicine, identifies impurities, validates bioavailability, stability and ensures that manufacturing parameters produce consistency in the formulation.Any analytical methods that provide results on the characteristics of pharmaceuticals must be provable and trustworthy since pharmaceutical drugs are used on patients. The pharmaceutical industry has a validation policy which provides documented guidelines about how validation must be undertaken but they use the services of the pharmaceutical testing labs because method validation must be reproducible.
Method validation protocol
Validation of an analytical method is the process through which the pharmaceutical testing laboratory can establish that the performance of the method meets the intended requirement for which it is applicable. It is difficult to validate a method without laboratory testing in a planned manner. Testing laboratories follow a written protocol which states the intended use, validation parameters and analytical procedure to be adopted. Testing laboratories also help the pharmaceutical industry to answer queries of pharmaceutical regulatory bodies related to method validation as they have performed the exact analytical method using standard testing procedure for approval.
Analytical procedures that are used to measure the quality of pharmaceutical products can use any of the available techniques. However, pharmaceutical testing labs evaluate the available procedures and select an analytical method which best suits the intended purpose and which produces quality data. This also enables examination of products so that errors can be prevented at all stages of development. In other words testing laboratories simplify the analytical process even for complex formulations and can help the pharmaceutical industry in the production of quality pharmaceuticals. Due to an increase in the demand of quality pharmaceuticals quality control testing laboratories have also begun to develop analytical methods that can help them to understand which formulations can be released and which need to be discarded or improved.
The protocol used by pharmaceutical testing laboratories clearly states the intended use and procedure to be used for the study of the pre-determined validation parameters and why the chosen method is the best andcan be replicated. In other words method validation means developing a method to measure pharmaceutical substances and to provide proof that what result you want from the drug formulations is exactly the result that it provides. Method validation is necessary because any of the solvents, instruments, ambient conditions, analysts, time etc. used in the analytical method can affect the repeatability and reproducibility of the test results.The analytical method used by the testing laboratory for method validation becomes the official process used by pharmaceutical industry as it will ensure identity, purity, potency, and performance of the pharmaceutical drugs.
The analytical method validation data and reports provided by the pharmaceutical testing laboratories is the documentary evidence which is used for approval of pharmaceutical products. Method validation must meet the globally acceptable criteria as laid down under the ICH guidelines and in various pharmacopoeias.