Analytical Method Validation in Pharmaceuticals
Analytical Method Validation in Pharmaceuticals is very important in the development of any pharmaceutical product. Analytical method validation is important because it enables all the resources in the laboratory that are used in the development of pharmaceuticals to be optimized. Method validation is something that regulatory agencies require of every pharmaceutical developer. It is required in certain stages in drug approval to ensure the expected results are achieved. Method validation can be defined as a process of coming up with different demonstrations that prove analytical procedures being used are suitable for the purpose they are intended for. The importance of this is that it enables improvements to be made to the methods being used. This makes it possible for drug development to be efficient.
Analytical methods are useful for several reasons. They are used in the identification of drugs, determining whether the drugs are pure or not, analysing the physical characteristics of different drugs and most importantly, analytical methods are important in determining the potency of each and every drug developed. These methods are normally developed against a set of specifications which enable the developers to come up with effective methods. There are different types of analytical methods. These include: quantitative, for the purpose of checking for impurities, quantitative tests for active moiety in different samples, Identification tests and the limitless kind of tests that are used for the purpose of controlling impurities.
Validation normally entails the demonstrating of whether or not an analytical method is scientifically sound. It is a requirement in the process of regulatory submission. However, the extent to which it is required in this process varies. The validation practice is intended to show that the analytical method in question is able to measure the right sample, in the right amount and in the specified range for different types of samples. A Standard Operating procedure (SOP) must be used if a laboratory intends to carry out the validation process. This is because the SOP outlines how the validation should be done in detail. It is also important for the laboratory to have calibrated and up to date equipment when doing validation. Before validation, it is also very important for the analyst to make sure they have a test method document and an approved protocol. A protocol mainly states what the parameters that are going to be tested, methods that will be used in assessing the parameters and which acceptance criteria is going to be applied.
In conclusion, the Analytical Method Validation in Pharmaceuticals is very important if drug developers are to come up with high quality drugs. Without this method, it might be a great risk to human health since important things such as potency of a drug will not be able to be determined. It might also be a challenge to ensure all impurities and unwanted materials are excluded from the drug. It is therefore a very crucial part of every drug development procedure that every drug manufacturing company ought to have in place.
