Analytic method development, transfer, and validation are the key components of any pharmaceutical development program. This technical summary will focus on development and validation activities as referred to drug products. Often considered routine, too little attention is spent on them with regards for their potential to contribute to overall Analytical method development time and cost-effectiveness.
These method-related exercises are interrelated. They are iterative, especially during early drug development stages. Parts of each method may occur concurrently or be refined at several phases of drug development. Changes encountered during drug development may require adjustments to existing analytic methods.
Importance Of Analytical Method Validation:
Method validation is an important element in the use of chemical analysis. However, awareness of its significance, why it should be done and when, and accurately what needs to be done, seems to be reduced amongst analytical chemists.
Much information related to method validation already exists in the literature, particularly related to particular methods, but more often than not, is underused. Some analysts view method validation as something that can only be done by helping with other laboratories and therefore, does not go about it.
In addition, analysts’ understanding of process validation is inhibited by the fact that several of the technical terms used in the processes for assessing methods vary in different sectors of analytical measurement, both in terms of their purpose and the way they are determined. Validation refers to a defined protocol, for the determination of a detailed analyte and range of concentrations in a special type of test material, used for a specified purpose.
In general, validation should indicate that the method performs adequately for the purpose during the range of analyte concentrations and analysis materials to which it is used. It follows that these features, commonly with a statement of any fitness-for-purpose criteria, should be thoroughly specified before any validation takes place.
Elements of Validation:
The validation of an analytic method shows the scientific soundness of the measurement or characterization. It needed to varying extents throughout the administrative submission process. The validation practice proves that an analytic method measures the correct substance, in the right amount, and the appropriate range for the proposed samples. It allows the analyst to get the behavior of the method and to verify the performance limits of the technique. Sources for information and approaches to method validation noted in the endnotes.
In order to work method validation, the laboratory should be following a written standard operating procedure (SOP) that describes the method of conducting method validation. The laboratory should be utilizing qualified and calibrated instrumentation with a corresponding operating SOP.
Topical formulation development is a type of cellular transport and can be examined during skin-permeation studies. The effect of the right formulation and delivery method in topical pharmaceuticals is critical.
The laboratory should be utilizing qualified and calibrated instrumentation by a corresponding operating SOP. There should be a well-developed and documented analysis method in place, and an approved protocol should be in place previous to the execution of any validation experiments.
The protocol is a program that describes which method production parameters will test, how the parameters will impose, and the acceptance criteria that will be applied. Lastly, samples of API or drug product, placebos, and evidence standards are needed to perform the validation experiments.