The core of my background was built upon analytical development science for biotechnology companies including Celera and Genentech. It became routine to develop analytical assays to test products such as, proteins, monoclonal antibodies, recombinant protective antigen, DNA, RNA, etc. These tests were predominantly developed on state of the art techniques such as High Performance Liquid Chromatography (HPLC), Mass Spectroscopy (MS), DNA sequencers and so on.
Analytical methods used in the pharmaceutical and biotechnological industries are the critical means by which to ensure that drug products, biotherapeutics, and all other products manufactured by companies in this sector, meet acceptance criteria. Acceptance criteria are based on the type of product being analyzed and the test method being used. Analytical methods are developed to test the efficacy, purity, identity, potency and concentration of in-process samples and finished products.
Analytical method qualification is tightly associated with analytical method validation, just as Installation Qualification, Operational Qualification and Performance Qualification are with Instrument Validation. The term analytical method validation and qualification are practically interchangeable terms used within the industry. The purpose of analytical method validation is to confirm and document that the method works as intended. Irrespective of any prior validation or qualification work done for prospective methods historically, any time a method is transferred, installed, or created on a new, or existing system, it must be validated. These methods will require complete validation packages to be created and executed.
Methods, especially those that that rely on chemistry or other environmentally sensitive mediums, are not necessarily reliably reproduced from system to system, nor environment to environment. Factors such as relative humidity, lab temperature, reagent manufacturer, column manufacturer, and lot to lot variability can greatly affect the efficacy of the method. This is why a complete validation package is required, so that documented proof is created confirming that the method works as designed.
To validate an analytical method, International Conference for Harmonization (ICH) guidelines must be followed. The analytical method will be assessed to determine which ICH method validation parameters are applicable. The ICH method validation parameters are as follows: specificity, linearity, range, accuracy, precision (repeatability & intermediate precision), detection limit, quantitation limit, robustness and system suitability testing are used to demonstrate and document that a method works at the site they are located, on the system provided, and for the products being tested.
A complete validation package will be created for each analytical method that will include the following: applicable validation parameters, test cases designed for each characteristic, the acceptance criteria, and any other parameters or variables that are considered within scope to complete testing, as well as the data analysis, and validation report.