Stimuli to the Revision Process

In this Stimuli article, the USP Validation and Verification Expert Panel discusses how the modern concept of a lifecycle model, which is based on process validation and described in ICH guidelines Q8, Q9, and Q10, can be applied to analytical procedures. The Expert Panel proposes that the traditional approaches to validation, transfer, and verification should be integrated into the analytical procedure lifecycle process rather than being viewed as separate entities. As a starting point or “predefined objective” according to ICH Q8, the requirements for a measurement of a critical quality attribute are established in the Analytical Target Profile. In alignment with process validation, three stages are proposed: Procedure Design (development and understanding), Procedure Performance Qualification, and Continued Procedure Performance Verification. INTRODUCTION Any analytical procedure must be shown to be fit for its intended purpose before use. [NOTE—The term analytical procedure used in this Stimuli article is interchangeable with the term method commonly used in industry and includes steps such as sample preparation, analytical technique, calibration, and definition of the reportable result.] The usual process of demonstrating this suitability in food and drug analytical laboratories takes place by way of a documented validation study and, if required, a verification or transfer process to demonstrate the procedure performs appropriately in the laboratory in which it will be used. The United States Pharmacopeial Convention (USP) has been a strong advocate of this process. General chapter Validation of Compendial Procedures 1225 , which was first published in USP XXI (1989), served as the foundation for the development of the ICH Q2 Guidance on Validation of Analytical Procedures (1). More recently, USP has further led on this topic with the publication of general chapters Verification of Compendial Procedures 1226 and Transfer of Analytical Procedures