Validation Plan or Protocol

A formal protocol, in addition to describing the validation requirements and procedures, will specify the person, often referred to as the Principal Investigator or Principal Scientist, who has the responsibility for the overall conduct of the study. In many cases the protocol will be relatively brief and will simply refer to existing laboratory SOPs or documents to describe the procedures that need to be followed. If detailed descriptions of validation requirements and procedures are not available, the protocol can serve as the primary 

The Problem (vahdation requirements in this case) should be clearly defined with highly specific definitions for the scope and objectives of the work to be undertaken. If part of a larger program, the protocol may include an overview of all other activities relating to the work, e.g. cross validation activities at another laboratory, but more likely a vahdation protocol will be focused on the analytical portion of the study and the procedures to be conducted in a particular laboratory. 

The Model includes the hypotheses to be tested (vahdation parameters), as well as the general data requirements including the precision and accuracy targets that must be established for each experiment. 

The Specification of Samples includes details relating to the types and numbers of samples to be analyzed. In the context of a validation this will essentially be a description of the QCs and how they will be used to validate specific parameters. A reference to the SOPs that describe the procedures and documentation requirements for the preparation and storage of QCs should also be provided. If these do not exist, they should be created or included in the validation protocol. 

A detailed Specification of the Methodology is a critical component of the protocol so that there are no ambiguities with respect to how the assay should be performed. In addition to the analytical method, any other procedures that are required but not described in the method should described in detail in the protocol, or references to the prevailing SOPs should be provided. 

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A validation plan or protocol (Section 10.3.1) that specifies the experiments to be run on each day should be prepared prior to validation sample analysis. This document should specify how the validation should be conducted and, for validations that are conducted over multiple days, the plan should specify what experiments should be run on each day. Prior to the initiation of work, the protocol should be reviewed. Any questions or discrepancies should be resolved and, if necessary, an amendment should be prepared to resolve these issues. 

Any significant deviations from the prevailing SOPs, validation plan or protocol must be noted in the report with a statement that addresses the impact, if any, the deviation may have had on the study or results. Significant deviations or an excessive number of deviations may require repeating some of the validation runs or repeating the entire validation in accordance with the specific procedures described in the analytical method. 

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