Validation Program Overview

Qualification of process equipment. Define test functions and acceptance criteria for major equipment. A comprehensive list identifying the protocols required shall be finalized, or alternatively, shall be provided by the validation program overview in Step 9. 

Product development laboratories Utilities description Validation program overview... 

Recent overviews (2), examples (3), and our own experimental efforts (4,5) raised concerns about the reproducibility of a proportion of published data inferring to novel potential targets for a given disease, further highlighting the need for robust target validation programs in the pharmaceutical industry setting. 

On satisfactory completion of the computer system qualifications, with PQ conducted in conjunction with a successful process validation, a final report must be prepared by the pharmaceutical manufacturer s validation team. This is normally referred to as the validation report. The objective of the report is to give an overview of the results of the execution of the validation program for the computerized operation and to draw a conclusion as to the suitability of the computerized operation for pharmaceutical manufacturing. This may be unconditional use or there may be restrictions. In the latter case the proposed remedial ac-tion(s) must be approved and, as applicable, considered under change control. A schedule to complete any outstanding actions must be documented and progress formally reported. 

Tietge, J.E., Mount, D.R. and Gulley, D.D. (1994) The Gas Research Institute freshwater salinity toxicity relationship model and computer program overview, validation and application, Topical Report, Gas Research Institute, Chicago, IL, USA. 

The overall project itself requires formally structured planning and control in addition to the validation plans for the computerized operation. To provide this, a project and quality plan from the pharmaceutical manufacturer (or its nominated main contractor) is normally developed as a separate and complimentary document and needs to overview all activities, resources, standards, and procedures required for the project. The plan should define project-execution procedures, quality management procedures, engineering standards, project program, and project organization (with authorities and reporting responsibilities), and reference the project validation plan. There are instances in which the project and quality plan and the project validation plan can be combined into one document. 

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. 

This paper provides an overview of the monumental experimental program to provide data to validate models of radionuclide behaviour under accident conditions. There is an enormous volume of literature concerning this ongoing program. 

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