Pharmaceutical Validation Documentation

The FDA's May 1987 definition of validation,contained in the General Principles of Validation, is still considered the gospel of computer control systems. According to this guideline validation involves "establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes."
The FDA demands that biotech and pharmaceutical manufacturers prove that processes will consistently do what they are proposed to do. This includes the proper operation of computer hardware and software. Although the FDA doesn't define the type or format of documentation required to validate each system, certain formats are accepted and expected.
A Validation Plan, sometimes called a Master Plan, is a clear and concise explanation of management philosophies and expectations concerning the validation programs. Specifically, it will outline responsibilities for each phase of the system design and the implementation process.
Protocols are written records clearly defining the objectives and methods that will be used for the validation programs. An important part of the protocol is the description of the testing method including who will test the system, how they will test it and what data is to be collected and reported.
Computerized system protocols often include the three distinct stages as described in PMA reports: Installation Qualification (IQ), Operational Qualification (OQ),and Performance Qualification (PQ).
Protocol Changes are documented requirements specifying who and how changes to parameters, thresholds, and acceptance criteria are made after approval. It is not impossible tomake changes after or during testing, but these changes must be properly implemented and approved to be validatable.
Specifications are written to clearly and completely describe what a system will do. These are rather lengthy descriptions of every hardware component (valve, motor, thermocouple, etc.— there can be thousands), how it communicates with the controller, and what each step in the automated sequence will accomplish. It will include all measurable and meaningful operating parameters. This document is reviewed and approved by responsible personnel at the manufacturer's facility before implementation.
The Factory Acceptance Test requires a document describing specific inputs that must be activated with the resultant outputs they produce for every step of the automated sequence. This document allows for management sign off or confirmation that each part of the entire control system has been tested.