FDA REGULATED INDUSTRIES – VALIDATION CAPABILITIES OVERVIEW

Situation

Consumer health and safety can be put at risk if undetected problems occur during the production, storage or handling of food or pharmaceutical products. Manufacturers and government regulatory agencies have placed strict controls on the design, installation and operation of production facilities in these industries to protect the consumer.

The food and pharmaceutical industries in the USA must comply with the Current Good Manufacturing Practices (cGMPs) contained in the Code of Federal Regulations, Title 21, Food and Drugs (21CFR). The Food and Drug Administration (FDA) enforces these regulations.

Validation is one tool introduced in 21CFR that is used to assure that products are produced on a reliable and repeatable basis. Validation activities occur throughout the lifecycle of an engineering project in these industries.

Automation and information systems are a critical part of food and pharmaceutical manufacturers operations, and must be included in the validation process. TransAmerican Automation Inc. (TAI) has the capabilities to assist in this critical area. Our knowledge, experience and methodology make TAI a unique resource for these industries.

Background and Terminology

The FDA defines validation as “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications and quality attributes.” This concept applies to everything associated with making the product, including process equipment, personnel training, standard operating procedures, material handling, instrumentation, controls, and automation and information management systems (including PLCs, HMIs, DCSs, and computers). A process can only be validated once it is installed and tested in its final environment.

Manufacturers have formed various trade associations that have addressed “best practices” for validation efforts. One such organization, the Good Automated Manufacturing Process Forum (GAMP), has addressed the validation of automation and information systems in particular. In its Guide for Validation of Automated Systems in Pharmaceutical Manufacture, GAMP has expanded the concepts contained in the FDA‘s Guideline on General Principles of Process Validation. Its guide also defines the roles and responsibilities of the end user and the supplier of the automated system.