White Paper

Life Sciences

Management Summary

The Life Sciences industry requires a large amount of documentation to verify that the products it claims to make are actually those that it does make. Before a product can be sold, the plant that manufactures that product must be validated. The validation process consists of documentation and tests. The documentation includes all aspects of drug production including discovery, development, clinical trials, plant design, plant construction, automation system design and automation system construction.

This document provides an overview of validation and the main documentation pertaining to automation systems.

Abstract

The main regulatory body in the Life Sciences industry is the Food and Drug Administration (FDA) of the United States. The applicable regulations for drugs are codified in Title 21 of the US Code of Federal Regulations (CFR), also known as 21 CFR. The document of particular interest in automation systems is 21 CFR part 11, Electronic Records and Electronic Signatures. Other documents of interest include: 21 CFR part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs; 21 CFR part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.

In Europe, the regulatory body is the European Agency for the Evaluation of Medicinal Products (EMEA). Other countries, such as Japan and China, also have their own regulatory bodies. However, since the FDA has the most comprehensive and transparent regulatory system in the world it is generally used as the benchmark for drug manufacture. In any case, any drug for later sale to the US (and the US is by far the largest market for drugs) must be manufactured in accordance with FDA requirements, so for most manufacturers it makes sense to manufacture according to FDA regulations and add local regulatory agency requirements if necessary.