Change Control – Continuous Quality Improvement In FDA And ISO Environments

By Brian Curran

Globalization of the marketplace has greatly intensified competition. It has increased the pressure on manufacturers to develop innovative, high-quality products faster and at a lower cost. To stay competitive, manufacturers must be quick to meet customer demands and even quicker in adapting to changing market conditions.

The situation could not be more acute than in the FDA and ISO environments, where manufacturers must contend not only with cutthroat competition and a dynamic market, but also stringent regulatory requirements. Consider the fiercely competitive pharmaceutical industry. Only one of every 10,000 potential medicines investigated by American research-based pharmaceutical companies makes it through the rigorous FDA approval process, according to the Pharmaceutical Research and Manufacturers of America. It takes about 15 years at a cost of more than $1.1 billion before a new medicine is approved.

The road toward product development — and FDA approval or ISO certification — is clearly long, arduous, and costly. After a product is launched in the market, the manufacturer must continue to comply with regulatory requirements to stay in business. Regulations exist to ensure the safety and reliability of products. In this context, any change that affects the “purity” and effectiveness of the approved product is critical.

The fact that change is inevitable makes control a critical factor, especially in FDA and ISO-environments, where inappropriate or “uncontrolled” changes could affect the safety and reliability of products and directly impact public health and safety. This paper explains the definition of change, regulatory requirements, as well as the elements and challenges of change control.