Is compliance with the FDA regulations the same as conforming to ICH guidelines or ISO standards?
Compliance with FDA regulations goes a long way toward preparing your organization to meet ICH guidelines and ISO standards, but they are not interchangeable. Without adequate CGMP compliance, for example, drug products are considered adulterated. FDA CGMP guidance documents, on the other hand, are not requirements. They represent current thinking on acceptable practices. Likewise, ICH guidelines and ISO standards are not requirements, but guidelines developed by expert working groups made up of industry and governmental representatives from member countries around the world. While there is an overall trend toward harmonizing standards and regulations governing pharmaceutical products, voluntary guidelines have a customer focus that is outside the regulatory mandate to protect the public health.
