The International Organization for Standardization is a voluntary body that develops best-practice guidelines for businesses. The Food and Drug Administration's good manufacturing practice program regulates manufacturing in specific industries. ISO and GMP standards both focus on quality assurance, but there are some differences between the two.
Quality Assurance Aims
ISO standards help companies learn how to apply quality, reliability and safety criteria. They streamline processes and procedures to increase productivity and minimize inefficiency. The FDA uses GMP to regulate certain industries to protect consumers from harm. It requires companies to meet specific standards for manufacturing processes, procedures and facilities.
As of May 2014, there are 19,500 ISO standards. Some focus on specific industry needs, such as food safety management or manufacturing engineering. Others have a more general business focus, such as quality management or social responsibility. The FDA's GMP standards apply only to the drugs, medical devices, blood, and certain food and cosmetics industries.
Voluntary Vs. Mandatory
Companies can typically choose whether to implement ISO standards. In some cases, however, governments adopt standards into legislation. For example, Australia has made compliance with ISO 8124.1:2002 mandatory for companies that manufacture or sell certain types of toys to young children. Compliance with GMP is always mandatory; its regulations have the force of law. If a company fails to meet its obligations, the FDA can recall and seize products or shut down facilities. If the Department of Justice becomes involved, companies may have to pay fines or face criminal liability prosecution.
The ISO comprises 162 standards organizations -- each of these organizations is an ISO member, representing the interests of a specific country. GMP is also recognized internationally; however, this is a domestic rather than international system. Other countries use their own versions of good manufacturing practice, but they must meet FDA GMP standards to import products into the U.S.
- ISO: Standards
- International Society for Pharmaceutical Engineering: What is GMP
- Australian Competition and Consumer Commission: Toys for Children up to and Including 36 Months of Age
- Hunton & Williams LLP: More Scrutiny for cGMP Violations
- ISO: FAQs -- Standards
- ISO: ISO Members
- Food and Drug Administration: Importation of Drugs Outline