What’s the difference between GMP and ISO?

The international organisation for standardisation (ISO), is a voluntary body that develops internationally recognised guidelines for best practice within business. GMP (Good manufacturing practices) are the recommended manufacturing practices for the sale of food, drug products, and active pharmaceutical products to conform to guidelines recommended by agencies that control the authorization and licensing. These guidelines provide the minimum requirements that a manufacturer must meet to ensure any products coming to the market are of high quality and cause no risk to the consumer.

Therefore, while both ISO and GMP focus on quality assurance, there are differences between them. ISO is designed to be business-focused, and yet generic, in order to fit into multiple industries and company requirements. The different standards support effective management of quality to an international level of best practice. The advantage of ISO is in the flexibility. ISO specifically explains what is needed to be achieved, while allowing each organisation the freedom to determine and justify how to achieve those requirements. In contrast, GMP is focused on specific industries and detailing what must be done to ensure safety and efficacy.

GMP can be viewed as the minimum standard and not the ultimate goal. Therefore, businesses should aspire not only to meet these requirements but to exceed them, which can be achieved through ISO 22716 and the process of continual improvement. An organisation can demonstrate compliance with GMP through implementing ISO 22716.