Is ISO considered GMP ?

Is ISO considered GMP?

When it comes to manufacturing and production, there are several regulatory standards that companies must adhere to. Two of the most well-known and widely implemented standards are ISO (International Organization for Standardization) and GMP (Good Manufacturing Practice). Both ISO and GMP aim to ensure the quality, safety, and reliability of products, but they have different focuses and objectives. In this article, we will explore whether ISO can be considered a part of GMP or if they are separate entities.

ISO: Setting International Standards

ISO is an international organization that develops and publishes standards for a wide range of industries, including manufacturing and healthcare. The organization is known for its high-quality standards, which are designed to promote consistency, efficiency, and safety.

ISO's standards are divided into two main categories: "process" standards and "product" standards. Process standards describe the steps and procedures that companies should take to achieve consistent results and ensure product quality. Product standards describe the requirements and specifications for specific products, such as medical devices or consumer goods.

GMP: Ensuring Quality and Consistency

GMP is a specific standard that is focused on ensuring quality and consistency in the manufacturing and healthcare industries. The standard was developed by the European Union and is now widely recognized and implemented by companies around the world.

GMP requires companies to establish and maintain a quality management system that meets specific requirements and objectives. The standard provides guidance on areas such as product development, manufacturing, and testing, and it promotes the development of key performance indicators (KPIs) that can be used to measure and improve product quality.

ISO and GMP: Different Focuses and Objectives

While ISO and GMP both aim to ensure the quality, safety, and reliability of products, they have different focuses and objectives. ISO is focused on developing and maintaining international standards for a wide range of industries, while GMP is focused specifically on ensuring quality and consistency in the manufacturing and healthcare industries.

ISO is a global organization that develops and publishes standards for a wide range of industries, while GMP is a specific standard that is focused on ensuring quality and consistency in the manufacturing and healthcare industries. Both standards are designed to promote consistency, efficiency, and safety, but they have different focuses and objectives.

Conclusion

In conclusion, while ISO and GMP both aim to ensure the quality, safety, and reliability of products, they have different focuses and objectives. ISO is a global organization that develops and publishes standards for a wide range of industries, while GMP is a specific standard that is focused on ensuring quality and consistency in the manufacturing and healthcare industries. Both standards are important regulatory frameworks that promote consistency, efficiency, and safety, but they serve different purposes and have different requirements. Therefore, it can be considered as GMP is a part of ISO.