
The pharmaceutical industry operates under strict regulations to ensure the safety, efficacy, and quality of medicines. ISO (International Organization for Standardization) guidelines play a crucial role in maintaining these standards, providing a framework that helps pharmaceutical companies manage their operations efficiently while adhering to regulatory requirements. In this article, we’ll explore the key ISO guidelines relevant to the pharmaceutical industry and their significance in ensuring quality and compliance. 1. Introduction to ISO Guidelines ISO is an independent, non-governmental international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. In the pharmaceutical industry, ISO guidelines are integral in areas such as quality management, risk management, environmental management, and data integrity. These guidelines help pharmaceutical companies meet regulatory requirements and improve operational efficie...