FDA Data Integrity Guidance: A Comprehensive Guide

In recent years, data integrity has become increasingly important in the life sciences industry. The US Food and Drug Administration (FDA) has been ramping up its efforts to ensure that pharmaceutical companies comply with regulations pertaining to the quality and accuracy of their data. This has led to the release of a number of guidance […]

Contemporaneous Definition In Pharma: What You Need To Know

The pharmaceutical industry is constantly evolving, and keeping up with the latest terminology can be challenging. One term that has been gaining prominence in recent years is “contemporaneous definition.” But what exactly does this mean in the context of pharma? In this article, we will explore the meaning of contemporaneous definition, its importance for regulatory […]

A Quality Systems Approach To Pharmaceutical CGMP Regulations: What You Need To Know

Pharmaceutical manufacturing is a complex and highly regulated industry with strict compliance requirements to ensure that products are of high quality, safe, and effective. One of the main regulations governing pharmaceutical operations is the Current Good Manufacturing Practices (CGMP) issued by the U.S Food and Drug Administration (FDA). To comply with CGMP standards, manufacturers must […]

Good Documentation Practices For FDA Compliance: A Comprehensive Guide

Maintaining good documentation practices is an essential aspect of achieving regulatory compliance, especially for companies operating in highly regulated industries such as pharmaceuticals and medical devices. The Food and Drug Administration (FDA) requires manufacturers to maintain complete, accurate, and accessible documentation throughout the product life cycle. This can be a tall order without a robust […]