GxP Posts - Compliance & Discussion

If you want to know whether a manufacturing site is GMP-compliant, don’t start with the lab— start with the batch records. These...

In today’s regulated environment, a vendor audit  is more than just a compliance obligation—it's a critical part of protecting your...

Good Clinical Practice (GCP)  is the gold standard for conducting ethical and high-quality clinical research. In the era of decentralized...

In today's fast-paced world of clinical research, maintaining Good Practice (GxP) compliance is essential for ensuring the safety,...

Data integrity is no longer just a compliance checkbox—it’s a top priority  for regulators worldwide. The FDA, EMA, MHRA, and WHO  have...

Date: March 9, 2025 Welcome to our March deep dive into FDA inspections and the radiopharmaceutical landscape! As these radioactive drugs...

Navigating Clinical Research Regulations: GCP Auditing Insights Clinical research is a critical component of advancing medical treatments...

In the pharmaceutical industry, adhering to Good Manufacturing Practice (GMP) GMP standards is essential for ensuring product quality and...

When it comes to ensuring compliance with GxP standards in industries like pharmaceuticals and clinical research, having the right...