From drug safety testing to AI-enabled medical devices, ethical and regulatory standards are the backbone of trustworthy science. Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and ...

The US Food and Drug Administration (FDA) posted two warning letters on Monday that flagged a total of nine violations of good manufacturing practice (GMP) at California-based Total Thermal Imaging ...

Increased regulatory focus on data integrity violations in GxP inspections opens opportunities for pharma companies to invest in staff training and compliance strategies related to document management ...

The Drug Controller General of India (DCGI) has ordered companies to self-assess their compliance with good manufacturing and laboratory practices (GMPs/GLPs). DCGI is demanding manufacturers carry ...

Market opportunities include enhancing medical device quality through robust process validation training, aligning with regulatory and QMS needs, and integrating GAMPv for improved data integrity.