The fragmented nature of the modern manufacturing sector necessitates focusing less on technology and more on integration, according to an industry expert. Source: Drug GMP Report

A contract manufacturer is being hit with a warning letter over a slew of GMP and labeling violations. Source: Drug GMP Report

There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause…

The FDA expects drugmakers to have quality agreements with their suppliers, but how those agreements are crafted says a lot about a company’s internal auditing program. Source: Drug GMP Report

The European Medicines Agency and the European Commission today published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. Source: Drug GMP Report

The FDA slammed Denmark’s Novo Nordisk for numerous GMP issues in a 13-item Form 483 for inadequate controls for sterility, environmental monitoring, labeling and written procedures. Source: Drug GMP Report

Robert Califf was sworn in as the new commissioner of the FDA Feb. 25 after the Senate confirmed him on Feb. 24 in a roll call vote of 89 to…

A new report pushes states to agree on common standards for traditional compounding operations and recommends a series of best practices for all to follow. Source: Drug GMP Report

Heparin is back in the news, after France’s National Agency for Medicines and Health Products Safety issued a GMP noncompliance statement to China’s Dongying Tiandong Pharmaceutical, which manufactures the active…

The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Source: Drug…