The World Health Organization (WHO) is seeking comments by February 28 on a draft policy on tracking and tracing drugs through the supply chain that would push globally for unit-level serial numbers.
Source: Drug GMP Report
Category Archives: Drug GMP Report
The FDA hit drugmakers in China, South Korea, India and Germany for numerous GMP and other violations observed during agency inspections.
Source: Drug GMP Report
The FDA issued warning letters to drug manufacturing facilities in China and Germany for lax testing, recordkeeping and other failures.
Source: Drug GMP Report
A blockchain-based drug tracking network is capable of meeting future supply chain regulatory requirements, according to pharma companies that took part in a pilot program run by the FDA.
Source: Drug GMP Report
Former FDA Commissioner Scott Gottlieb warned of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of starting materials. The agency reported the first coronavirus-related shortage on February 27 but did not name the product.
Source: Drug GMP Report
The FDA flagged facilities in the U.S., China and India for deficiencies uncovered during agency inspections.
Source: Drug GMP Report
The FDA sent recent warning letters to drug facilities the U.S., Canada, Australia, China and the Caribbean for serious GMP failures.
Source: Drug GMP Report
Post-inspection Official Action Indicated (OAI) classifications by CDER and CBER have dropped sharply in recent years, according to the latest data from the FDA’s Inspection Classification Database.
Source: Drug GMP Report
The World Health Organization (WHO) and international regulators including the FDA have launched a pilot program for joint GMP inspections of sterile drug manufacturers.
Source: Drug GMP Report
A federal judge has ruled that the FDA can no longer regulate barium sulfate as a drug.
Source: Drug GMP Report