Archive for March 2016
How Many Essential Elements Are in World-Class Quality Agreements? Try 24
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
Read MoreDistributor Faces Charges Over Sale of Alleged Counterfeit Drugs
Federal efforts to protect the drug supply chain continue to bear fruit, with the FDA’s Office of Criminal Investigations announcing criminal charges for another counterfeit operation. Source: Drug GMP Report
Read MoreAnalysis: State Rules for Compounding Vary Widely
A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations. Source: Drug GMP Report
Read MoreFDA Continues Nationwide Inspections of Compounding Pharmacies
The FDA is continuing its nationwide effort to single out compounding facilities that don’t conform to GMP regulations, and it blasted two pharmacies in Florida in recent warning letters. Source: Drug GMP Report
Read MoreSystemic Data Manipulation Uncovered at India’s Ipca Labs
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 GMP Report
Read MoreFrance Dings Chinese Drugmaker for GMP Deficiencies
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 ingredients of Lovenox and Heparin. Source: Drug GMP Report
Read MorePew Report Pushes States to Harmonize Compounding Standards
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
Read MoreSenate Confirms Califf for FDA Top Job
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 4. Source: Drug GMP Report
Read MorePentax Issues Revised Reprocessing Instructions for Duodenoscopes
The FDA has signed off on reprocessing instructions for Pentax’s ED-3490TK video duodenoscope that aim to prevent future of infections related to drug-resistant bacteria. Source: The GMP Letter
Read MoreExpert: ISO 13485 Could Cause Confusion With FDA’s Quality System Regulation
Changes in the new ISO 13485 may conflict with many of the requirements in FDA’s quality system regulation. Source: The GMP Letter
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