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FDA Issues Guidance on CMO Quality Accords

The FDA has issued long-awaited guidance on how drugmakers and their contract manufacturing partners can best use quality agreements to ensure safe and effective drugs. The guidance recommends companies establish formal quality agreements with contract manufacturers and testing labs, and that they build strong safeguards into the agreements. The guidance will be welcome news to FDA investigators, who now routinely review quality agreements during inspections but have lacked guidance on what a good agreement should contain. The guidance, at a mere 12 pages, is unlikely to resolve all issues. But it does offer the industry the agency's perspective on a number of key issues. . . .
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UK Lawmakers Urge Action to Address Ongoing Drug ShortagesUK Lawmakers Urge Action to Address Ongoing Drug Shortages

British lawmakers are calling for urgent action to address continuing shortages of brand and generic pharmaceuticals in the country. What does the group want? Brand drug shortages are less visible than they were several years ago, as a stronger pound has caused a decline in the export of drugs meant for the UK to other countries, a process known as parallel trade, according to the All-Party Pharmacy Group (APPG). . . .
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FDA Plans to Get Tough on Poor Data IntegrityFDA Plans to Get Tough on Poor Data Integrity

The FDA intends to step up its scrutiny of a company's data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data. . . .
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FDA Warns Compounding Pharmacy Quartet With cGMP Violations
Who is involved: The compounding pharmacies Oakdell Pharmacy and its subsidiary Home Intensive Care Pharmacy, RC Compounding Services and PharMEDium. What happened: The FDA cited a quartet of compounders for a wide swath of quality violations, igniting renewed criticism that the agency is "unjustified" in using a new law to enforce old violations. . . . keep reading
Chronic Lack of Quality Testing Leads to FDA Alert for Compounder
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. . . . keep reading
Fresenius Kabi Initiates Massive Recall Due to Glass Particles
German manufacturer Fresenius Kabi's U.S. subsidiary is recalling nearly 3 million vials of an injectable anti-seizure medication due to glass flakes in sample vials. . . . keep reading
FDA Warns Italian API Maker for Deleting Data, Poor GMP Training
Who is involved: Italian active pharmaceutical ingredient manufacturer Trifarma S.p.A. What happened: The FDA has slapped a warning on Trifarma for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. . . . keep reading
Persistent Particulates Result in Latest Hospira Recall
Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant. . . . keep reading
JCB Labs Gets Warning Letter for Adulterated Propofol
Compounding pharmacy JCB Laboratories has been hit with an FDA warning letter for failing to properly package and store vials of the powerful anesthetic Propoven. . . . keep reading
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