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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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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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PhRMA Calls for Restraint in FDA's New Import Destruction RulePhRMA Calls for Restraint in FDA's New Import Destruction Rule

The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn't protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA. . . .
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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
Baxter Recalls IV Solutions Due to Particles
Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates. . . . keep reading
Actavis Recalls Liquid Antibiotic in New Zealand
Actavis initiated a consumer-level recall of its amoxicillin powder for oral suspension in New Zealand after pharmacists found glass particles in two bottles of the liquid antibiotic. . . . keep reading
Sun Pharma Recalls More Than 40,000 Bottles of Effexor XR Generic Over Stability Issues
Who is involved: Indian generics maker Sun Pharma. What happened: Sun Pharma is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. . . . keep reading
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