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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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Compounders Says FDA Guidance on Interim GMPs is Subjective, UnclearCompounders Says FDA Guidance on Interim GMPs is Subjective, Unclear

Compounding pharmacies are asking the FDA to overhaul its guidance for interim good manufacturing practices, contending the recommendations for such things as the cleanliness of air filters and presence of particulates are unclear and subjective. . . .
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Brazil Guidance on Drug Tracking Calls for Real Time ReportingBrazil Guidance on Drug Tracking Calls for Real Time Reporting

Drugmakers operating in Brazil must report all supply chain movements to regulatory authorities in real time, according a new guidance on the country’s drug tracking and tracing system. But an attorney familiar with the topic says the system doesn’t address concerns of biosimilars. . . .
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BI Continues to Be Plagued by Quality Problems at Ben Venue
Who is involved: Shuttered Boehringer Ingelheim subsidiary Ben Venue. What happened: Ben Venue continues to create quality headaches for German manufacturer BI with the recall of a chemotherapy drug due to a container defect. . . . keep reading
Wockhardt Recalls More Than 11,600 Bottles of Generic Toprol-XL
Beleaguered Indian generics maker Wockhardt has initiated a voluntary Class II recall of 11,661 bottles of metoprolol succinate, a generic version of AstraZeneca’s blood pressure drug Toprol-XL. . . . keep reading
FDA Warns Compounders for Poor Quality and Unapproved Drugs
Who is involved: Compounding pharmacies Zion Rx Formulation Services and The Compounding Shop. What happened: The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won't let up on larger facilities. . . . keep reading
Teva Recalling ‘Superpotent’ Drug for Parkinson’s Disease
Teva Pharmaceutical is pulling 3,881 bottles of a generic combination drug to treat Parkinson's disease because the tablets are potentially "superpotent," marking another recall for the company this year. . . . keep reading
Sun Conducts Massive Recall Due to Poor Quality of APIs
Who is involved: Indian drugmaker Sun Pharma. What happened: Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn't manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker. . . . keep reading
Dr. Reddy’s Discloses Accusations of Improper Packaging
Indian generics maker Dr. Reddy's Laboratories is under investigation for allegedly selling prescription drugs without sufficient child-resistant packaging, the company revealed. . . . keep reading
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