And the #1 cGMP 483 Observation for 2012 Is….
More Exclusive FDA cGMP Compliance News April 17, 2013 At a Georgia GMP meeting in March 2013, Monica Caphart, Chief of Medical Products and Tobacco Program Operations at FDA’s Office of Regulatory Affairs, provided some 2012 statistics on the top cGMP 483 citations. She compiled this information using FDA’s Turbo Establishment Inspection Report: Poor quality […]
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cGMP Consultant Paid $1000 a Day For Assembling Binders? Whispers Around the Pharmaceutical Water Cooler
More Exclusive FDA cGMP Compliance News April 16, 2013 Last month, we wrote a controversial cGMP story that posed the following question: Is GSK pressure on FDA influencing Hospira 483 failures? According to our anonymous source in the industry, GSK has used its influence on FDA to put regulatory pressure on Hospira to drop the […]
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Why You Need a Strong Relationship with Your Contract Manufacturing Organization (CMO)
More Exclusive FDA cGMP Compliance News April 16, 2013 According to Kathleen Culver, an FDA cGMP investigator from the Cincinnati office, it is very important to have a strong, positive relationship with your CMO, or contract manufacturing organization. She recently related to us a story where a poor relationship with a CMO caused major problems […]
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Latest FDA cGMP Inspection Trends Highlighted at Recent Conference
More Exclusive FDA cGMP Compliance News April 16, 2013 At a Georgia GMP meeting in March 2013, Monica Caphart, Chief of Medical Products and Tobacco Program Operations at FDA’s Office of Regulatory Affairs, gave attendees an update on the most recent cGMP inspection trends at the agency. Some of the highlights we heard included the […]
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Limitations of 5 Whys in CAPA and Root Cause Analysis
More Exclusive FDA cGMP Compliance News April 15, 2013 FDA’s Quality System Regulation, and also the Quality Systems Approach to cGMP Regulations require CAPA (21 CFR 820.100) with root cause analysis as a reactive tool for quality system improvement to make sure such problems do not recur. Many in the pharmaceutical industry know the […]
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Stability Testing a Common Problem in FDA Warning Letters
More FDA, cGMP Compliance News Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 15, 2013 Stability testing of drug products is required by 21 CFR 211.166Â of the cGMP guidelines. Stability is how much the product remains in established parameters at the established conditions and needed shelf life. Problems […]
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21 CFR 211.194 – Tips for Laboratory Records Compliance for QC Laboratories
More FDA, cGMP Compliance News Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 15, 2013 There are major implications for the pharmaceutical laboratory regarding FDA’s requirements for risk assessment and management all through the product life cycle. The onus is now on the pharmaceutical industry. You need to address […]
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21 CFR 820.198 – Implementing Risk-Based Management in Handling Complaints
More Exclusive FDA cGMP Compliance News Complaint Handling – 21 CFR 820.198 A strong complaint-handling process, according to 21 CFR 820.198, is a system of management that guarantees the highest possible level of patient safety. It also secures the highest possible investment return and it reduces product liability lawsuits to the minimum. A good complaint-handling system […]
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FDA Social Media Guidance Coming!
More Exclusive cGMP FDA Compliance News For the past few years, drugmakers have grappled with the Internet and how to promote their medicines to an increasingly interactive public. Although the FDA held a widely attended meeting in 2009 and indicated that a draft guidance would soon be forthcoming, the agency has yet to do issue […]
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21 CFR 820.198 – Avoiding Pitfalls in Your Complaint-Handling Process
More Exclusive FDA cGMP Compliance News Complaint Handling 21 CFR 820 A complaint is defined in 21 CFR 820 and the Safe Medical Devices Act as an report of dissatisfaction with device quality or performance, or a defect after a product was sent into distribution. A complaint, therefore, is a great post market surveillance tool. […]
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