FDA Wants More Regulatory Authority To Regulate Drug Compounding
Latest cGMP and FDA Compliance News The current FDA commissioner, Margaret Hamburg, MD, told a congressional panel last week that current FDA law and regulations are not well suited to the regulation of large pharmacies that conduct drug compounding. The congressional panel is conducting an investigation into the fungal meningitis outbreak that killed dozens of […]
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The Risks of an FDA Import Alert
Updated Daily – Read our latest FDA, cGMP Compliance News If your pharmaceutical company is ever subjected to an import alert, the costs to your firm can be huge. You can lose millions of dollars, waste time and also affect the reputation of your company. How FDA Uses Import Alerts An import alert is used […]
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5 Laboratory Calibration Tips – Stay Ahead of the cGMP FDA Inspector
Updated Daily – Read our latest FDA, cGMP Compliance News Each year, research and commercial laboratories anticipate FDA’s annual audit of their compliance to cGMP and other regulatory guidelines. FDA regulations for laboratories are based on ISO 17025 standards. These focus on competency and consistency in your laboratory methodology. For firms that do laboratory research, […]
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FDA Guidance on Quality Agreements for CMOs Much Needed
Updated Daily – Read our latest FDA, cGMP Compliance News Guidance that has long been sought on quality agreements for CMOs, or contract manufacturing organizations, is expected to be released in 2013. Quality agreements for contract manufacturing organizations are very important to FDA, because each organization is unique. Companies that do not have quality agreements […]
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5 Crucial Tips to Deal With an FDA Warning Letter
Updated Daily – Read our latest FDA, cGMP Compliance News April 17, 2013 Every year, FDA hands out several hundred warning letters to pharmaceutical and medical device firms for cGMP guideline violations. Companies that respond effectively to the warning letter can get back in the good graces of FDA and develop quality control processes that […]
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Perfect OOS Results Will Make FDA Investigators Suspicious
More Exclusive FDA cGMP Compliance News April 17, 2013 In one of our recent FDA inspection Webinars, we heard some more interesting tips about what FDA cGMP investigators are looking for during an inspection: Marketed drug products that do not meet the specifications of the US Pharmacopeia. Many FDA investigators have a laboratory background, so […]
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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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