The Clock Is Ticking – Responding to FDA 483 in 15 Days
Updated Daily – Read our latest FDA, cGMP Compliance News When you respond to an FDA 483 for cGMP violations, you need to be sure that your response letter addresses each specific violation. Many companies will address the individual FDA complaints, but they never actually get down to a real solution to the problems. […]
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GMP Problems Result in 300 Jobs Chopped At Novartis Plant
Updated Daily – Read our latest FDA, cGMP Compliance News One way to deal with a 483 or warning letter for cGMP violations is to just chop operations. And that is exactly what Novartis is doing in Lincoln, Nebraska. About 18 months after Novartis admitted that it had major cGMP guideline problems at this […]
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Effective Project Management for Developing Medical Devices
Updated Daily – Read our latest FDA, cGMP Compliance News If your organization is developing a new medical device (21 CFR Part 820), you need to have effective project management. Below are some of the most important tips in our experience to ensure success of your medical device: #1 Always Under Promise and Overdeliver! Having […]
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4 Best Practices for Strong cGMP Plant Design
Updated Daily – Read our latest FDA, cGMP Compliance News Below are some of the most important aspects of designing a cGMP-compliant drug production facility. #1 Appropriate cGMP Layout A good cGMP plant layout has separate areas for the most critical functions of the facility. This is very important for any drug products that have […]
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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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