How to Handle An FDA Warning Letter
Did your company receive an FDA warning letter, possibly including cGMP violations? If so, there are vital steps you can take to reduce the effects of the warning letter. The warning letter will be issued if there is a deficiency or violation in your pharmaceutical or medical device operations. These letters tell you that your […]
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FDA Talks About Importance of Data Integrity And Data Governance Plans
At the recent PDA/FDA Joint Regulatory Conference, CDER’s Quallyna Porte talked about how FDA is focusing on data integrity and data governance plans in 2022 cGMP audits. Porte noted that pharmaceutical companies need a solid data governance plan that is as well established as possible. This ensures across the plant that pharma data is handled […]
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FDA Stresses The Importance Of Engaging With The Agency Early and Formally
In February 2022, FDA organized a public oncologic drugs advisory committee or ODAC meeting to review a sintilimab application that was based on the ORIENT-11 clinical trial done in China only. Instead of following the regular method of reviewing the risks and benefits of one drug, the FDA committee only voted on one question. It […]
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Is Your cGMP Quality System Ready For An FDA Inspection?
At this year’s PDA/FDA conference, FDA’s Director for the Division of International Drug Quality Carmelo Rosa offered the agency’s regulatory point of view on pharmaceutical quality systems. She also detailed some of the latest FDA audit trends of drug facilities. Rosa noted as she reviewed the most frequent FDA warning letter observations for drug manufacturers […]
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Most Common FDA 483 Inspection Observations in 2020
By reviewing the most common FDA 483 inspection observations, it’s possible for pharmaceutical companies to get a better grasp of how to organize their facility procedures and personnel. We recently came across FDA data that revealed some of the most common 483 observations for 2020: Absence Of Written Procedures In 2020, FDA failed to find […]
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What FDA Guidance Documents Can Drugmakers Expect in 2022?
Every year, FDA’s CDER and CBER plan the priorities they want to deal with in industry guidance and offer help to the industry on particular regulations that may be hard to understand. This has been the case in recent years with CAR-T treatments and gene therapies. But FDA also has offered new guidance in recent […]
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Shared Qualification Audits Are Best Practice For Phase 1 Drugs
At the end of 2021, FDA released an update to its Resiliency Roadmap for FDA Inspectional Oversight. This shared FDA’s success in dealing with COVID-19 on inspections both in the US and overseas and how it is using remote interactive audits and evaluations to support its work. During the COVID era, FDA has shown it […]
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How To Avoid FDA 483 in 2022 and Beyond!
cGMP regulations have not changed a lot in the past few years, but FDA expects you to be in full compliance with cGMPs more than ever. With Turbo EIR and other computerized systems, FDA inspectors have time to focus on pharmaceutical and medical device industry trends and focus on more risk-based criteria. Pharmaceutical industry insiders […]
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Top 10 Reasons Deviation Investigation Systems Fail
For many drug companies, we find that manufacturing is a bit of a crapshoot. There is not a great deal of basis for confidence that the proper equipment, components, materials, people and records are going to be in the proper place to start manufacturing. And once that manufacturing starts, you might need a crystal […]
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FDA cGMP Compliance News and Tips by Expertbriefings.com
Below are the original Expertbriefings.com cGMP and FDA-related stories for 2014. Be sure to review our new FDA Digest e-newsletter – learn FDA news and compliance tips, and also read our exclusive 483 and warning letter reports. FDA cGMP Compliance News and Tips March 4 – Will OTC Lipitor Win FDA Approval? Feb. 26 – […]
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