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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Ingredient Supplier Audits – Free of Bias?
If you work for a pharmaceutical firm, let’s say that you are responsible for ensuring that your company’s excipient suppliers have the proper cGMP quality controls in operation. In past years, you might have relied on the responses that suppliers sent to a questionnaire, but FDA is raising the bar and now wants you to […]
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5 Critical Tips to Solve An FDA Warning Letter Crisis
Every year, FDA sends out hundreds of warning letters to drug and device companies for cGMP and quality system regulation violations. Some of the violations are for manufacturing violations and some are due to misbranding and mislabeling. Firms that respond effectively to an FDA warning letter are getting a step ahead of the game. Addressing […]
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Reminders About FDA Requirements for Qualifying Vendors
FDA Compliance News From the point of view of FDA, it is not required for a drug company to do a site audit of a supplier or vendor. According to 21 CFR 211.84, all of the lots of all components have to be tested before they can be used for compliance purposes with predetermined specifications. […]
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Three Simple FDA CAPA Tips to Assure Compliance
Latest FDA and cGMP Compliance News FDA investigators often focus on CAPA (corrective and preventive actions) procedures during a quality inspection because it is a good road map to ID existing problems at your company. Your firm’s CAPA documentation gives investigators and managers a way to go over and review problems. So, effective CAPA management […]
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