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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No Need to Validate the Software in Design and Development? Wrong!
Recent FDA Compliance News You might be surprised how many professionals think that they don’t need to validate the software/automated test equipment in their design and development processes. This is not correct! If you are utilizing a software tool or any kind of automated test to do design or design verification OR validation, then the […]
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Most Common FDA 483 Violations for Medical Devices
Recent FDA Compliance News According to recent FDA CDRH information, the most common 483 violations in the medical device industry are the following: Corrective and preventive action procedures (CAPA) – CFR 820.100(a) Complaint procedures -Â CFR 820.198(a) Corrective and preventive action documentation – 820.100(b) Process validation – 820.75(a) Written MDR procedures – 803.17 Below are […]
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New FDA Warning Letters Point Out CAPA Flaws
Latest FDA and cGMP Compliance News FDA is focusing its cGMP and Quality System Regulation efforts on the midwest and abroad in a new wave of medical device warning letters. One of the companies that was hit this summer was Enraf-Nonius BV, which is a medical device company in the Netherlands, but doing business in […]
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FDA cGMP Inspections in US Getting More Intense
Latest FDA and cGMP Compliance News US FDA cGMP audits continue to be getting tougher, partially because the priorities of FDA and their definition of cGMPs continue to change. In past years, we have seen that QA managers in the pharmaceutical industry generally knew what they could inspect from an FDA audit. The inspections would […]
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Latest Trends in cGMP Compliance
Latest FDA and cGMP Compliance News Here are some current cGMP compliance trends we are hearing from some of our industry contacts. We are seeing in the last year or two an emboldened FDA, which is trying to measure up under a Congress more interested in food and drug safety. For example, we have seen […]
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6 Tips to Avoid 510(k) Submission Delays
We often get questions about how medical device companies can minimize delays with FDA in having their device cleared. Note that some delays are not in the hands of the submitter, but there are surely some easy steps that you can take that will streamline the 510(k) submission process. Here are some easy tips to […]
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