Compliance Tips

  • 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... Read More »

  • FDA cGMP Compliance News and Tips by

    Below are the original 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... Read More »

  • 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... Read More »

  • 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... Read More »

  • 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... Read More »

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