GXP Systems


New & Revised Draft Guidances CDER is Planning to Publish During 2014

  • Friday, February 14, 2014

The FDA recently published a list of draft guidances that CDER (Center for Drug Evaluation and Research) is planning to publish during 2014. Here is a list of guidances that we think will be particularly interesting. CATE...

Medical Device Single Audit Program

  • Friday, November 15, 2013

This notice appears in today's Federal Register with more information about the IMDRF Medical Device Single Audit Program (MDSAP). http://www.ofr.gov/OFRUpload/OFRData/2013-27358_PI.pdf As explained in the notice, the MD...

International Inspections & FDA 483s on the Rise

  • Thursday, August 15, 2013

An interesting article from FDAzilla alerts non-U.S. pharmaceutical plants to the increase in the number of FDA inspections, and the difference in inspection standards for foreign and U.S. companies. The FDA is rapidly sc...

Further Analysis of New MDR Reporting Guidance

  • Monday, July 15, 2013

Further to our previous blog entry, we can now provide additional analysis of the new MDR Reporting guidance issued by the FDA last week. You can find a link to the guidancehere. The draft guidance takes a question/answer...

Unified Agenda – Regulations the FDA is Planning to Issue

  • Friday, July 12, 2013

The FDA has published a list of upcoming regulations it plans to issue in the next year. The complete list is available here. Of these regulations, following is a list that will have relevance for the pharmaceutical and me...

Final Rule on GMP Requirements for Combination Products

  • Monday, June 10, 2013

At long last, the final rule on good manufacturing practice (GMP) requirements for combination products will be published in the January 22, 2013 Federal Register. An advanced display copy of the final rule is available at...

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Recent Posts

Got the interview? Now time to get the job!

  • Wednesday, March 7, 2018

Establishing a Successful Data Integrity Management Culture

  • Tuesday, August 29, 2017

Is Over Regulation Stifling Innovation?

  • Wednesday, April 19, 2017

Implementing and Validating an ERP System – some tips

  • Monday, February 27, 2017

The Necessity of Independent Validation Services

  • Friday, October 14, 2016

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