GXP Systems


Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities

  • Thursday, April 2, 2015

In February 2015, the US FDA released a draft guidance on the repackaging of certain products by pharmacies and outsourcing facilities. The closing date for comment was set for 17.05.2015, but when the actual guidance is e...

Program Management: some useful tips

  • Monday, March 9, 2015

I’ve been working in the life science industry for the last 10 years, in engineering roles at different levels. For the last number of years, I’ve been managing the validation program at a site where GxP Systems has a long...

New FDA Initiatives Launched

  • Saturday, December 13, 2014

The FDA has announced two new initiatives, one aimed at addressing medical device quality beyond compliance and the other allowing firms to voluntarily self-identify and correct possible regulatory violations instead of un...

Searching for Engineers - Quality over Quantity

  • Monday, December 1, 2014

The Irish life science industry is currently one of the sectors leading Ireland towards economic recovery. Regular news reports feature announcements from the Irish government on new jobs, expansion of facilities and new m...

Final Unique Device Identifier (UDI) Regulation

  • Tuesday, September 23, 2014

On September 24, 2013, the U.S. Food and Drug Administration (FDA) will release a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. It also applies to...

New FDA Guidance Modifies 510(k) Rules

  • Tuesday, September 2, 2014

On 28th July 2014, the FDA announced in a new final guidance a change in its approach to multiple predicate devices in 510(k) submissions and will no longer clear these devices because of the potential to cause long term d...

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