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Regulatory News

PDA's Regulatory News is a source of pertinent news from all over the globe. This section is set up by distinct parts of the world so you can read what is crucial to you and your company.

Owners Responsible for Quality

Jan 30, 2017, 06:47 AM
News Source Link:
http://www.fda.gov/downloads/drugs/guidances/ucm353925.pdf
RegulatoryNewsDate:
Jan 27, 2017, 12:39 PM

The FDA released a guidance for industry on Nov. 22 describing how contract manufacturing organizations can use quality agreements to delineate their manufacturing activities to ensure compliance with current GMPs. According to this document, companies outsourcing pharmaceutical operations are responsible for the quality of the final product, not the outsourcing firm.

Comments on the guidance are due at any time.

regulatory-news-regions:
  • North America