FDA, Now Your Guiding Light With Its Quality Agreement

In 2013, The US Food and Drug Administration released draft guidance (The Guidance) that is reminiscent of FDA's earlier stringent approaches to keep a strict eye on the drug hubs and facilities; the draft guidance comprises the FDA's regulations and approach-to-follow contract manufacturing arrangements for drugs.

DURHAM, N.C., Jan. 27, 2014 /PRNewswire-iReach/ -- May 28, 2013, witnessed the long-awaited FDA's attention to contract manufacturing arrangements for drugs, with its draft guidance that comprises FDA's terminology and outlook on having a specified quality agreement. The many existing pharmaceutical and biotechnology firms have been waiting with bated breath to receive FDA's final word on the know-how of outsourcing regulations, documentation and the response to current Good Manufacturing Practice (CGMP ). Now that it's out with public, it is time to know how does the FDA guides to combat the rules enforced by European Medicines Agency? And explains the fine nuances of a commercial and quality agreement.

(Photo: http://photos.prnewswire.com/prnh/20140127/MN52180)

Join this audio session by Alan G. Minsk on January 29, 2014 to get the detailed description of FDA's suggested uses for Quality Agreements that are known as written agreements, which can be put to use for setting the responsibilities of parties that have a mention in the contract manufacturing process, it is also used to maintain drug quality, safety and efficacy. Of course, the FDA's Guidance is not a rule imposed, but provides valuable insights that can help drug manufacturers to prepare contract manufacturing arrangements, that are in complete compliance with applicable laws and regulations.

The Guidance largely focuses on the crucial elements of a Quality Agreement , which are the various sections delineating the Owners' and Contracted Facilities' respective responsibilities for the manufacturing process and change control. The draft guidance highlights the that Quality Agreement must document each cGMP activity, in regards to the service and the operations that are covered by the Quality Agreement, along with specific party which is responsible for each cGMP activity.

Session highlights:

  • The importance of implementing a quality agreement — questions might be asked by FDA about managing contract service providers
  • List of potential table of contents in regards to quality agreement
  • Various obligations for the numerous stakeholders specified under a quality agreement as GMP compliance responsibility is of the application holder
  • How to develop a quality agreement, detailing quality departments of sponsor, with involvement of the vendor, flexibility is key and tips on working with vendor's QA
  • Co-dependence of a quality and relationship agreement
  • Tips on working with vendors to develop a quality agreement
  • What is the need of having a contract with your suppliers on quality?

For more information, visit http://www.audioeducator.com/pharma-biotech/fda-quality-agreements-01-29-14.html

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