In light of the new FDA final guidance on quality agreements, drugmakers and contractors “would be well advised to compare their existing agreements to recommendations in the new guidance to determine whether their agreements are consistent with these recommendations,” Cathy L. Burgess, a food and drug law attorney with Alston & Bird LLP in Washington, told me Nov. 28.
If existing quality agreements take a different approach than what is described in the final guidance, drugmakers and contractors “should ensure that the agreements clearly define the respective roles and responsibilities of the two parties” for compliance with current good manufacturing practice (cGMP) requirements, Burgess said.
The final version of the guidance describes how companies involved in contract drug manufacturing can use quality agreements to ensure compliance with cGMP requirements. Violations of cGMP requirements can result in manufacturers being ordered to take corrective actions or not being approved to sell products. Drugs that aren’t manufactured in compliance with cGMP are considered adulterated.
Burgess said “companies that have relied on checklist templates, or have quality agreement provisions built into commercial agreements are now on notice that FDA does not believe such agreements are adequate or effective in defining roles and responsibilities for manufacturing activities.”
An FDA notice announcing the final guidance was published in the Nov. 23 Federal Register (81 Fed. Reg. 84,597). The draft version of the guidance was issued in May 2013.
My full article on the guidance is at http://www.bna.com/fda-issues-guidance-n73014447801/.
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