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Nov. 28 — Drugmakers who use contract facilities now have final guidance from the FDA on quality agreements.
The final version of the guidance describes how companies involved in contract drug manufacturing can use quality agreements to ensure compliance with current good manufacturing practice (cGMP) requirements. Quality agreements between drugmakers and contract facilities define how each party will comply with these requirements.
The guidance should prompt drugmakers and contractors to review their existing agreements to make sure they comply with the guidance, an attorney told Bloomberg BNA.
Violations of cGMP requirements can result in being ordered to take corrective actions or not being approved to sell products. The guidance will help drugmakers ensure that any contract facilities they use are complying with these requirements. Drugs that aren’t manufactured in compliance with cGMP are considered adulterated.
A Food and Drug Administration 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 ( 11 PLIR 693, 5/31/13 ).
Cathy L. Burgess, a food and drug law attorney with Alston & Bird LLP in Washington, told Bloomberg BNA in a Nov. 28 e-mail, “the final guidance leaves no doubt about what FDA expects to see in a quality agreement.”
“It contains explicit recommendations regarding the organization and contents of these agreements, and emphasizes that quality unit representatives and ‘other relevant stakeholders’ should be actively engaged in drafting quality agreements,” 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.”
Burgess also said the guidance reminds industry that quality agreements should be available for review when the agency conducts establishment inspections.
“We can assume that the guidance is now the standard by which FDA Investigators will evaluate all drug manufacturing quality agreements. The parties to existing quality agreements 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,” Burgess said. “If their quality agreements take a different approach, they should ensure that the agreements clearly define the respective roles and responsibilities of the two parties for cGMP compliance.”
Deborah M. Shelton, a food and drug law attorney with McCarter & English in Washington, told Bloomberg BNA in a Nov. 28 e-mail “it looks like FDA has decided not to accept the request advanced by many within the industry, including some of the trade associations, to expand the scope of the guidance to include contracting research and development arrangements.”
“To the contrary, FDA notes in the final guidance that it has ‘clarified’ that the guidance is ‘limited to commercial manufacturing activities,’” Shelton said. “That said, FDA goes on to acknowledge that the principles may be useful in approaching other types of quality agreements, including those for research, development, or distribution, but that they are outside of the scope of the guidance.”
Shelton said “the acknowledgment of the potential utility of the guidance to quality agreements covering other types of activities is at least somewhat helpful, though falls short of the more definitive action that many had requested. That well may be a missed opportunity for the agency.”
The FDA said quality agreements should define manufacturing roles and responsibilities and should establish expectations for communication.
Specifically, the guidance said quality agreements should explain how the contractor will report manufacturing deviations to the drug manufacturer and how deviations will be investigated and resolved in compliance with cGMP.
Most quality agreements also explain how disagreements about product quality issues or other problems will be resolved, the guidance said.
A spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA) told Bloomberg BNA Nov. 23 that PhRMA is reviewing the guidance.
Additionally, a spokesman for the Bulk Pharmaceuticals Task Force declined to comment on the guidance.
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The guidance is at //src.bna.com/kjl.
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