FDA is modeling its upcoming quality systems guidance on manufacturing consent decrees.

"Looking at these consent decrees and being proactive in this guidance, we're hoping to prevent future types of actions where these things have failed," CDER Office of Compliance Division of Drug Manufacturing & Product Quality Director Joseph Famulare said during the PDA/FDA Regulatory Conference in Washington, D.C., Sept. 21.

The quality systems draft guidance is one of five guidances slated for release in October (see ¹ Also see "NDA Reviews Will Be Risk-Based Under FDA Good Manufacturing Initiative" - Pink Sheet, 27 September, 2004. ).

Famulare said the guidances will be published along with four manufacturing white papers and eight other agency documents.

The development of the draft guidance for industry is one aspect of the FDA's quality systems initiative; the agency also is aiming to harmonize good manufacturing practices and implement quality systems principles internally.

The initiatives are part of FDA's "Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach" program announced in 2002 (² [A#00640340001], p. 3).

FDA plans to begin applying its quality system techniques internally to warning letters, recalls, the pharmaceutical inspectorate, the process analytical technology team and team biologics.

Furthermore, FDA intends to expand agency-wide the Center for Drug Evaluation and Research's practice of centralizing warning letters (see ³ Also see "GMP Warning Letters: FDA Approves 55% Of Field Recommendations" - Pink Sheet, 27 September, 2004. ).

The agency also is centralizing its quality systems work. "All of these programs will now report up to the new subcommittee in the FDA management council" called the Council for Pharmaceutical Quality, Office of Regulatory Affairs Consumer Safety Officer and Quality Systems Framework Co-Chair & Project Manager Patricia Maroney-Benassi, PhD, said.

Maroney-Benassi said the draft guidance will break out four major components of a quality system model: management, resources, manufacturing operations and evaluation.

The guidance seeks to address "the larger role of business practices and quality practices" and "a slightly smaller but more proscriptive role of the cGMP," Maroney-Benassi said.

"You'll have to tell us in your comments how well we struck that balance and how well we defined the requirements that come out of the cGMP versus the suggestions we're making for business practices," she added.

FDA hopes that the quality systems guidance will pave the way toward revising the GMP regulations.

"We see it as really a bridge to the next step," Famulare said. "How should we revise certain elements of the reg? Should we do it incrementally? Should we do it wholesale?"

The agency plans to use the comments it receives on the draft guidance to drive revisions of the regulations.

At the PDA meeting, a Pfizer rep suggested that industry may be looking forward to the publication of the guidance as a way of facilitating better communication of a company's quality systems to disparate regulatory agencies.

"It's very difficult sometimes communicating what your quality system is to an investigator, whether it's FDA or any other regulatory agency, because they're all looking for something different," Pfizer VP-Global Quality Operations Gerry Migliaccio said.

After hearing FDA's presentation, "I started to piece together the Pfizer quality systems into that guidance document to see how would I communicate when FDA" or the U.K.'s Medicines and Healthcare Products Regulatory Agency "or anyone else came into my facility and they asked, what is your overall quality system?" he said.

"I think this is a vehicle to communicate" one's quality approach in the context of the system described in the guidance, Migliaccio said.

[Editor's Note: A version of this story first appeared in ⁴ "The Pink Sheet" DAILY Sept. 22. Visit our website, www.ThePinkSheetDAILY.com, to sign up for a free trial.]

FDA Quality Systems Guidance To Be Modeled On Consent Decrees

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