Revised Draft Aseptic Processing Guidance Debuts

Jenevieve Blair Polin

FDA published the long-awaited draft of a new aseptic processing guidance last fall. This document, �Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing�Current Good Manufacturing Practice,� was issued for public comment on September 3, 2003. The comment period closed November 4. The chair of the working group, Rick Friedman, team leader, guidance and policy, Office of Compliance in FDA�s Center for Drug Evaluation and Research (CDER), has labored for years along with his colleagues to create a practical and useful document. While CDER is leading the revision of the document, Friedman stresses that it is the product of a strong collaborative effort. The draft is officially a joint document from CDER, the Center for Biologics Evaluation and Research (CBER), and the Office of Regulatory Affairs (ORA). The vector for collaboration with industry was the Aseptic Processing Working Group of the Product Quality Research Institute (PQRI; Arlington, VA). Its 41 members include six from FDA; the rest are from industry and academia. 

FDA received more than 60 letters and electronic submissions in response to the draft. The comments and critiques that FDA received raise issues to be �fine-tuned� on each of the 60 or so pages of the draft, says Friedman. Incorporating these changes to produce a final version, he adds, will take time. �It�s not going to be three months,� he says, �but soon.�

�Anybody can read what the guidelines say, but in actuality how do you really design your validation protocol so that you�re meeting the spirit and the letter of the requirements?� asks Mike Akers. This is the question he helps pharmaceutical manufacturers answer.

The biggest issue in FDA�s revised aseptic processing guidance, Akers adds, is the enhanced requirement for media fills in process simulation. �The guidance document now puts more emphasis on what you would call worst-case conditions. For example, conducting these media fills with operators who are fatigued, rather than at the beginning of a shift,� Akers explains.
Readers may view the draft guidance at   

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