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Parenteral Drug Association Connecting People, Science and Regulation ®

Commentary – PDA’s Metrics Activities

Nov 07, 2016

Since the U.S. FDA first introduced and invited industry feedback on its Quality Metrics program in Feb. 2013, PDA has been engaged in the public discussion to advance the principles of the program.

PDA held three conferences on the topic (Dec. 2013 & 2014/Nov. 2015) to gather input from industry and FDA. This input helped a PDA task force develop a position paper that was published in the PDA Journal (Sept./Oct. 2014). In 2015, the task force published results of a Quality Culture Survey in the Journal (Sept./Oct.), wrote comments on FDA’s draft Quality Metrics guidance, and I appeared at FDA’s public meeting on the guidance to present PDA’s position.

This July, FDA published its Quality Metrics Technical Conformance Guide: Technical Specifications Document, on which PDA is commenting independently. All PDA comments are posted on the website.

PDA is a scientific membership association. Our members are independent scientists, academics and regulators. We have no corporate memberships and  do not engage in any activity that represents the interest of any specific company or group of companies. That activity is the purview of trade organizations.

On many occasions, we evaluate the possibility of collaborating with other organizations, including trade organizations, in the development of “industry” positions, but in every case we weigh the benefit of such activity against our Mission “to advance pharmaceutical/biopharmaceutical manufacturing science and regulations....” In adherence to this mission, PDA has developed comments on the draft metrics guidance from a scientific point of view.

Several other organizations are working together on a “cross-industry group” response, but many of their comments are legal in nature and some of these groups have lobbied on this topic. As such, joining with these groups would give the appearance that PDA is lobbying. PDA has no mandate to lobby, so it does not lobby any government or regulatory agency. Based on the input of its all-volunteer Board of Directors, PDA has decided not to participate in an invitation to consolidate its comments on this topic with this “cross-industry group.” We will evaluate future opportunities for collaboration on a case-by-case basis as long as they are consistent with our mission and values.

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