ICH Q10’s Role as Guidepost on Pharma Journey from “Blind Compliance” to Operational Excellence Affirmed at PDA/FDA Workshop

ICH Q10 is serving as an important guidepost on pharma’s journey from “blind compliance” to operational excellence, NSF-DBA Senior Partner Neil Wilkinson affirmed in his opening presentation at a PDA/FDA workshop in mid-September.

The workshop brought together senior quality and operations managers and key regulatory compliance officials to: ● take stock on where the pharmaceutical industry is on the quality systems implementation pathway ● examine the role that executive management plays in setting the pace of progress, and ● brainstorm on how to increase that pace moving forward.

In providing the context for the workshop discussions, Wilkinson drew on his extensive experience in pharma operations and quality management at AstraZeneca, his service as a representative of the European Federation of Pharmaceutical Industries and Associations (EFPIA) on the ICH Q10 Expert Working Group, and the insights he has gained as an industry consultant and trainer.

He assessed the past and current state of industry’s manufacturing and control performance and the regulatory environment it has been operating in.  He then went on to explore the role that the evolving quality systems concepts enunciated in Q10 can play in addressing the shortcomings and strengthening quality cultures.

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