ISPE Briefs: Revision to GEP Guide: A Link to QRM-Based C&Q
Since the first edition of the ISPE Good Practice Guide: Good Engineering Practice (GEP) was published in 2008, the pharmaceutical industry and regulators developed industry standards, best practices, and regulatory guidance around topics that relate to Good Engineering Practice, culminating in particular in the ISPE Baseline Guide: Commissioning & Qualification (Second Edition). The revised Commissioning & Qualification Baseline Guide incorporates ASTM E2500, EU GMP Annex 15, ICH Q8, Q9, and Q10, and applicable regulatory guidance.
The new ISPE Good Practice Guide: Good Engineering Practice (Second Edition) incorporates the revision to the Commissioning & Qualification Baseline Guide and defines and clarifies Good Engineering Practice as an enabling process for quality risk management (QRM)-based integrated Commissioning & Qualification. The revised guide also expands on content in the first edition and places more focus on operational engineering.
“Running a business efficiently requires working practices that will deliver optimum value for a given scope of work,” said Guide Co-Lead Chip Bennett, Associate Director, Global Commissioning & Qualification, CAI. “The adoption of Good Engineering Practice can lead to a balance of expenditure and activity in relation to benefits. Benefit is most likely gained when finite resources are focused on identified higher risk aspects or when high-risk aspects are more intensely controlled to enable reliable delivery and seamless production. Specific potential benefits include facilitation of speed-to-market of regulated products through efficient delivery of manufacturing facilities and systems and an optimized level of quality oversight, commensurate with the maturity of established GEP.”
“This guide considers the entire range of pharmaceutical engineering activity and identifies key attributes of Good Engineering Practice within it, including how Good Engineering Practice relates to and interfaces with GxP,” said Guide Co-Lead Joerg Block, PhD, GMP Compliance Engineer, Bayer AG PH-PS Engineering. “This guide defines Good Engineering Practice that supports and enables the design, delivery, and operation of engineered systems.”
The guide was developed through the collaboration of representative professionals from various sectors and geographic regions of the pharmaceutical industry with the intention of determining a common understanding of the concept and principles of Good Engineering Practice. Visit the Guidance Documents site at ispe.org/publications/guidance-documents for more information.
Meet the ISPE Staff: Elmarie Herloff-Petersen
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Elmarie Herloff -Petersen, Director of Events, Conferences & Digital Engagement
Tell us about your role at ISPE: what do you do each day?
As the Director of Events, I am involved in the planning, logistics, and program management of ISPE global events. My days are regularly consumed by meetings, but I try to manage this carefully to avoid frustration and meeting fatigue. My mornings are blocked to “get things done” and when the US wakes up (I am based in Belgium), I am available for meetings and direct follow-up with colleagues.
What do you love about your job?
The people, the absolute madness to deliver an event and, seeing the end-product delivered successfully, with everyone still intact. In this position, I am challenged enough to learn, and feel comfortable applying the skillset that I have developed, which in turn builds confidence. The confidence that the job gives me is priceless.
What do you like to do when you are not at work?
With three teenagers, and lots of animals, my husband and I sometimes feel like we are living on the edge☺. We are fortunate to live in the countryside, which allows for lovely lunch runs. From March to August, you will find me in our vegetable garden, rotavating, digging in compost, seeding, planting, and harvesting the bounty. The delight and abundance of our home-grown vegetables honestly makes me feel like a proper farmer. Whenever possible, I escape to my work room to design and produce leather bags to quench my creative soul.
