The Importance of Good Engineering Practice in the Pharmaceutical Industry
Late last month, ISPE published the 2nd Edition of the ISPE Good Practice Guide: Good Engineering Practice. This revision comes a decade and a half after the original guide was published and is the culmination of a year-long effort of a multi-national, cross-functional team of industry experts. Perhaps now is a good time, then, to review why Good Engineering Practice (GEP) is important to the pharmaceutical industry, what benefits the Good Engineering Practice Guide offers, and the reasons why the Guide has been revised.
Why is Good Engineering Practice important to the pharmaceutical industry?
Good engineering practice provides standardized approaches that provide a high degree of certainty that design and delivery of engineered systems are successful, safe, and cost-efficient. In short, good engineering practice is good business practice. However, beyond good business practice, for pharmaceutical engineers, good engineering practice exists in the context of the regulated industries and for the purpose of supporting and enabling Good Manufacturing Practice (GMP). The ultimate purpose of GMP is to provide benefit, and to prevent harm, to the end user (patient) of the drug product. Thus, by extension, part of the purpose of good engineering practice is to provide benefit, and to prevent harm, to the end user of the drug product produced with a process that uses engineered systems designed, delivered, and operating in a manner fit for purpose.
Ultimately, as with “good” regulated practice (GxP), good engineering practice is “good” as a result of reliable, cost-effective delivery of quality of work. With good manufacturing practice, manufacturing practices are “good” when they reliably result in manufacturing of drug products that meet their quality attributes, specifications, and requirements. Likewise, engineering practices are “good” when they reliably result in project deliverables that meet stakeholder requirements and engineered systems that are designed, delivered, and operate throughout their lifecycle, from conceptual design through decommissioning, in a manner fit for purpose and meeting user requirements and stakeholder expectations. Therefore, particularly for regulated industries, engineering practices are “good” when they result in manufacturing facilities and systems that function efficiently, safely, and reliably to produce a product that meets quality specifications. However, the motives for aspiring to practice “good engineering” are wider than the need to comply with GxP regulatory expectations; they encompass productivity, safety, and other business-related drivers.
What are the main updates or changes in the new edition?
This revision of the Good Engineering Practice 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. The scope of good engineering practice covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. Good engineering practice provides a foundation required across the pharmaceutical industry that other areas, such as GxP, build upon.
This revision of the good engineering practice Guide, rather than merely listing the many processes and practices that fall within the scope of good engineering practice, organizes and visualizes good engineering practice as a holistic, lifecycle process for the design, delivery, and operation of engineered systems:
Since publication of the first edition of the Good Engineering Practice Guide in 2006, the pharmaceutical industry and regulators have developed industry standards, best practices, and regulatory guidance around topics that relate to good engineering practice, culminating in particular in ISPE Baseline Guide: Commissioning & Qualification, Second Edition, published in 2019. The revised Commissioning & Qualification Guide incorporates ASTM E2500, EU GMP Annex 15, ICH Q8, Q9, and Q10, and applicable regulatory guidance.
This revision of the good engineering practice Guide incorporates, as applicable, the revision to Commissioning & Qualification Baseline Guide, and defines and clarifies good engineering practice as an enabling process for QRM-based integrated commissioning & qualification. Additionally, the revised C&Q Baseline Guide references an Engineering Quality Process (EQP) that aligns the application of good engineering practice under the overall Pharmaceutical Quality System (PQS) for QRM-based integrated commissioning & qualification. This revision of the good engineering practice Guide describes the Engineering Quality Process, its relationship to the overall pharmaceutical quality system, and its application to facilitate good engineering practice as an enabling process for QRM-based integrated commissioning & qualification.
Why should someone purchase the Good Engineering Practice Guide?
First and foremost, the good engineering practice Guide is useful for anyone who wants to be informed about current approaches in good engineering practice and benefit from cost efficient, best practices in industry. Running a business efficiently requires working practices that will deliver optimum value for a given scope of work. 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 good engineering practice.
The intended audience for this Guide includes project, process, and other engineers who are involved in the design, delivery, and lifecycle management of engineered systems in the pharmaceutical and other regulated industries. This Guide may be beneficial to other stakeholders involved with such engineered systems, including business, manufacturing/operations, and quality.
Conclusion
On behalf of my co-lead, Joerg Block, and the entire revision team, I thank ISPE for the opportunity to revise and update the good engineering practice Guide, and I thank the dozens of industry professionals who reviewed and provided feedback and comments during the review process. We believe this revision represents current and best industry practice for good engineering practice and will further position good engineering practice as an enabler for QRM-based integrated commissioning & qualification processes. On a related note: the good engineering practice Guide revision would not have been successful without everyone who volunteered to help and contributed to its success. If you have ever considered getting involved in ISPE efforts such as these, please do so! Whether you raise your hand to contribute to an existing need or see a need and offer to help meet it, ISPE will gladly give you the opportunity to contribute.
