The International Society for Pharmaceutical Engineering (ISPE) has released the second edition of its guide to good engineering practice (GEP).
The Good Practice Guide: Good Engineering Practice aims to define the practices and processes that support and enable the design, delivery, and operation of engineered systems. The scope of GEP covers the lifecycle of engineering projects and engineered systems from design to retirement. The guide considers the range of pharmaceutical engineering activity and identifies attributes of GEP within it, including how GEP relates to and interfaces with GxP.
Updates for the second edition include alignment with current industry practice, particularly with respect to the second edition of the ISPE's Baseline Guide: Commissioning and Qualification which incorporates ASTM E2500, EU GMP Annex 15, ICH Q8, Q9, and Q10, and applicable regulatory guidance. It also incorporates the concepts and application of quality risk management, specifically the application of GEP as an enabler for integrated commissioning and qualification.
“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 C&Q, CAI. “The adoption of GEP can lead to a balance of expenditure and activity in relation to benefits. The 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.”
