S88.01 Models and Commissioning / Qualification Mapping

Overview:

The following paper makes a link between ISA-S88.01 Batch Control Models and Terminology, and key features and terminology, used in ISPE Baseline Pharmaceutical Engineering Guide: Commissioning and Qualification. The problem is how to extend effects of modular design, based on S88.01 models, to other activities: application software development, FAT, commissioning, qualification & validation. The solution is the linkage between different islands of terminology, knowledge, experiences and views: design, user, control system vendor, package unit vendor, quality assurance and maintenance. S88.01 physical model, procedural control model and process model provide consistent definition of commissioning, qualification and validation scope. Implementing the proposed method results in reduction of manpower, expenses of documentation and project implementation time.