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What is Good Engineering Practice (GEP)?

Good Engineering Practice (GEP) includes the following activities according to the ISPE Baseline Guide Qualification & Commissioning:
  • professional and competent project management (processes, specifications, personnel)
  • professional and competent engineering design, procurement, construction, installation and commissioning
  • absolute compliance with all applicable legal requirements in respect of occupational health, safety and environment requirements
  • compliance with all requirements in respect of function and maintenance
  • absolute compliance with recognised industrial standards and statutory guidelines
  • appropriate documentation of established corporate processes and maintenance
  • documented proof of compliance with the relevant laws and regulations
GEP must generally be used for all facilities, equipment and technical systems. Furthermore, it is always mandatory where the functions or components of facilities have the potential to affect the quality of the medicinal product in a critical way.

[GMP MANUAL, Chapter 4.A.1]

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