This sub-category of GEP relates to:

  • E03-0000  Project Management practices and
  • E03-5000  Project Quality System and procedures.

The templates are a must-have to ensure the smooth delivery of projects and the associated documentation.  It is a well known issue within the Bio-Pharma community of the transition of GMP documentation between Engineering and Quality Unit.

The processes, templates and forms in this sub-category of GEP:

  • In most cases, asking an Engineering Contractor to provide the “necessary GMP documents for the project scope” – will most often involve a lot of conflicts and misunderstanding of the “project scope”.  The flowchart provides a roadmap to simplify the communication.
  • provide a platform for a smoother project transition form Engineering to Quality Unit.

To view the E03-5000 Project Quality System flowchart in PDF – E03-5000_Project_Quality_Sys_Flowchart

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