This process is one of the most important in a GMP Project as it lays the expectation from the Client to the Contractor or Supplier.

This procedure/Form provides a checklist of the processes, documentation and testing required for the contract between Client and Contractor as well as for the qualification process. This document forms the basis of your Validation Plan.


What is this process and document about?

In order for a project to meet the expected outcomes, a quality management process helps to implement quality assurance and control measures.

As part of the Project Quality System, this Project Documentation and Testing Requirements plays a major part in the entire project GMP life-cycle (see flowchart below) or click here to open in PDF format E03-50-00_Project_Quality_Sys_Flowchart


GMP Project Testing & Documentation


The documentation and testing requirements (including qualification) and the party responsible are stated upfront. This simple procedure/form combined (2 pages) will prompt the format and extend of the activities and documentation for qualification.


GMP Project Documentation and Testing Requirements

Who needs this document?

  • Vendors – equipment fabricators and manufacturers;
  • Contractors – Design & construct turnkey; mechanical piping contractors
  • Projects, Validation, Engineering department
  • Quality Assurance
  • Manufacturing


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