Anyone ever had to integrate testing into a project that has to be GMP conform?

Hello MOT,

I have a question regarding integration of testing in a Project that has to be GMP conform ( Good manufacturing practice | European Medicines Agency) .

Did you ever do such a project? How did you structure the testing activities and reporting?

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Hi @restertest,

yes the company I work for does frequent GMP/GxP projects from infrastructure to software development and implementation of standard systems.

Testing is integrated as an activity to confirm the explicit requirements and document the facts. In a classic V-model way, though agile ways are getting frequent. the testing activities are usually listed in a test case management tool with approvals. Also documents, like test report documents, needs digital signatures and are usually also logged in a system.

could you elaborate a little more on your challenge?

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Hi @jesper - do you have any roadmap or test plan. I never did such a project so I am not really sure how to start and what to do in order to on the one hand assure Quality and on the other hand document everything so that it is GMP conform.

I can give you some pointers :slight_smile: Consider two activities for you:

  1. verification of requirements (aka testing). Set up tests to verify the requirements. List the tests in a doc based on this The One Page Test Plan | Ministry of Testing
    Do the testing and capture objective evidence for the tests passing. screenshots of the places where the tests confirm the requirements.
  2. In the GMP sense, quality assurance is more about confirmation/compliance with a process. You state in the test plan what you are going to do - and in the test report what you did. The process - not the test outcome. eg: did you have the approval of the test plan, do you have screenshots etc? Often Quality Assurance is based on the company processes or specific EMA guidelines.

hope this helps :slight_smile:

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Hi @restertest

I’ve done software and equipment validation before for the acceptance (user side, not on the development side) in the GMP environment. For the computerized system validations there is a separate GMP part call GAMP (Good Automated Manufacturing Practice). This describes how systems and software (dependend on level of complexity) needs to be validated for use in a GMP environment. I think GAMP5 is the current version.

Hope this helps