Qualification and Calibration Status in Process Validation Protocol

Dear All,
In Annex 15 of EU GMP, the below is stated:
Section 5.22. Process validation protocols should include, but are not limited to the following:
vi. List of the equipment/facilities to be used (including measuring/monitoring/recording equipment) together with the calibration status

Could you please share your opinion on this matter? How do you interpret this info?

  • Does it mean that the qualification & calibration status of the equipment and instruments respectively should be checked prior to the production of validation batches by Process Validation Team? OR

  • Does this mean the qualification and calibration status of all potential equipment and instruments respectively should be checked for a product by Process Validation Team?

  • And is it adequate to check if the machine or instrument is qualified or calibrated for the first time? Is it required to check for the re-qualification and re-calibration status?

Many thanks in advance,


It means a listing of the equipment in the ‘process validation protocol’ with a process description. They should already be commissioned and qualified (IQ/OQ/PQ) and all you do is list the document number including the date.

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Thank you very much for your response. Do you believe we should include the initial qualification date only in the process validation protocol? or should we include re-qualification dates as well?

Also, what do you do if you dont know exactly which balance will be used for weighing the tablets in advance? Is it acceptable that we check calibration status of all balances in the building?

Process and Lab equipment need to be commissioned and qualified only once (unless moved). Thus, the protocol should only have the date that people sign (and initial) and date the protocol. QA has the last signature and assign an effective date.

The process validation protocol should list all balances that will be used in the manufacturing process along with the protocol number and QA effective date.

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Thank you very much for your prompt response.

I guess the same counts for the qualification of the process equipment. (i.e. blender)? it is adequate to include first qualification date?

Yes (but most pieces of equipment need to be commissioned and qualified only once). The more information the better. Be sure to list the final QA effective date.

that was very helpful. Thank you very much.

Just from your questions I think you will need a ‘cleaning validation (CV)’ and ‘process validation (PV)’ strategy. In reality these strategies will depend on the applicable regulator and where you sell your products.

It makes no sense to have your health based limits calculated based on the American ADE when you sell into Europe where the PDE is required (they can be the same but the formulations can be different). In fact the European regulations are in chapters 3 and 5 of the Eudralex. I always get my ADE or PDE values from www.affigility.com which has a registered toxicologist. It costs about $600-700 USD per API,

Sorry, wrong website.

  1. As 5M affects on the quality as well as efficacy of products. Main thing is for adding the details in protocol to help to get exact root cause if any OOT/OOS/ or any incident occurs in future to identify.
  2. This will help you to aware about or to find out exact current status of equipment/instrument, because a small error can raised major problem.

So, I think this is good for GDP and GMP.