9/10 September 2021
Again and again, the question arises as to whether a bracketing approach - i.e. selective skipping of individuals tests - may be used for the qualification of identical pieces of equipment.
Chapter I (Medicinal Products) and Chapter II (APIs) of the EU GMP Guide do not provide any information about that. Annex 15 to the EU GMP guidelines isn't any better and also FDA's Process Validation Guidance doesn't include any information.
However, Part IV to the EU GMP Guidelines ("GMP for ATMPs") now provides an interesting suggestion in Chapter Qualification and Validation under 10.25: "Likewise, when validating several identical pieces of equipment, it is acceptable for the manufacturer to establish a suitable testing strategy based on an evaluation of the risks."
Now the dilemma is: when are pieces of equipment identical? Does it apply to identical facilities too? However, another question arises: what does "identical" mean? Same serial number, same production site...? And who does confirm that something is identical? The manufacturer? The qualifier? The QA... ?
Those interrogations remain difficult. One first needs to demonstrate that the equipment is really identical, taking into account the uncertainties named above. Moreover, a detailed risk analysis has to be performed which precisely justifies the reduction of tests. In such conditions, would it really lead to time and cost savings? Besides, one should note that Chapter IV of the EU GMP Guide explicitly only applies to ATMPs. Is it transferable to other products at all?
Conclusion: even if a few suggestions have been provided in Chapter IV of the EU GMP Guide (GMP for ATMPs) on the qualification of identical pieces of equipment, a bracketing approach applicable to other products remains questionable.