If an IQ and OQ are completed on the EWI, do we need to perform PQ? If yes, what is involved in PQ? Do we validate each recipe three times? Do we validate only critical recipes?
Is this EWI, part of a MES system?
It is part of the manufacturing electronic system (MES).
In my experience if you opt to do a PQ, then this would involve one complete batch run where this EWI is part of the run.
In my opinion one run is sufficient here, it would be different if you were process running.
Correction, it is Manufacturing execution systems.
We have completed a through IQ and OQ. Do we have a choice for PQ?
You have a choice to do a PQ as long as you state this clearly in your validation plan what approach you are taking and the justification for this approach.
Good day
The acronym MES is just that; an acronym. It tells you nothing about the function or role of the equipment and or software being used in the regulated process. So the first thing to be done is a Validation Risk Assessment (VRA).
This VRA has nothing to do with company risks or patient risks or commercial risks. It is simply and solely used to judge and define the degree of validation that is required to ensure that all user defined (in the URS) and regulatory defined (in cGMP) requirements can be verified as incorporated and or complied with. It is a mandatory requirement that this VRA is used and it is a mandatory requirement that the outcome; the final justification for the scope of your validation is documented.
When the execution of the VRA indicates that validation is required it is also designed to indicate the requisite appropriate scope and intensity demanded. Thereafter the standard validation train of document must be used.
URS – VRA – DQ – IQ – OQ – PQ
As we have discussed before in this forum; all these documents are mandatory requirements. They also inter-relate and cascade in generation and in execution. Although it is possible to have brief documents or combined protocols, simply to leave out one; is to leave your validation seriously flawed. To completely omit the PQ makes a complete nonsense of the whole validation concept and regulatory requirements.
Regards
Alex Kennedy
Alex,
What regulation or standard mandates those exact documents? My knowledge is limited to medical devices so maybe you’re coming at it from a different sector.
US FDA 32 CFR 80 and ISO 13485 only require that equipment used in the production process is validated (if outputs are not 100% verified, etc.). They do not prescribe how or what documents are required.
These, especially IQ, OQ, and PQ, are quite commonly used (but as Graham notes, PQ is quite frequently not applicable or somehow covered under the OQ effort).
Good day
I have worked in and with the medical device industry for many years and we supply validation documents and document packages to the industry on a daily bases. The regulations are detailed in 21 CFR Part 11/200/210/820, however there is a great deal of spread from other individual regulations and cross over between the eight FDA internal divisions. Further to this the interpretations and precedents are contained within the guidance documents and warning letters.
The PQ is always required. PQ is the verification that the top level User Requirements Specifications are satisfied. This can be in the form of a Performance Qualification (P1Q) or a Process Qualification (P2Q).
For Example;
Top level URS for quality water system (generated by end user).
I want a daily supply of 25 Litres of USP 26 quality water in room 16.
A Performance Qualification (P2Q) would be used to verify that the URS was satisfied.
The IQ and OQ would verify all the other attributes that QA/QC and Engineering would have added to level two of the URS, such as:- pipe / valve / tank / pump / filter material quality and installation. Safety, calibration, cleaning and maintainability, and so on.
But the thing the regulators will audit you for - is did you end up with what was specified in the URS.
Further descriptions and procedures are available as a free download SOP.
Click here for ‘SOP for Equipment Validation’
.
Regards
Alex Kennedy
I would like to suggest that “the PQ is an essential tool in the validation toolbox.” I, too, have been doing validation for many years now and the PQ is, without question, a useful method in many cases. At least in 21 CFR 820, however, there is no requirement specifically for PQ; only for validation. We do a risk-based validation and include PQ only when it makes sense. We document our decision on how to validate in the V&V Plan and provide sufficient justification and rationale for our decisions. It’s never been an issue with FDA or ISO auditors.