I'm developing a manufacturing platform from R&D for a medical device. Would I need to do IQ/OQ/PQ on equipment that has been used historically in R&D and will be used in manufacturing or can I write a justification that this equipment is exempt?
Thanks very much for the input.
As I'm sure you are aware, equipment validation is a critical component of manufacturing; even slight inconsistencies can lead to serious issues. FDA's 21 CFR 820.70(g) states “Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.”
It isn't common for R&D equipment to meet FDA requirements. Does this equipment have documented requirements, and can you provide proof that the equipment consistently manufactures products that meet quality specifications? What is the risk to patients/users/business if the equipment isn’t set up properly or is run at the edges of the operating ranges?
IQ, OQ, PQ are methods for demonstrating that equipment offers a high degree of quality assurance, such that production processes can consistently manufacture products that meet quality requirements. Unless the R&D equipment has gone through this rigor, I suggest doing IQ/OQ/PQ.
Lisa Grosskopf, Chair, Medical Device Division
Lisa brought up some good points about equipment used to manufacturer medical devices. If you have not read the GHTF (Now IMDRF) guidance document on Process Validation then I suggest you download a copy (free) and read it. GHTF SG3 - QMS - Process Validation Guidance -January 2004 (imdrf.org)
Also here is a link to the FDA's presentation on process validation.. download (fda.gov)
One thing to point out. Equipment is qualified (IQ/OQ) processes are validated (PQ). As Lisa pointed out use risk when setting up any protocols for your validation. If the equipment is being transferred to mfg, then this becomes part of your design transfer. Not all processes need to be validated (ref section 3.2 of the GHTF document for examples), but the equipment used should be qualified.
Do you have a good process validation SOP? If not you might want to start there. You might be able to do a justification for parts (like IQ/OQ), but you will spend more time defending it than just doing one.
If you have any questions to not hesitate to reach out. firstname.lastname@example.org
Principal Consultant & Past Biomedical Division Chair
Thank you Lisa. Very helpful.
Thank you John. Also very helpful.
I concur with Lisa and John's guidance.
In summary, the equipment needs to be qualified and process validated as well as having a documented process control approach, which is risk-based, and having established acceptance criteria.
Some items to consider, as you qualify your R&D equipment or other for production use:
(1) Calibration and Maintenance - including replacement part equivalency and proper controls
(2) Manufacturing Environment - proper controls for the type of production being done - sterility impacts, ESD, etc.
(3) Test Methods - Qualified (documented) verification to external standard or custom criteria as established; reminder on repeatability and reproducibility with multiple gages and/or personnel.
(4) Overall QMS documentation/Process Control that minimizes opportunity for product not meeting requirements as well as providing a good design (as applicable) / process baseline to facilitate your post market surveillance process (complaint).
If you are using equipment for a regulated environment, the appropriate controls should always be utilized to meet QSR - 21CFR820 requirements and/or ISO13485-2016 and associated applicable standards. A good quality approach makes product compliance a reality.
Yes you must do commissioning (IQ, OQ,PQ) since the usage in R&D is not the same as using equipment for productions specially if it be used for regulatory requirements.