Q: I have a question about FDA’s process control and training rules. The “Production and Process Controls” section of FDA’s Quality Systems Inspection Technique (QSIT), says the FDA investigator should “Verify that personnel have been appropriately qualified to implement validated processes or appropriately trained to implement processes which yield results that can be fully verified.”
That raises two questions:
- Can you tell me if this verification is for the personnel who perform any process control (fully verified and not fully verified) once implemented – or is it more for the “technicians and engineers” who analyze, document and if necessary challenge (validate) the process, before implementation? I would assume it’s for the second case, but 21 CFR 820.75(b)(1) says: “Each manufacturer shall ensure that validated processes are performed by qualified individuals.”
- What’s the difference in meaning between “qualified” and “trained”? And what should be the difference in terms of our process control documentation?
A: Persons who perform validation must be qualified to do so. Persons who operate validated processes must be qualified to do so.
In both cases, training to procedures, protocols, etc. is necessary. But so is hiring personnel with the necessary background, knowledge, education or experience.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Training is necessary to recognize defects that may result from the improper performance of the process.[/pullquote]
Training is especially necessary to recognize defects that may result from the improper performance of the process. So if the person does not have the sufficient background, knowledge, education or experience for process control, more training is required. But if the person does have the sufficient background, knowledge, education or experience, his or her CV and other certificates can provide the basis of qualification.
For fully verified processes, qualification can also mean showing that Operator #1 and Operator #2 both can achieve the same results from following the same process. You can prove this qualification with a gage R&R (repeatability and reproducibility) study or a proficiency test.
Answered by Denise Dion, Vice President of Regulatory & Quality Services at EduQuest (18 years as an expert FDA investigator and a co-developer and trainer of FDA’s Quality Systems Inspection Technique-QSIT). Denise also is the lead instructor for EduQuest’s QSR Compliance Basics: Complying with FDA’s 21 CFR 820 Quality System Regulation training class.