Qualification is a process of assurance that the specific system, premises or equipment are able to achieve the predetermined acceptance criteria to confirm the attributes what it purports to do.
Validation is establishing a documented evidence to provide a high degree of assurance that a specific system, process or facility will consistently produce a product meeting its predetermined specifications and quality attributes.
Qualification is documented evidence that a specific equipment, facility or system is fit/ready for intended use.
Validation is documenting that the way equipment, facility or system used will result in product meeting its predetermined specifications and quality attributes.
Things are qualified: equipments, systems etc.
Process/Procedures (the way we use things) are validated.
Before you do validation on a process, you have to be sure that the equipment has passed qualification.
Systems (HVAC, Water, Compressed Air etc.), Equipments, Area, Facility, Analyst, Vendor are qualified.
Manufacturing process, cleaning process, analytical method are validated.
One of the clearer explanations I have seen!
Is this consistent with how the FDA uses ‘validation’ (e.g., in the Principles of Software Validation:
Seems here that things (software) are validated - as well as any process using the software. ISO 13485 also has some verbiage along these lines (software validation).
Don’t get me wrong, I like the definitions rajinderkaur put forth - just maybe a word of caution that they may not be globally used / accepted this way.
in simpler term… qualification is an act of putting in the criteria for the system to be accepted… based on the requirements.
And validation is the action to provide the evidence to proof the qualification criteria.
nice definition…but can u clerify more a bit…on the difference between …validation qualification nd calibration…mainly i wanna ask is calibration classified under qualification or validation.
Calibration is an part of qualification, actually, part of the IQ protocol. You need to clarify which one of instruments is critical (has direct impact to process) and than calibrate the same. Other instruments (have indirect impact-non critical) you will call indicators and there is not necessity to calibrate them.
So, calibaration is very important to approach IQ and take condition to open OQ story.
so as per ur reply…is it correct to say that calibration is a part of qualification and qualification is a part of validation.
Globaly…yes, you can say like that, but…perhaps is better to say…calibration is one of condition to make qualification, as well as qualification is one of condition to make validation.
Also, don’t forget…this is important and very clarify (from the first post)…
''Things are qualified: equipments, systems etc.
Process/Procedures (the way we use things) are validated.
Before you do validation on a process, you have to be sure that the equipment has passed qualification.’’
I would like to know if there is a temperature mapping protocol for qualifying a new fridge?
For temperature mapping of a fridge you need to take 9 data logger. You need to place all the 9 data logger in a single position i.e. center point of the fridge being calibrated and take data continuouslt for 1 hour with 1 min time interval. This is just to check reading variation for data logger to data logger. Secondly, you need to select 9 scattered positions to set 9 data loggers and collect data continuously for 24 hours with 5 minutes interval. In each cases you ned to ensure that readings for all the data loggers must be within the preset acceptance limit ( both for single location & multile locations. For mapping studies you must need to know the W x L X H of the fridge’s and as per that measurement you need to select 9 scattered positions. Hope this will helpful.
Any guidelines regarding this pls
Equipments are qualified.
Procedures are validated.
Performance Verification of an Equipment is called Calibration/Performance Qualification.
Performance Verification of a Procedure is called Validation.
There is a difference between calibration and Performance verification of an equipment.
Conventionally we speak Calibration for every equipment,It is not advisable to use the word calibration to all the equipments[USP<1058>].
Calibration : Using a standard, the equipment is adjusted to the standard value, This is called calibration Eg: pH, Conductivity meter etc…
Performance Verification: Using a standard, accuracy of the equipment is verified(No adjustments are made with respect to standard). Eg: HPLC,GC etc…
Yodon, I’m not sure that you’re correct when you classify software among THINGS. I’d say that software is much more a PROCESS, rather then a thing…
Question — I agree the IQs and OQs are part of the “process of assurance”.
I think is can be debated that PQs could be Validation…it depends on how a company looks at PQs, and it also depends on what the PQ is looking at …e.g. ability of a sterilizer to properly sterilizer is load type.
There is no one answer for this question. In my book IQ/OQ are for basic functions and operations and installation (needed to be tested once). PQ is for functions which may involve set-up procedures (like a filler, or an autoclave or a depyrogenation oven), or may have statistical control, and repeat runs.
PV should be done with heightened inspection of a full operating procedure (batch record, or master production record). But with a few additional inspection steps. But otherwise the PV really is to perform the operation as it would be done normally (same operators, same equipment, same procedures, same batch record).
For example, in a PQ, I wouldn’t mind the validation and engineers performing the testing. But in a PV, the day-to-day operators really should be doing everything (because that is what you expect normally and is your “process”.
So what requires a IQ/OQ/PQ: Sterilization always requires a PQ. Lines and/or trains should required a PQ.
What requires IQ/OQ: Simpler equipment should required IQ/OQ.
What requires IQ: Maybe an instrument, and the calibration certificate is attached. If it can be calibrated, then it should pass any OQ testing you might throw at it.
What about computer systems? Computer systems should require IQ/OQ (PQ should be reserved for capacity handling).
What requires process validation? Commercial processes, or aseptic clinical process where human trials are involved.
Then there is Verification. I reserve verification mainly for change controls to verify that there is no adverse impact. I might also do verification for a legacy process which may not have been properly “validated” formally, so testing is required, but the risk of compliance is very low (again because it is legacy with no reason to question the quality of the process).
I agreed with Jared. In general, all special process require process validation (IQ/OQ/PQ). For example, Ultrasonic Welding, dispensers, Heat staking, sterilization etc. which requires to Knob set up Input parameters for variables outputs. Now, the non special processes like like simple arbor press, assembly fixtures which does not require to setup Input parameters does not require validation (PQ), just the qualification (IQ/OQ). So, if you want to perform process validation, you need make sure the equipment, fixtures system etc are qualified. Now, the process validation is performed on individual process. However, you need to perform Full line Validation to make sure the whole production line with integrated processes perform under production environment consistently produce a product meeting its predetermined specifications and quality attributes.
as someone above mentioned equipment, system requires qualification.
So, no mateer what you do qualification or validation, you need make sure equipment system are qualified.
In which phases of qualification (OQ or PQ) the following parameters/ actions would be established or defined?
- Operating range
- Alert and action levels for key quality attribute
- Corrective action responses.
Please share your valuable comments.
Good question. I just posted a very long discussion about this in another topic about “Sample Size”. Here is the link:
My answer to your question is:
OQ should test what the equipment can run at,
Engineering studies should determine what the process should run at (optimal). This can also help know where to put your action and alert levels.
PQ should establish that the process is repeatedly run at the target values (nominal) without issue - showing that the process is repeatable.
I submit that engineering studies should be done after OQ and before PQ.