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QUALIFICATION|IQ|DQ|OQ|PQ|URS|FAT|SAT
5 Comments / Standards / By Sajjad Ahmad
Qualification is documented evidence that all the equipment, system, facility,
or utility are designed, installed, and operated in such a way that complies
with GMP requirements and produces products of the desired quality all the
time. Qualification is a part of validation and consists of following
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification(PQ)
If we discuss in a detailed manner then some key factors are also the part
of qualification which are as follow,
User Requirement Specifications(URS)
Factory Assessment Test( FAT)
Site Acceptance Test ( SAT)
Explanation
To understand the qualification system i will try to explain it with
a simple example which is as follow,
For a specific job, a specifically qualified person is required.
For example in the pharmaceutical industry for the post of
Production Pharmacist, the qualification of a person should be
Pharm D.
Only that person will qualify for the post who have required
qualification because if we hire a person with different
qualifications we will not be able to achieve the desired results.
In the same way, any new equipment, area, facility or utility
should only be used for a task in pharmaceutical industries if it
is qualified for that specific purpose
Now the question is what should be the qualification of equipment or an
area?
Who sets the qualification criteria for equipment, area, system,facility or
utility?
Answer of this question is very simple that
For this we have the URS.
URS (User Requirement Specification)
URS is a document that defines the requirement for use of
equipment, system utility or facility.
The first step for purchasing new equipment or to build an area
or system is the required specifications for that by the
concerned department.
For that, a document is prepared which contains all the
requirements which we need for equipment or facility.
This document is called URS and it is sent to the supply chain
department.
The supply chain department finds a suitable vendor against
that URS.
The audit of the vendor should be conducted and the vendor
should be qualified.
Also Read:
GMP vs cGMP and 21 CFR.
Explanation
Everyone in daily life prepares URS for routine purchasing but
it may not be in a written form.
For example, when we want to purchase a mobile phone we
decide which type of features should be present in that mobile
phone e.g RAM size, storage memory,Battery storage, Screen
Size etc.
We prefer to purchase a mobile phone from a reputable shop.
In the same way for pharmaceutical purchasing of any
equipment first, we prepare URS in written form which contains
required features and then we send URS to the supply chain
department.
Supply chain department sends this URS to the vendor.
URS will include all the requirements which are as follow
Capacity Requirements.
Design Requirements like dimensions, MOC.
Software Requirements.
Safety Requirements.
Cleaning Requirements.
Operational Requirements.
Power Consumption.
Working Accuracy.
Lubrication Requirements.
Example
Suppose we want to buy a Bin Blender for mixing area in the
pharmaceutical industry.
URS for Bin Blender will include
The dimension of Bin Blender according to our area where it is
to be installed.
The material of construction like 304,304L or 316 or 316L.
Software Design and PLC to control the Blender parameters
like a touch screen with a graphical view etc.
For operation, it should have a maximum 30 rpm, baffles
installed and pneumatic feeding system.
For safety, it should have a safety frame and frame opening
alarm.
For Cleaning it should have a CIP system installed.
For power consumption, proper electrical wiring requirement
and horse-power of the motor is given.
Design Qualification (DQ)
Design qualification is documented evidence that the required
equipment system, facility or utility is designed according to the
URS.
After preparing a URS by the user and its delivery to the
vendor, the vendor prepares a Design document according to
the URS mentioning all the requirements of the user in
technical format and it is sent back to the end-user.
Users carefully read every point and match it to URS and make
changes if any.
If all the requirements are according to the URS then this
document is signed and the purchase order is generated and
sent to the vendor.
DQ allows vendors to start manufacturing.
Design qualification is mutual understanding and agreement on
the defined Design of equipment or system by both vendor and
user.
Also Read
Difference between Validation & Calibration.
FAT (Factory Acceptance Test)
FAT is a Factory Acceptance Test.
When DQ is completed and the vendor starts to manufacture
the equipment the end-user visits the vendor facility to ensure
that all the working is carried out according to URS and DQ.
End users also inspect the functions and operation of equipment at the
vendor site before dispatch to ensure that equipment is according to
URS and DQ.
SAT (Site Acceptance Test)
SAT is a site acceptance test.
SAT is Performed at a user site.
When equipment arrives at the target place it is inspected by
the user to ensure that there is no damage to the equipment
during transportation.
Its dimension and specification are the same as mentioned in
DQ and URS.
It is fit for installation.
Installation Qualification
It is documented evidence that the required equipment, facility or utility is
installed according to the design requirements and URS.
URS may include the following,
Identification of equipment,make, model number, serial number
etc.
In Installation qualification, it is verified that the equipment is
properly installed and occupies proper space according to DQ.
All the connections are made properly.
Installation does not create hindrance to work.
Verify that all the safety features are properly installed
according to Design Qualification and URS.
Verify all the cleaning methods.
Verify all the spare parts and components.
Verify specific documentation e.g equipment manual, SOPs etc.
Verify drawing.
Cables and connectors.
Verify calibration records.
Verify MOC.
Example
To understand installation qualification take an example of Bin Blender.
After SAT Bin Blender is installed in a mixing area.
All the electrical supplies are checked that they are properly
connected.
Safety alarm is checked that it is installed.
All the spare parts are verified.
MOC (Material of construction) has verified according to the
URS that it is 316L.
It is ensured that all the manuals and drawing are provided by
the vendor.
Operational Qualification
After installation qualification, the equipment, facility or utility is
ready for operational qualification.
Operational qualification is documented evidence that the
required equipment, facility or utility works according to
requirements.
Operational qualification is checking the operation of each
component of equipment.
Operational qualification is performed without load means in
empty or as built conditions with supplies and connections etc.
Different ranges and parameters are checked.
Low medium and high ranges are verified.
Verify working of safety parameters.
Operational SOPs are available.
Personnel training.
Assure that calibration, cleaning and operational parameters
are satisfactory.
Example
To understand the operational qualification take an example of a Bin
Blender which is previously installed according to Design qualification.
As we know that in OQ we test the components of equipment without load
and verify different operational ranges.
So we will check rpm of the empty Bin Blender.
We will note the following
rpm at the lowest speed
rpm at medium speed
rpm at highest speed
Working of safety alarm is checked that either it is operational or not.
Check that the cleaning procedures are according to requirements.
Also Read
Cleanroom classification in pharmaceutical industries.
Performance Qualification
Performance qualification is documented evidence that the
specific equipment, system or utility is working properly to give
desired results under real working conditions.
Performance Qualification is carried out under load.
We ensure that the equipment which gives acceptable results
without load will produce the same results under load.
Placebo batch is run to get results under load.
Example
A Bin Blender which is previously installed in an area and is
qualified in the operational stage is tested for performance
qualification.
We run the equipment in real working conditions under load to check
that all components produce the same results as in the empty pass
stage.
In the bin blender, a placebo batch is added and its rpm are
noted as in OQ.
Safety features are checked during working conditions.
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5 thoughts on “Qualification|IQ|DQ|OQ|PQ|URS|FAT|
SAT”
1.
VATSAL TIWARI
DECEMBER 7, 2021 AT 10:34 PM
Dear members,
During periodic requalification, during sterilization hold period
temperature drop observed upto minimum 120.3 degree in external
thermocouple in media cycle. However, f0 value found to be above 20
minutes is achieved in all external thermocouple.
Can we consider this cycles, as f0 value is achieved and BI also shows
no growth in all the location of sensors.
Refer below example:
F0 value must be 15 based upon a D-value of 2.5 minute as worst case.
F0 value is calculated based on ‘’D’’ value of Biological indicator from
COA.
e. g. Minimum 6 log reduction is required for media cycles.
‘’D’’ Value = 2.5 minutes then required f0 value should be = 2.5*6 = 15
minutes.
Note: If F0 value meets above requirements then cycle can be
considered valid.
please suggest.
Reply
2.
UNKNOWN
FEBRUARY 23, 2022 AT 1:34 AM
Thank you sir, this article is so helpful to me
Reply
3.
ANONYMOUS
MAY 15, 2022 AT 7:00 AM
Thank you sir, its helped a lot
Reply
4.
ANONYMOUS
MAY 16, 2022 AT 5:15 PM
Good exercise
Reply
5.
ANONYMOUS
MAY 27, 2022 AT 7:31 AM
nice article , basic with clarity
Reply
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