General outline on equipment qualification

1. Presented by
T Ram Kumar
Associate

2.  Equipment qualification is an essential step that
companies need to perform in order to ensure that
their products or services meet manufacturing and
testing requirements and international standards.

3. Project Initiation
master validation plan
vendor management
Equipment Qualification DQ(FAT, SAT),
IQ, OQ, PQ

4. Validation
◦ Establishing documented evidence that provides a
high degree of assurance that a specific process will
consistently provide a product meeting its
predetermined specifications and quality attributes.
Design Qualification
◦ The documented verification that the proposed
design of the facilities, systems and equipment is
suitable for the intended purpose or documented
verification that the system design satisfies the
requirements set forth in the URS.

5. Installation Qualification
◦ The installation qualification is to demonstrate that
all the critical components of the process
equipment and support installations have been
installed appropriately and are installed to the
respective manufacturer’s or supplier’s
requirements.
Operational Qualification
◦ The OQ demonstrates whether a facility, process
equipment and sub- systems are capable of
consistently operating within established limits and
tolerances by testing compliance with design
requirements in URS.

6.  Performance Qualification
◦ Performance qualification are a collection of test
cases used to verify that the system performs as
expected under simulated real-world conditions.
◦ The documented collection of activities necessary
to demonstrate that an instrument consistently
performs according to the specifications defined by
the user and is appropriate for the intended use. A
series of tests are drawn to check the performance
of the equipment.

8.  The installation is done as per design
specification URS. (IQ)
 The operation is as per the function and
design specification in the URS. (OQ)
 The performance is as per the overall
performance requirements specified in the
URS. (PQ)
 FAT or SAT may be done based on risk
assessment or criticality.

9.  The impact of the equipment or system shall
be assessed during risk assessment to
determine those equipment or system that
requires qualification and those equipments
which do not require qualification.
 Based on risk assessment, the equipment can
be categorized as
1. Direct impact
2. Indirect impact
3. No impact

10.  Having direct impact on the product quality.
E.g. Air quality, Material of construction, type
of water, autoclave, CIP systems.
 Produces data, which is used to accept /
reject in process material or product.
E.g. Electronic Batch recording system.
 For process control systems such as PLC and
SCADA or DCS.

11.  Indirect systems are those systems whose
parts are connected to direct impact system
or are playing an important role in direct
impact systems.
E. g. labelling machine, packing machine.
 No impact systems are those having no
impact on product quality.
E.g. conveyer belts, lifting and positioning
devices.

12. category Need for Qualification
activity
Qualification approach
Direct Impact system Yes URS→DQ(FAT,SAT) →
IQ→OQ→PQ
Indirect Impact system Yes URS→DQ (FAT,SAT) →
IQ & OQ, OQ& PQ (as
applicable)
No impact system No Good Engineering
practice

13.  User Requirement specification shall be
prepared by the user department in co-
ordination with engineering based on
previous performance and practical
experience.
 URS should contain specifications of the
system, documents required, safety design
features, Equipment/ system description.
 The URS shall be approved by QA and the
same shall be submitted.

14.  After approval “Uncontrolled copy” shall be
issued by QA to Engineering dept. for the
identification of vendor who meets required
specifications.

15.  Design Qualification is aimed to specify the
equipment, system or facility is designed in
accordance with the requirements of the user
and good manufacturing practice(GMP)
standards.
 DQ document shall be prepared, reviewed by
the manufacturer. For feasibility the same
shall be reviewed and approved by the user,
Engineering and QA department.

16.  Design qualification should contain
1. Equipment/system description
2. Equipment/system technical specification
3. Review/evaluation of vendor design against the URS
4. Deficiency sheet
5. Review inclusive of follow up action (if any)
6. It should cover all the necessary diagrams and layout
7. Desired material of construction
8. Location of control panel and electrical and utility
requirement and their range.
9. After sign off, any changes made which is having
direct or indirect impact can be handled through
change control.

17.  Factory Acceptance Test is carried out by
user, Engineering/projects and QA at the site
of the vendor or by video conferencing
through FAT document provided by the
vendor.
 The evaluation includes
◦ Physical verification of dimensions
◦ Blower specifications
◦ Valves
◦ Safety requirements

18.  Critical operation requirement
◦ By simulation or conventional function
◦ Verification of documents
◦ Overall review / inspection
◦ Any modification from approved DQ, approved
during FAT shall be incorporated in CC and
considered during IQ.
◦ FAT document shall be filed in QA department.

19.  Site acceptance test shall be performed by
User, Engineering and QA at site after the
recipient of equipment/system in presence of
vendor to ensure that the equipment /
system is in good state, no components are
damaged and meeting the design as per URS.
 It involves inspection of major or sub
components in packed or unpacked
condition, alignment checks of various
components.

20.  SAT also verifies the supporting utilities,
pendants availability and adequacy etc at site.
 Points which are left out in FAT can be
assessed in SAT test.

21.  IQ document shall be prepared by
Engineering department in coordination with
user and QA.
 IQ is carried out to ensure the premises
supporting utilities and equipment have been
built and installed in compliance with their
approved design specification (DQ) and
manufacturers manual and recommendations.

22.  The documents used for IQ should contain
but not limited to
◦ Equipment description & identification
◦ List of reference documents & drawings
◦ Pre-requisites
◦ Checklist for inspection of Equipment on receipt
◦ List of Spares received
◦ Location suitability
◦ Verification of major components
◦ Verification of installation
◦ Identification of equipment / instrument for
calibration and preventive maintenance.

23. ◦ Material of construction
◦ Utilities/service connection checks
◦ Cleaning & passivation
◦ Manufacturer certificates
◦ Identification of product contact surfaces
◦ Deficiency sheet
Any non compliance observed during Installation
qualification shall be recorded.

24.  OQ shall be performed to verify that the
equipment, instrument, utility and system,
operates in accordance with design
specification, manufacturer recommendations
and cGMP requirements.
 Operational Qualification shall be prepared by
user department in coordination with
Engineering department and Quality
assurance.

25.  OQ shall be prepared based on the DQ and
manufacturers manual and recommendation.
 Operational testing to be done, whenever
possible to challenge the system, to the limits
of anticipated operating conditions.
 OQ shall be done without any load, if its not
possible then loaded trials can be taken.
 It also should test the performance of the
equipments components such as motors,
blowers, sensors, functioning of interlocks,
safety features.

26.  The OQ document should contain but not
limited to
◦ Equipment operating principle
◦ Pre-requisites for operational qualification
◦ Methodology for operational qualification
◦ Calibration review of critical instruments like
sensor, probes, gauges, recorders, air flow rates.
◦ Directions, pressure, temperature etc and referring
to standard test instrument.
◦ Operational verification of equipment i.e
operational testing as per process and system.

27. ◦ Verifications of Draft SOPs & training.
◦ Testing of safety features and interlocks
◦ Power failure verification
◦ Validation of PLC
◦ Training to personnel for maintenance and operation
◦ Deficiency sheet
◦ When OQ documents compiled by vendor the documents
shall be evaluated by the QA.
◦ The completion of successful OQ should allowed the
finalization of SOPs and cleaning procedures, operator
training and PM requirement.

28.  PQ demonstrates that how the
equipment/system will perform when
challenged under simulated or actual
production conditions.
 A series of tests are designed to demonstrate
that the equipment/system are capable to
perform consistently and meet required
specifications under routine production
operations.

29.  Performance qualification document shall be
prepared by QA (Validation) in coordination
with user department and Engineering
department.
 Performance qualification of the equipment
shall be prepared based on User’s
requirement and design qualification/
technical specification provided by the
manufacturer.

30.  PQ document should contain but not limited
to
◦ Pre-requisites for PQ
◦ Methodology for performance qualification
◦ Performance verification tests
◦ Deficiency sheet
Any significant changes it approved DQ/IQ/OQ/PQ
documents during execution should be documented
as a deviation and the same should be justified.

31.  Conditional approval for proceeding to next
phase of qualification can be given when
certain acceptance criteria or deviation is not
fully addressed, the same shall be addressed
through documented evidence of no
significant impact on the next activity.
 Qualification activities wherein location needs
to be identified for placement of data loggers
or sensors, the schematic layouts for sensor
location should be mentioned in validation
protocol for better clarity.

32.  Requalification shall be carried out in case
◦ Modification in the equipment which directly or
indirectly affects the quality of the products
processed in the equipment
◦ Relocation of the equipment
◦ Equipment up gradation
◦ Any other changes that deemed necessary for
requalification through change management
system.

33.  Guideline – SOP.com
 ICH, Q9 Quality risk management