This document discusses equipment qualification and provides details on the key aspects: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It defines these qualification types and describes their objectives. For example, DQ defines functional specifications, IQ verifies correct installation, OQ demonstrates functions work as specified, and PQ ensures consistent performance under normal operating conditions. The document also discusses applying these qualifications to dissolution test apparatus to ensure quality and regulatory compliance. It stresses the importance of documentation systems for locating documents quickly.

1. BY: HEMLATA R. MORE
ASSISTANT PROFESSOR
QUALITY ASSURANCE

2. CONTENT ::
Definition
Objectives And Goals
Equipment Qualification :
DQ ( Design Qualification )
IQ ( Installation Qualification )
OQ (Operation Qualification )
PQ ( Performance Qualification )
Qualification Of Equipment
Documentation System

3. Definitions :
 Equipment : It is the collective analytical
measurement instruments , assembled to perform a
mechanical process .
 Equipment Qualification : It is the action of
proving that any equipment works correctly and
actually leads to accurate and reliable results .
 Qualification : Is the process to assure something
complies with some condition , standard , or specific
requirements .

4. Objectives And Goals
Easy maintenance of equipment and safety
To improve overall production reliability
and availability
Control of product quality
Reduction of variation in result
Fewer interruption of work
Lower repair costs
Identification of high maintenance cost

5. Equipment Qualification
 Design Qualification ( DQ ) : It defines the functional and
operational specifications of the instrument and details for the
conscious decisions in the selection of the supplier .
 Step that should be considered in a design
qualification :
• Description of the analysis problem
• Description of the intended use of the equipment
• Description of the intended environment
• Instrument test
• Final selection of the equipment

6. Installation Qualification ( IQ )
The performance end documentation of tests to ensure that equipment (
such as machines , measuring equipment ) use in a manufacturing
process are appropriately selected , correctly installed and work in
accordance with established specifications.
 Aim :
• To check documentation against reality
• Verifies that the equipments are installed in accordance with design
specification , manufacturer recommendation and cGMP’s
• Confirms that critical instruments are calibrated
• Pre-shipment inspection can be performed along with vendors audit to
address issue such as software development and quality assurance plan
,operational reports
• Vendors inspection report

7. Operational Qualification (OQ)
 Operational qualification is the process of demonstrating
that an instrument will function according to its operational
specification in the selected environment within the
acceptance criteria .
 The protocol must contain procedures to start up the
equipment to the operating manuals.
 Process control that are part of the equipment i.e.
Programmable Logic Controller (PLC) will be qualified
during the OQ .
 OQ implies that all functions and features included with the
system are operational .

8. Cont……
 SOP for use , maintenance , calibration and cleaning of the
plant must be developed during the OQ process , as well as
schedules for maintenance and calibration .
 Any failure in this qualification is a deviation and must be
corrected.
 A conclusion is drawn regarding the operation of equipment
after the test functions are checked and all data has been
analyzed.

9. Performance Qualification ( PQ )
 PQ is the process of demonstrating that an instrument or
peace of equipment consistently performs according to a
specification appropriate for its routine use .
 PQ should always be performed under condition that are
similar to routine sample analysis.
 PQ should be performed on a daily basis or whenever the
equipment is being use .
 In practice, PQ can mean system suitability testing ,where
critical key system performance characteristics are
measured and compared with documented.

10. Qualification Of Dissolution Test Apparatus

11. Need Of Dissolution Testing
 To ensure continuity of product quality and
performance of manufacturing process .
 Requirement for regulatory approval for product
marketing .

12. Qualification
 To ensure that equipment is fit for intended purpose
, there are no. of qualifying steps that vendors /
analyst should apply to analytical instruments .
 Equipment is evaluated through these tests and
successful completion justifies instrument operates
and performs .

13. Design Qualification
When developing dissolution method DQ is built into
apparatus selection of process , Dosage form and delivery
system will determine choice of equipment.
Installation Qualification
Use to verify that instrument has assembled in the
appropriate environment and its functioning according to
predefined of limit .

14. Operational Qualification
During this qualification analyst or vendor assess that
equipment works as specified and generates documented
data.
Performance Qualification
This conducted to ensure that system is in normal operating
environment and performing designed set of tasks within
specifications

15. Documentation System
 To quickly locate any given document , it is
mandatory to have implemented an appropriate
documentation system .
 In case of a fault in production inspection , it become
necessary to find a document within 15 to 20 min .
 All companies should test the reliability of their
documentation system using internal audits .
 One aspect of working documented using the same
document maintenance structure

16. THANK YOU !