The document outlines the systematic approach of validation and qualification processes in manufacturing, focusing on ensuring equipment operates within specified parameters to consistently produce quality results. It details various stages like design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), each addressing different aspects of verifying equipment functionality and compliance with good manufacturing practices. The main objective is to maintain product quality and operational reliability, suggesting that smaller labs may consider external validation services for effective compliance.

1. ANUSIKTA GHOSH
18MPH102

2.  Validation is a systematic approach to collecting and
analyzing sufficient data to give reasonable assurance
and documented evidence that a process or an
analytical method will, when operated within specified
parameters will consistently produce results within
predetermined specifications.
 When this approach is related to a machine or
equipment rather than Validation this is referred to as
Qualification.

3.  Qualification is part of, but not limited to a validation
process, which in turn can be divided into
 Design Qualification(DQ)
 Installation Qualification (IQ)
 Operational Qualification (OQ)
 Performance Qualification(PQ)

4.  The Design Qualification is focused on ensuring there
is documented verification that the proposed design is
suitable for the intended purpose. The first element of
a Validation effort should be the Design
Qualification(DQ). Where applicable the compliance of
the design with Good Manufacturing Practice should
be demonstrated and documented.
 The Design Qualification is the only document that is
going to confirm that the design will work. It must be
authored and executed by suitably qualified persons
who are knowledgeable enough to challenge the
proposed design and its performance.

5.  A Design Validation Protocol can also be used where a
Company has prepared a User Requirements
Specification (URS) for a piece of equipment & is
searching for a manufacturer but is offered off The
Shelf. A Design Validation Protocol can be used to
verify whether the Off The Shelf item will fully deliver
the functionality detailed in the URS & confirm to the
requirements specified in the VMP/cGMP while
complying with all applicable Health & Safety notices.

6.  The scope of Design Validation Protocol must include
but is not limited to:-
 Verification that the design will achieve the URS
requirements.
 Verification that the design is cGMP compliant &
where software is used conforms to the life cycle model
requested in the VP.
 Verification that the design complies with the VMP.
 Verification that the utility services required are
available and validated.
 Verification that all the required support
documentation is specified.

7.  Verification that the system will be calibratable.
 Verification that the system will be maintainable.
 Verification of operation staff training requirements.
 Verification that the system will operate in a manner
safe to both product & staff.
 Verification that the system conforms to all applicable
National Standards & Guidelines.

8.  Any new equipment is first validated to check if it is capable
of producing the desired results through Design
Qualification(DQ), but its performance in a real world
scenario depends on the installation procedure that is
followed.
 Installation Qualification (IQ) verifies that the instrument or
equipment being qualified, as well as its sub systems & any
ancillary systems, have been delivered, installed &
configured in accordance with the manufacturer’s
specifications or installation checklist.
 In addition to this any cGMP requirements that pertain to
the IQ & the approach used for IQ is thoroughly
documented in the Validation Master Plan(VMP).

9.  For successful qualification the installation must meet
manufacturer requirements like:
 Installation location & floor space
 Power, gas supply & other energy sources
 Environmental & operating conditions
 Unpacking instruments and checking for damage
 Cross- checking contents against the packaging list
 Documentation of computer controlled instrumentation
 Checking software –installation & basic accessibility
 Installation ancillary instruments & other options
 Verifying connections & communication with peripheral
units.

10.  Recording firmware versions & serial numbers
 Tagging instruments with IQ stickers
 Recording calibration and dates of equipment used for
IQ
 Gathering all manuals & certificates of conformity.

11.  Once each protocol of the IQ phase has been met,
Operational Qualification (OQ) is performed to check that
the equipment;s performance is consistent with the User
Requirements Specification (URS),within the manufacturer
specified operating ranges.
 During the OQ phase, all the items in the test plan are tested
individually & their performance documented. This is a
prerequisite for technical acceptance of the equipment & the
facility,so it can only be performed once the Iq has been
successful.
 A part from qualification after the initial installation
requalification also needs to be carried out after any major
maintenance work or modifications have been made to
equipmet,or as a part of regular quality assurance schedule.

12.  The main purpose of OQ is to identify & inspect features of
the equipment that can influence final product quality like:
 Display units &signaling LEDs
 Temperature controls & fluctuations
 Overheating & low temperature protection systems &
alarms
 Pressure/vacuum controlling systems
 CO2 controlling systems
 Humidity measuring & controlling systems
 Fan & fan speed controllers
 Servo motors & air flap controllers
 Card readers & access contollers
 Temperature distribution in accordance with DIN
12880:2007-05

13.  Performance Qualification is the final step in qualification
processes for equipments & this step involves verifying &
documenting that the equipment is working reproducibly
within a specified working range.
 Rather than testing each instrument individually , they all
are tested together as part of a partial or overall process.
 Before the qualification begins, a detailed test plan is
created, based on the process description.
 Process Performance Qualification (PQ) protocol is a vital
part of process validation & qualification, which is used to
ensure ongoing product quality by documenting
performance over a period of time for a certain process.

14.  FDA Guidelines recommend including the following criteria
as part of PQ & PPQ protocols:
 Manufacturing conditions like equipment limits, operating
parameters & component inputs.
 A list of the data that should be recorded or analyzed
during tests, calibration & validation
 Tests that need to be performed to ensure persistent quality
at various steps of production
 A sampling plan which outlines the sampling methods used
during & in between production batches
 Analysis methodology for making data scientific & risk
oriented decisions based on statistical data
 Defining variability limits & contingency plans for handling
non conformance.
 Approval of the PPQ protocol by relevant departments.

15.  Equipment qualification through DQ,IQ,OQ,PQ
practices is a part of Good Manufacturing
Practice(GMP),through which manufacturers &
laboratories can ensure that their equipment delivers
consistent quality.
 It reduces the margin for errors, so the product quality
can be maintained within the industry standards or
Regulatory Authority Requirements .
 When qualification of equipment is not needed very
frequently, performing it in-house might not be
feasible, so smaller laboratories might benefit from
scheduling external equipment validation services on a
regular basis instead.

16. THANK YOU.