Validation essentials for pharmaceutical manufacturing

Prepared by
Shivam Thakore
Ankit Patel
Harsh Oja

Guided by
Mr. Nihar Shah
Associate professor
LJIP, Ahmedabd

Department of Pharmaceutical Technology,
4/16/2013 LJ institute of Pharmacy,Ahmedabad 1

What is Validation?
 According to FDA, validation is method to
establish documented evidence which provides a
high degree of assurance that specific process
will consistently produce a product meeting its
predetermined specification and quality
attributes.
 It is a quantitative approach needed to prove
quality, functionality and performance of
pharmaceutical manufacturing process. It is
very broad term.
 It will apply to individual parts of
pharmaceutical equipment and also to the
pharmaceutical process as a whole.

 According to WHO, Validation is the collection
and evaluation of data, beginning at the process
development stage and continuing through the
production phase, which ensure that the
manufacturing processes - including
equipment, buildings, personnel and materials -
are capable of achieving the intended results on
a consistent and continuous basis.


Related terms…
 Validation: Usually applies to a process. It is
the overall action of proving, in accordance with
the principles of GMP, that any process,
equipment, material, activity or system actually
results in a test or process that will perform as
the user has specified.
 Qualification: Usually applies to equipment. It
is the stepwise action of proving that any
particular premises, systems and/or piece of
equipment will actually lead to the expected
results
 (Qualification is a part of validation. Validation will
include other parts such as SOPs for all the operations
associated with the equipment and training on the use
of the equipment).


Qualification (Equipment validation)
 It is performed to ensure that equipment
produces consistent results with minimal
variation without compromising the integrity of
the product and the persons operating the
equipment.
 It is performed to establish confidence that
process equipment and ancillary systems are
capable of consistently operating within
established limits & tolerance.
 It is generally divided into five parts of
qualification.


Various phases of
Qualification
 Design Qualification (DQ)
 Installation Qualification (IQ)
 Operational Qualification (OQ)
 Performance Qualification (PQ)
 Requalification (RQ)


Design Qualification (DQ)
 Basically is presets the specification required for the
equipment.
 It defines the functional and operational
specifications of instrument & details for the
conscious decisions in the selection of the supplier.
 It is performed prior to the equipment purchase and
describes the features required for the equipment to
installation.
 The Design Qualification is the only document that
is going to confirm that the design will work. It must
be carried out by Qualified people who can challenge
the design performance.


Key Considerations
 Equipment capabilities:
 Speed
 Capacity
 Temperature
 Requirements:
 Voltage
 Size limitation
 Operational specifications
 Features:
 Self Calibrating
 Service Contracts


List of steps to be included in
DQ
 Description of analysis problem
 Description of intended use of the equipment, its
environment.
 Preliminary selection of the functional and
performance specifications.
 Supplier selection.
 Final selection of equipment.
 Final selection of supplier and equipment.
 Development & documentations of specifications

4/16/2013 Department of Pharmaceutical Technology,
LJ institute of Pharmacy,Ahmedabad 10

 It generally indicates the requirements that the
equipments must meet in order to work specifically.
 FOR EXAMPLE
 Equipment description eg A500/540/560 Automatic
Centrifuge
 Specification
 Reasons for selection of this model
 Electrical requirements/ losses
 Tolerance/performance
 Maintenance/Cleaning
 Other

 Person responsible for this selection


Installation Qualification
 Installation Qualification (IQ) execution verifies that
the equipment and its ancillary systems or sub-
systems are present and have been installed in
accordance with installation drawings and or
specifications.
 It established that the instrument is received as
designed and specified, that it properly installed in
the selected environment & this enviroment is
suitable for the operation and use of instrument.
 It requires the team effort by
 The vendor
 The operating department
 The project team


 IQ should be performed on all new or modified
facilities, systems and equipments.
 FDA states that “IQ includes examination of
equipment design; determination of calibrations,
maintenance and adjustment requirements; &
identifying critical equipment features that
could affect the process and product,
Information obtained from these studies should
be used to establish SOP’s covering equpiment
calibrations, maintenance, monitoring and
control ”


Key Considerations
 All unit operations are installed as per
specifications & design drawing.
 Support systems like instrument calibration
programs, preventive maintenance procedures
& obeying SOP’s are addressed.
 Verification that established specification have
been complied during construction &
installation.
 Verification of construction
materials, examination and documentation of
welds.
 Inspection for dead legs, pipe slopes.
 Verification of SS pasivation.

 Verify that the equipment complies with
National electrical codes
 Verify that all alarms and visual displays are
operational and correct.
 Verify that if appropriate, the correct versions of
software are used.
 Identify and verify that serial numbers and
model number of all equipment or component
parts is as listed in the installation
documentation.
 Review all calibration certificates for the
equipment.
 Verify that the ambient conditions are
appropriate for the operation of the equipment.


Also following has to be
checked
 Delivery date?
 Manual received? (hardcopy/Electronic format)
 Location for installation
 Name of installer.
 Power up worked? (Y/N)
 Self checked passed? (Y/N)
 Service/ Calibration plans established(Details)
 Other


Ensure
voltages are
correct.
Ensure
power is
supplied to
all
equipment.
Verify
operation of
lights and
display.
Ensure
floor loading
is even.

Operational Qualification
 The QO is a process of demonstrating that an
instrument will function according to its
operational specification in the selected
environment.
 includes a review of the operating manual and
verification that all functional aspects of the
equipment are performing as intended
throughout all anticipated operating ranges.
(This is a good time to start writing the SOPs
pertaining to the equipment.)


Key Considerations
 Testing of alarms.
 Testing of interlocks and permissive conditions.
 Testing of database or data storage integrity.
 Verification & review of the functionality of the
equipment with GMP regulations.
 Challenge of software, where required;
 Testing of security levels to prevent
unauthorized access;
 Testing to verify and document Power loss
Recovery.
 Testing of all interfaces between separate pieces
of equipment.
 Testing for Electromagnetic interference and
compatibility.

Also…
 Describe the specification to be tested.
 Drying temperature, Paddle/basket rpm
 Accuracy of all the specification
 Has equipment been calibrated?
 By whom (attached documented evidence)
 Has an SOP been written?
 If not then do it right now before usage of equipment.
 Process description
 Details of process
 Study critical parameters.
 Temperature, chopper, baffles etc


 Operational Qualification is
essentially acceptance testing
and should serve as the basis
for final payment.

 So imagine the importance of
this step…


Performance Qualification
(PQ)
 PQ is the process of demonstrating that an
instrument consistently performs according to
the specification appropriate for its routine use.
 PQ is performed after successful completion of
the IQ & OQ.
 The testing verifies that the performance
specified in the Design Specification is being
delivered.


Key considerations
 It should be performed under conditions that are
similar to routine sample analysis.
 PQ should be performed on the daily basis or
whenever the equipment is being used.
 Generally, PQ can mean suitable testing of
equipment, where critical key system parameters are
measured and compared with documented preset
limits.
 Definition of performance criteria and test
procedures.
 Determination of the test intervals.
 Everyday
 Every time the system is used
 Before, between, after series of runs

 Once the validation team has completed all the
steps (DQ,IQ,OQ,PQ) of equipment, the
equipment is said to be validated.
 Validation individual will circulate the
completed documents for final comments and
approval. Any comments or correction by the
sign off committee will be followed by validation
individual.
 Once the documents are signed off, the
validation individual will transfer all documents
to operating department of the equipment.


Requalification (RQ)


References
 Parikh R K, Makwana Vijay, “Validation of
pharmaceutical process” LM college of
Pharmacy,Ahmedabad.
 www.ncsu.edu/checs/media/Validation_Tutorial.p
pt/ accesed at 15th April 2013
 www.gmpsop.com/.../val-
090_equipment_validation_guideline_sam.../
accesed at 15th April 2013
 www.askaboutvalidation.com/.../forumdisplay.php
?...EQUIPMENT-.../ acessed at 15th April 2013
 www.pharmout.com.au/services/validation/equip
ment-validation.shtml/accesed at 15th April 2013


Validation essentials for pharmaceutical manufacturing

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