it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)

1. PRESENTED BY:
Mr. Ankush P. Jadhav & Miss. Tejashree R. Kedar
M. Pharm (PQA)
Email id: jadhavbrand@gmail.com,
.............tejashrikedar@gmail.com
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QUALIFICATION OF MANUFACTURING EQUIPMENTS

2. QUALIFICATION OF MANUFACTURING
EQUIPMENTS
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3. CONTENTS
• INTRODUCTION
• DRY POWDER MIXER
• FLUID BED DRYER
• CAPSULE FILLING MACHINE
• TABLET COMPRESSION MACHINE
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4. INTRODUCTION
QUALIFICATION
• “It may be defined as the action of providing and documenting that equipment or
ancillary systems are properly installed, work correctly, and actually lead to the
expected results.”
• Qualification is the part of validation.
• Qualification have been grouped into four phases of qualification.
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5. DESIGN QUALIFICATION
• Design qualification (DQ) defines the functional and operational specifications of
the equipment.
INSTALLATION QUALIFICATION
• The IQ process is intended to demonstrate that equipment meet all Specification,
installed properly and supporting program ( SOP, Maintenance sheet)
are in place.
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6. OPERATIONAL QUALIFICATION
• OQ is the process of demonstrating that an instrument will function according to
its operational specification in selected environment.
PERFORMANCE QUALIFICATION
• It refers to establishing by objective evidence that the process consistently
produces a product which meets all predetermined requirements.
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7. 1) DRY POWDER MIXER
DESIGN QUALIFICATION (DQ)
• Design qualification (DQ) defines the functional and operational specifications of
the instrument.
Design qualification Of it includes :
• Facility layout, Utility requirements and specifications.
• Required capacity of the Mixer.
• Type of materials to be mixed, Mixing time
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8. INSTALLATION QUALIFICATION (IQ)
• The IQ process is intended to demonstrate that the Dry Powder Mixer meet all
specification, installed properly and supporting program ( SOP, Maintenance sheet )
are in place.
The IQ includes following checks :
• Supplier or manufacturer name & address shall be checked.
• Equipment name, make & model no. shall be noted down.
• Check Gear Box, Control Panel, Buttons, Driving Motor 8

9. OPERATIONAL QUALIFICATION (OQ)
• OQ is the process of demonstrating that an instrument will function according to
its operational specification in selected environment.
OQ includes following checks :
• On/ off Switch
• Gross Capacity
• RPM
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10. PERFORMANCE QUALIFICATION (PQ)
• Load the material into the mixer
• Start the mixer and rotate it for the time as mentioned in the BMR
• After completion of mixing switch off the mixer & Separate out material
• Collect the sample as per sampling procedure
• Send the samples to QC departmnet for Content Uniformity, Bulk Density & Sieve
analysis
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11. 2) FLUID BED DRYERS
DESIGN QUALIFICATION (DQ)
It Involves the Functional & Operational Specification of Dryers
• Facility Layout
• Utility Requirement i.e. Vertical or Horizontal
• Required Capacity Of The Dryer
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12. INSTALLATION QUALIFICATION (IQ)
• Equipment Should Comply With The Original Purchase Specification
• Utility Installation, Operating Manual
• Check for any physical damage
• Verify electrical Supply
• Inlet Air installation
• SOP, Mfg. / Supplier Details
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13. OPERATIONAL QUALIFICATION (OQ)
• Check Alarm control
• Speed Of Air
• Moisture Content
• Tap Density
• Particle Size Distribution
• Heat Distribution study
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14. PERFORMANCE QUALIFICATION (PQ)
• The system is installed with Design specification, Mfg. Recommandations &
cGMPs.
• Run The Trial batch during operation and there should not be change in the Size,
Shape, Surface Characteristics.
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15. 3) CAPSULE FILLING MACHINE
INSTALLATION QUALIFICATION (IQ)
The Installation Qualification will confirm details :
• The engineering specifications
• cGMP guidelines and requirements
• The purchase order no. & date shall be checked
• The accessories & their spare parts if any shall be checked as per purchase order
• Equipment name, make & model no. shall be recorded
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16. OPERATIONAL QUALIFICATION (OQ)
• Before initiating OQ ensure that SOP for operation and Cleaning of Capsule
Filling Machine is available.
• The operation of indicators, controls and alarms is verified
• Oil leaks that could contaminate the process are observed
• Check the capsule filler to the required specifications
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17. PERFORMANCE QUALIFICATION(PQ)
• PQ activities demonstrates and documents that the equipment is able to perform its
intended functions.
• To ensure that the quality and purity of the product is maintained
• Record the number of damaged capsules
• Capsules should be tested for weight uniformity
• Capsules batches should be tested for content uniformity
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18. 4) TABLET COMPRESSION MACHINE
INSTALLATION QUALIFICATION (IQ)
The Installation Qualification Will Confirm Details :
• Model Number
• Serial Number
• Location Of The Equipment
• The Accessories & Their Spare Parts Checked As Per Purchase Order
• Any Deviation Observed Should Be Informed To The Supplier/Manufacturer
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19. OPERATIONAL QUALIFICATION (OQ)
Equipment Can Operate With Specified Limits
• Upper Punch Test
• Lower Punch Test
• Tablet Press Speed
• Tablet Press Rotation Direction
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20. PERFORMANCE QUALIFICATION(PQ)
• PQ activities demonstrates and documents that the equipment is able to perform its
intended functions.
• To ensure that the quality and purity of the product is maintained
• Record the number of damaged tablets
• Tablet should be tested for weight uniformity, Hardness test
• Tablet batches should be tested for content uniformity
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21. CONCLUSION
• Evidence that equipment operates consistently within established limits.
• To ensure that the quality and purity of the product is maintained.
• Performed in stages : Design, Installation, Operation, Performance,
Requalification
• Information evaluated independently by Quality Assurance.
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22. REFERENCE
• Berry I.R., and Nash R.A., “Pharmaceutical Process validation” second edition,
revised and expanded; Marcel Dekker series; 83-110.
• Equipment Qualification & Validation of Autoclave, Dry Heat Sterilization And
Membrane Filtration.
• Manohar A. Potdar “Pharmaceutical Quality Assurance” Nirali Publications, 6th
edition, 2017.
• Sawant R., Hapse S., “Fundamentals of Quality Assurance Techniques” 2nd
edition, Career Publications, May 2016.
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23. THANK YOU…
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