The document outlines the qualification process for various pharmaceutical manufacturing equipment, including dry powder mixers, fluid bed dryers, capsule filling machines, and tablet compression machines. It details the four phases of qualification: design, installation, operational, and performance, emphasizing the importance of ensuring that equipment meets specifications and functions correctly. The conclusion highlights the necessity of maintaining product quality and purity through rigorous evaluation by quality assurance.

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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