Pharmaceutical Equipment Validation

1. Presented by:
Swati Swagatika Swain
Regd no- RA212225401006
Department of Pharmaceutics
M. Pharm 1st yr
SRM College of Pharmacy

2. OUTLINES
 Introduction
 Validation study phase
 Parts of equipment validation
 Aim of equipment validation
 Roles of FDA in equipment validation
 Dissolution apparatus validation
 References
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3. VALIDATION
 Definition:
 Validation is the documented act of proving that any
procedure, process, equipment, material, activity or
system showing the correct result or not.
Objective of validation:
It reduces the risk of regulatory non-compliance.
Reduction of time to the market for the new products.
It will increase productivity in lower cost.
Reduces the chances of product re- call from market.
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4. TYPES OF VALIDATION
• It is a process to validate the reproducibility and
consistency of the process.
Process
validation
• Procedure is used to check if a equipment is
properly calibrated ,maintained or not.
Equipment
validation
• Procedure used to ensure that the cleaning
process has eliminated the residues of drug
substance from equipment surface after
manufacturing.
Cleaning
validation
• It consist of documenting the quality of
analytical procedure.
Analytical
method
validation
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5. INTRODUCTION
 It is a regulatory requirement for pharmaceutical
companies to perform instrument validation on all
new equipment.
 Equipment validation requires detailed knowledge of
the instrumentation system being validated and is
therefore performed by company supplying the
equipment.
 It gives the assurance that the equipment works
properly and giving accurate result.
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6. VALIDATION STUDY PHASE
• Pre-validation
Phase
• Other name:
Qualification
Phase
Phase-1
• Process Validation
• Other Name:
Process
Qualification
Phase
Phase-2 • Validation
Maintenance Phase
Phase-3
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7. PARTS OF EQUIPMENT
VALIDATION
Equipment
Validation
Installation
qualification(IQ)
Operational
qualification
(OQ)
Performance
qualification
(PQ)
Design
qualification
(DQ)
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8. Principle of Equipment
Validation
Designed
Constructed
Adapted
Maintained
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To perform the
operations which are
to be carried out.

9. Aim of Equipment Layout and
Design
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To minimize
the risk of
errors
To permit
effective
cleaning and
maintenance
To avoid Cross
contamination
and dirt, dust
build up
To avoid any
adverse effect
on quality of
products

10. Design qualification
 It provides documented verification that the design of
new instrument or equipment will result in a system
that is suitable for the intended purpose.
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• Analytical Problem
• Use of Equipment
• Environment
• Function and
performance
What are to
be
Considered?

11. INSTALLATION
QUALIFICATION
 It tells whether the equipment is properly installed
and whether it is suitable for that environment.
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Support
Group
Equipment
Management
Group
Plant
Engineering
Group

12. Documented Records for
Installation
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Installation
Qualification report
includes
The Supplier and the
manufacturer
System or Equipment
Name
Model and Serial Number
Date of Installation

13. Contd...
Installation Qualification Includes:
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Inspection
Checklist
Installation
Checklist

14. Inspection Checklist
Instructions Explains how this section is physically executed
Table of Contents Lists the major components of an equipment
Specification Explains manufacturers specifications
Actual Things that are actually observed are listed here
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15. Installation Checklist
 This section of protocol determines whether or not a
piece of the equipment or system as a whole meets the
manufacturer’s design specifications.
 It is recorded as “Yes” or “No”.
 If “No”s are then recorded as deviations or deficiencies.
 Environmental Requirements: Specifically
considers humidity, temperature of a particular piece
of the equipment.
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16. Operational Qualification
 It demonstrates that an instrument will function
according to its operational qualification in the
selected environment within the acceptance criteria.
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Start up of
Equipment
according to
the manual
Programm
able Logic
Controller
(PLC)
All
Functions
and features
are
Operational
SOP,
Maintenance
and
Calibration
Report
Generation
and Data
Analysis

17. Contd...
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Application
SOPs
Utilization
List
Process
Description
Critical
Parameters
Test
Function
List
Test
Function
Summary
Test
Instrument
Details
Test
Instrument
Calibration
Contents

18. Contd...
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List the necessary
test instruments
before starting the
test the instrument
is to be calibrated
and maintained till
the completion of
the test.
Alarm testing
Operation Testing
Test Equipment Test Procedure

19. Performance Qualification
 Performance Qualification : The final selection for
equipment qualification protocols.
 A process of demonstrating that an instrument or
piece of equipment consistently performs according to
a specification for it routine use.
 The factors like Loads, Volumes, Capacity and Power
related issues should not be problematic throughout
the specified range.
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20. Documentation System
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Working
Documentation
System
Documentation
of Inspection
Documentation
of Internal
Audit
Documentation
For quick location of
document
In case of fault in
production
For reliability on
documentation

21. Contd...
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List any test
instrument
necessary and must
be calibrated prior to
use and till the
process complete.
This is the final
phase of validation
process.
Test Equipment

22. Roles of FDA in Equipment
Validation
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Validation Process
Regulated by
CFR : Code of Federal
Regulation (US Govt.)
for food and drugs
Guidelines and
regulations set forth by
the FDA
Validation Rules as per
21 CFR Part 210 and 211

23. Testing Procedure
 Table of Contents
 List of standardised sections
 Unique testing procedure
 Approval Page
 Preapproval Selection
 Final approval Selection
 Description
 Statement of purpose
 Standard Operating Procedure
 Calibration
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24. Examples of Equipment
Validation
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Validation of
Autoclave
Validation of
Ethylene Oxide
Sterilisation System
Validation of
Radiation Sterilisation
Method
Validation of
Filters
Validation of
Dissolution Apparatus

25. Validation of Autoclave
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26. Validation of Dissolution
Apparatus
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28. Validation of Dissolution Test
Apparatus
 To have a high degree of assurance dissolution
apparatus should be consistent and accurate in its
performance.
 Therefore validation of this equipment is required.
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29. Design Qualification of
Dissolution Apparatus
 When developing dissolution
method design qualification is
built into apparatus selection of
process.
 Dosage form delivery system will
determine choice of equipment.
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Example: First choice for beaded product may be
USP app 3... As it is designed to consign beads in a
screened in cylinder.

30. Installation Qualification of
Dissolution Apparatus
 Used to verify that instrument has
assembled in the appropriate
environment and its functioning
according to predetermined set of
limit.
 Example: Setting of fully automated
dissolution testing apparatus
requires proper plumbing hot water,
source stable bench top.
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31. Operational Qualification of
Dissolution Apparatus
 During this qualification, analyst or
vendor assess that equipment works as
specified and generates the documented
data.
 Example: For dissolution water bath
temperature, Shaft RPM.
 Speed would be operational parameters.
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32. Performance Qualification of
Dissolution Apparatus
 This is conducted to ensure that the system is in
normal, operating environment and performing
designed set of tasks within the specification.
 Example: Centering, Wobble, Height of paddle or
basket to shaft, speed, temperature.
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33. Reference
 Pharmaceutical quality assurance by Manohar A.
Potdar, Nirali Prakashan, CBS Publishers
 Equipment and its validation by Nash.
 http://pharmatech.com
 www.slideshare.net
 www.wikipedia.com
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