The document discusses validation and qualification processes for equipment. It defines validation as establishing scientific evidence that a process is capable of consistently delivering quality products. Qualification is considered a subset of validation and ensures equipment is installed and will perform as intended. The key stages of validation are discussed as process design, process qualification, and continued process verification. Qualification includes design qualification, installation qualification, operational qualification, and performance qualification to demonstrate equipment is suitable for its intended use.

1. EQUIPMENT
QUALIFICATION/VALIDATION
Dr.Ajmal Nasir
Director Technical
BF Biosciences
5 km Sundar Raiwind Road
Raiwind
LAHORE
PAKISTAN

2. VALIDATION HELPS IN
Validation
Quality
Assurance
ComplianceEconomics

3. VALIDATION HISTORY
GMP include Validation
First Validation Guidance ( Equipment IQ)
New approaches/ Documents /
Presentations
New Process validation Draft Guidance
(Equipment and Analytical Validation)
New Process Validation Guidance
Issued

4. FDA 2011 GUIDANCE
•Definition VALIDATION (FDA – 2011)
• Collection and evaluation of data, from the
process design stage throughout production, which
establishes scientific evidence that a process is capable
of consistently delivering quality products.
Three stages of activities:
• Stage 1 – Process Design – Development and scale-up
activities
• Stage 2 – Process Qualification – Reproducible manufacturing
• Stage 3 – Continued Process Verification – Routine production
1987 VALIDATION -- FOCUS IS PRIMARILY STAGE 2
2011 VALIDATION -- LIFECYCLE APPROACH

5. LIFE CYCLE APPROACH
STAGE
1
•DESIGN
•UNDERSTAND
STAGE
2
•DEMONSTRATE
STAGE
3
•MONITOR
•MAINTAIN

6. QUALIFICATION &
FDA 2011 GUIDANCE
 FDA does not define QUALIFICATION.
 Qualification Considered as subset of validation,
 Performed as a larger Validation Effort or in Support to
Validation.
Equipment qualification provides documented evidence that the
subject equipment has been installed per specification (manufacturer's
recommendations) and will attain and maintain critical process
parameters repeatedly and reliably.

7. VALIDATION VS QUALIFICATION
•Validation
 Documented evidence of a process
for consistent predetermined outcome.
•QUALIFICATION
Correct Equipment / Element As per Prerequisite /
product design.
Performed on Individual Equipment or Element of
the process to be validated
Tests conducted to establish specified outcome and
verify characteristics to produce as per design.

8. PRE REQUISITES FOR VALIDATED
SYSTEMS

9. USER
REQUIREMENT
SPECIFICATION
URS
DESIGN
QUALIFICATION
D Q
INSTALLATION
QUALIFICATION
I Q
OPERATIONAL
QUALIFICATION
O Q
PERFORMANCE
QUALIFICATION
P Q
MAINTENANCE
CHANGE CONTROL
BEFORE
PURCHASE
BEFORE
USE
AFTER
USE
VENDORS
SITE
OWNERS SITE
QUALIFICATION OVERVIEW

10. QUALIFICATION STEPS
VALIDATION
TEAM
URS
RISK
ANALYSIS
EQUIPMENT
ORDERING
FAT PROTOCOLS EXECUTION
DATA
ANALYSIS
CONCLUSION
& EXECUTION
SUMMARY
EXECUTION
SUMMARY
APPROVAL
FINAL
STATUS

11. VALIDATION TEAM
Assemble the Validation / Project Team
• A multi-functional trained ,experienced team, led by a project
leader.
• Project Leader To plan and oversee the validation activities.
• Shall comprise of :
• A Team Approach Will Guarantee Well Thought Out Qualification
Processes .
• Comprehensive Protocols .
• Well Documented “Enhance Turn Over Package” Easy To Follow.

12. • Validation /Project Team Must:
VALIDATION TEAM (Contd)

13. URS
USER’S REQUIREMENT SPECIFICATIONS
•Define the intent through URS
•Must be developed By Cross functional team.

14. • We shall define in Entirety:
URS
USER’S REQUIREMENT SPECIFICATIONS
(Contd)
Sample
URS..PP
AJETT-
Granulat
orURS.d
oc

15. The risk assessment conclusion shall be part of project
validation plan, individual protocols, or any separate
document
. CONDUCT A RISK ASSESSMENT
•Essential part of all validations.
RISK ANALYSIS
RISK SAMPLE

16. BASIS FOR PROTOCOLS

17. ESSENTIAL DOCUMENTATION
STEPS

18. DESIGN QUALIFICATION
• Based on URS defined by the user and on Product Design.
• Specifications reviewed and documented by competent persons to
ensure that equipment will satisfy all the detailed specified
requirements.
• A group of qualified persons to challenge the design if built
in- house or to select OFF the Shelf equipment.
• D Q to verify that off-the-shelf equipment will fully deliver the
functionality detailed in the Design Specification(URS) , and
conform to the requirements specified GMP guidelines.

19. FINANCIAL
ANALYSIS

20. DQ
Design
Qualification
IQ
Installation
Qualification
OQ
Operational
Qualification
PQ
Performance
Qualification

21. INSTALLATION QUALIFICATION
• To Verify that:
• Correct equipment has been received, installed as per
plan and protocol.
• Equipment is complete and undamaged.
• All parts, services, controls, gauges and other
components as per requirement.
• Proper utilities connections.
• Traceable Calibration of measuring, control and
indicating devices.
• CONFIRMS Equipment materials& Finishes of surfaces.
• Out puts and Inputs are consistent to the Design.
• Equipment ,operators & materials are COMFORTABLE.
.
OBJECTIVE
To establish by objective evidence that the equipment is installed or
modified according to specifications.

22. THIS CONFIRMS THAT AFTER INSTALLATION
EQUIPMENT IS IN ORDER.
THAT THE EQUIPMENT WILL OPERATE THE
WAY IT WAS DESIGNED
INSTALLATION QUALIFICATION
Installation Qualification (IQ) Evaluates Means Of
Accommodating New Equipment And Testing Its Materials.

23. Purpose Needs for the equipment to be installed
Scope
A new equipment or already installed equipment
being installed after Modification or change.
Equipment/ System
Description
Function of the equipment , mode of operation,
process or product for, and basic design and
working principle .
Supplier
• Brief Vendor description , certification and
safety feature verification
Equipment
Components
• Brief description of major components .
• Ancillary equipment used in conjunction with
the equipment being qualified should be
identified as appropriate
SECTION REQUIREMENT/CONTENT

24. Utilities
• Utilities required to operate the equipment
should be identified.
• Supporting
Documentation
• Enlist Equipment Identification and operation
documents.
• Engineering Turnover Packages, Purchase
Orders, or Equipment Manuals
• Spare/Change
Parts
• List down spare parts and change parts.
• Identify parts through part number / Internal
code with clear definition
• Drawings
• Verified Drawings as per Design shall be part
of IQ
SECTION REQUIREMENT/CONTENT

25. Testing and
Acceptance Criteria
• Approved Acceptance criteria before
execution.
• Installation Confirmation as per Vendor
recommendation In case of deviation .
• Acceptance criteria based on proper
justification & risk analysis
• Actual Reading and supporting documents
to be part of protocol.
Discrepancies
• Discrepancies must be described and
Justified .
Summary and
Conclusion
• Summarize IQ test results,
• Demonstrate Correct Installation of the
equipment.
• Provide a conclusion to spell out Installation
acceptable or Not
SECTION REQUIREMENT/CONTENT

26. OPERATIONAL QUALIFICATION
• Verifies Equipment Operation as per Specifications.
• Challenging the Equipment Parameters.
• Verifies equipment operates according to :
• Specifications.
• Within Working range ,
• Rejection level In limits ,
• Designed output
• Designed energy consumption.
• OQ, at the very least, must include and/or address the
items in next slides
• Statistical tools should be applied to optimize
equipment and process performance.

27. SECTION REQUIREMENT/CONTENT
Purpose • State the equipment needs to be qualified
Scope
• State whether the installation is for new equipment
or modifying previous qualified equipment
Equipment/Syste
m Description
• Describe what the equipment does, how it is used,
what process/products use it, and its basic design
features
If above fully described in the IQ, then a reference to the IQ is
acceptable
SECTION REQUIREMENT/CONTENT

28. Operational
Qualification Pre-
requisites
Verify :
• All IQ tests have been completed prior to
execution of OQ
• Any Deferred IQ is identified in a protocol
and Justified as non-critical prior to OQ
testing .
Test Equipment
Calibration
Verification
• List of qualified test equipment.
• Approved materials used in protocol
execution .
• List calibration date and next due date
Standard
Operating
Procedures
Pre Approved, Implemented :
• Operating, setup and/or cleaning procedures
• Maintenance Procedures.
SECTION REQUIREMENT/CONTENT

29. Alarm/Control
Challenges
• Identify and challenge critical alarms
associated equipment/system.
• Systems integrated with other systems can be
part of other protocols and challenged
separately.
Operating
Parameters
• Define and Verify the key and critical process
parameters .
• Validate the operating ranges and acceptance
criteria for each parameter.
Rationale and
Sampling
Locations
Provide rationale for:
 Qualification approach taken
 Sample size rationale
 Selected test conditions
 Critical parameters
SECTION REQUIREMENT/CONTENT

30. Testing and
Acceptance
Criteria
• Define the test range for each critical process
parameter forValidation.
• Range shall “bracket” the operating range for
security.
• Challenge process at the extremes of the critical
process parameters wherever possible.
• Number of test runs statistically justified and
linked to the complexity of the equipment
Test Result
Documentatio
n
• Summarize test results and confirms the
acceptance criteria
Discrepancies • Discuss and justifies discrepancies
Summary and
Conclusion
• Summarize equipment OQ results and provide a
conclusion on whether the equipment operation
is acceptable
Section Requirement/Content

31. PERFORMANCE QUALIFICATION
PQ
• Verification of equipment Performance conferring to
design specifications & URS .
• Reliable and reproducible Results Under normal
production conditions in compliance to
Performance Qualification protocol.
• Shall be performed for Justified Interval, long enough
for consistent and closely controlled quality
production.
• justify the Operational Run duration or period.

32. PQ PLAN ELEMENTS
1. Purpose
2. Scope
3. Equipment Description
4. Operational Specifications
5. Acceptance Criteria
6. Testing Results
7. Discrepancies/Corrective Actions
8. Conclusions/Final Report

33. PERFORMANCE QUALIFICATION
PQ
• Performance Qualification (PQ) is performed after successful
completion of the Installation qualification (IQ) and Operational
Qualifications (OQ) .
• Performed on actual production batch size .
• Sample sizes are larger to have larger Data for analysis.
• The testing verifies that the performance specified in the Design
Specification is being delivered.
• The PQ represents the final qualification of equipment or system.
• This incorporates a range of testing to simulate process options
and provide assurance that systems and operating
documentation, are capable of subsequent process validation
activities.

34. PQ ESTABLISH AND/OR CONFIRM :
• Definition of performance criteria and test procedures.
• Selection of critical parameters, with predefined
specifications.
•
• Determination of the test intervals, e.g.,
(a) - Everyday.
(b) - Every time the system is used.
(c) - Before, between and after a series of runs.
• Define corrective actions on what to do if the system does
not meet the established criteria.
PERFORMANCE QUALIFICATION
PQ

35. P P Q ?
Process Performance Qualification
The process performance qualification (PPQ) is the second element of
Stage 2, process qualification.
The PPQ combines the actual facility, utilities, equipment (each now
qualified), and the trained personnel with the commercial manufacturing
process, control procedures, and components to produce commercial
batches.
A successful PPQ will confirm the process design and demonstrate that
the commercial manufacturing process performs as expected.
Success at this stage signals an important milestone in the product
lifecycle. A manufacturer must successfully complete PPQ before
commencing commercial distribution of the drug product.16 The decision to
begin commercial distribution should be supported by data from
commercial-scale batches. Data from laboratory and pilot studies can
provide additional assurance that the commercial manufacturing process
performs as expected.

36. Except regulatory requirements regarding time specific intervals for periodic
re-qualification, a validation assessment to be completed for each change to
determine and document for no potential validation impact and the validation
status is maintained, including the possibility of requalification.
Requalification Review
The validation status of qualified equipment must be reviewed to
determine whether it continues to operate in A qualified state.
Change control determines requalification requirements to
maintain the validated state.

37. RE QUALIFICATION
Required if Change in:
- Batch size (significant)
- Operating parameters
- Component / Materials specifications
- New accessories or components are added to a
qualified equipment
- Process changes that potentially can effect Quality

39. PROTOCOL EXAMPLES
WHO
ISPE

40. THANKS
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