EQUIPMENT

QUALIFICATION/VALIDATION

Dr.Ajmal Nasir
Director Technical
BF Biosciences
5 km Sundar Raiwind Road
Raiwind
LAHORE
PAKISTAN
VALIDATION HELPS IN

Quality
Assurance

Validation

Economics Compliance
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New Process validation Draft Guidance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
 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

 LIFE CYCLE APPROACH

•DESIGN
STAGE •UNDERSTAND
1

•DEMONSTRATE
STAGE
2
•MONITOR
STAGE •MAINTAIN
3
 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.
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.
PRE REQUISITES FOR VALIDATED
SYSTEMS
 QUALIFICATION OVERVIEW
VENDORS OWNERS SITE
SITE

BEFORE BEFORE AFTER

PURCHASE USE USE

USER
DESIGN INSTALLATION OPERATIONAL PERFORMANCE
REQUIREMENT
QUALIFICATION QUALIFICATION QUALIFICATION QUALIFICATION
SPECIFICATION MAINTENANCE
URS DQ IQ OQ PQ

CHANGE CONTROL
 QUALIFICATION STEPS

VALIDATION RISK EQUIPMENT

URS
TEAM ANALYSIS ORDERING

DATA
FAT PROTOCOLS EXECUTION
ANALYSIS

CONCLUSION EXECUTION
FINAL
& EXECUTION SUMMARY
STATUS
SUMMARY APPROVAL
 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.
 VALIDATION TEAM (Contd)
• Validation /Project Team Must:
 URS
USER’S REQUIREMENT SPECIFICATIONS

• Define the intent through URS

• Must be developed By Cross functional team.
 URS
USER’S REQUIREMENT SPECIFICATIONS
(Contd)

• We shall define in Entirety:

Sample
URS..\PP
A\JETT-
Granulat
orURS.d
oc
 RISK ANALYSIS
. CONDUCT A RISK ASSESSMENT
• Essential part of all validations.

The risk assessment conclusion shall be part of project

validation plan, individual protocols, or any separate
RISK SAMPLE document
BASIS FOR PROTOCOLS
ESSENTIAL DOCUMENTATION
STEPS
 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.
FINANCIAL
ANALYSIS
 DQ IQ
Design Installation
Qualification Qualification

PQ OQ
Performance Operational
Qualification Qualification
 INSTALLATION QUALIFICATION
OBJECTIVE
To establish by objective evidence that the equipment is installed or
modified according to specifications.
• 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.
.
 INSTALLATION QUALIFICATION
Installation Qualification (IQ) Evaluates Means Of
Accommodating New Equipment And Testing Its Materials.

THIS CONFIRMS THAT AFTER INSTALLATION

EQUIPMENT IS IN ORDER.

THAT THE EQUIPMENT WILL OPERATE THE

WAY IT WAS DESIGNED
 SECTION REQUIREMENT/CONTENT

Purpose Needs for the equipment to be installed

A new equipment or already installed equipment

Scope
being installed after Modification or change.

Function of the equipment , mode of operation,

Equipment/ System
process or product for, and basic design and
Description
working principle .

• Brief Vendor description , certification and

Supplier
safety feature verification

• Brief description of major components .

Equipment • Ancillary equipment used in conjunction with
Components the equipment being qualified should be
identified as appropriate
 SECTION REQUIREMENT/CONTENT

• Utilities required to operate the equipment

Utilities
should be identified.

• Enlist Equipment Identification and operation

• Supporting documents.
Documentation • Engineering Turnover Packages, Purchase
Orders, or Equipment Manuals

• List down spare parts and change parts.

• Spare/Change
• Identify parts through part number / Internal
Parts
code with clear definition

• Verified Drawings as per Design shall be part

• Drawings
of IQ
 SECTION REQUIREMENT/CONTENT

• Approved Acceptance criteria before

execution.
• Installation Confirmation as per Vendor
Testing and recommendation In case of deviation .
Acceptance Criteria • 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 .
• Summarize IQ test results,
• Demonstrate Correct Installation of the
Summary and
equipment.
Conclusion
• Provide a conclusion to spell out Installation
acceptable or Not
 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.
 SECTION REQUIREMENT/CONTENT

Purpose • State the equipment needs to be qualified

• State whether the installation is for new equipment

Scope
or modifying previous qualified equipment

• Describe what the equipment does, how it is used,

Equipment/Syste
what process/products use it, and its basic design
m Description
features

If above fully described in the IQ, then a reference to the IQ is

acceptable
 SECTION REQUIREMENT/CONTENT
Verify :
• All IQ tests have been completed prior to
Operational
execution of OQ
Qualification Pre-
• Any Deferred IQ is identified in a protocol
requisites
and Justified as non-critical prior to OQ
testing .

• List of qualified test equipment.

Test Equipment
• Approved materials used in protocol
Calibration
execution .
Verification
• List calibration date and next due date

Standard Pre Approved, Implemented :

Operating • Operating, setup and/or cleaning procedures
Procedures • Maintenance Procedures.
 SECTION REQUIREMENT/CONTENT

• Identify and challenge critical alarms

associated equipment/system.
Alarm/Control
• Systems integrated with other systems can be
Challenges
part of other protocols and challenged
separately.
• Define and Verify the key and critical process
parameters .
Operating
• Validate the operating ranges and acceptance
Parameters
criteria for each parameter.

Provide rationale for:

Rationale and  Qualification approach taken

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

 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
 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.
 PERFORMANCE QUALIFICATION
PQ

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.
 PPQ?
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.
 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.

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.
 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

PROTOCOL EXAMPLES

WHO

ISPE
THANKS
Any Questions?