Validation Strategies For Equipment From Multiple Vendors

Welcome to our E-Seminar:
Validation Strategies for Equipment

from Multiple Vendors
Dial +44 20 7162 0187 Chairperson John Vis for e-Seminar Audio
Page 1
Content
FDA guidelines and inspectional observations
Validation & Qualification Approaches
Instrument Qualification in Multi-Vendor Environments
Page 2
Warning Letters - Laboratory Related

There were no written procedures for the HPLC system on validation, on HW &
SW change control, revalidation, user operations, data and system security,
disaster recovery, back-up and audit trail archive.
The functional, operational and security features of the data acquisition and
storage HPLC software have not been challenged or validated for accuracy or
for reliability.
The HPLC system was not validated to show that info was accurately
exchanged between the hardware (HW) and the software (SW).
Ref: www.fdawarningletter.com
Page 3
Validation
Definition
Continuous process
.. establishing documented evidence which

.. establishing documented evidence which
provides a high degree of assurance that a

provides a high degree of assurance that a
specific process will consistently produce a
specific process will consistently produce a
product meeting its predetermined
product meeting its predetermined
specification.
specification.
Source:
FDA guidelines on General Principles of
Source: FDA
guidelines
Validation,
March
1986 on General Principles of
Validation, March 1986
Specify/
develop
Change
control
Check for
specification and
document results
Validation means nothing else than well-organized, well- documented

Validation means nothing else than well-organized, well- documented
common sense (Ken Chapman, 1985)
common sense (Ken Chapman, 1985)
Page 4
Validation Master Plan

Scope, e.g., for all regulated environments
Glossary, e.g., validation
URS
PQ
FS
Responsibilities, e.g., validation team

Steps for validation, e.g., V or 4Q model
OQ
IQ
DS
Build
Procedures for tests and acceptance criteria

Release procedure, e.g., who has to approve
Content of validation report
Documentation and archiving
DQ
IQ
OQ
Discontinuance
PQ
Example masterplan for equipment - computers - networks
www.labcompliance.com/books/masterplan.htm
Page 5
Common Qualification Terms

Guideline: Although vendors may provide information and documentation to assist
their users in meeting their responsibilities under the IQ and OQ,
validation remains the responsibility of the end user.
I.
Design Qualification (DQ)

Defines the functional and operational specs of the instrument and details the
conscious decision in the selection of the supplier
II.
Installation Qualification (IQ)

"Establishes that the system is received as designed and specified,
that it is properly installed in the selected environment, and that this
environment is suitable for the operation of the system."
III. Operational Qualification (OQ/PV)

"The process of demonstrating that an instrument will function
according to its operational specifications in the selected environment."
IV. Performance Qualification (PQ)

"The process of demonstrating that an instrument consistently performs according to a
specification appropriate for its routine use.
Page 6
The Homogeneous Laboratory

Environment
9Limited types of equipment
9Supplied by a single vendor
9One harmonized plan

9One qualification procedure
9One service provider
Page 7
The Typical Laboratory Environment
Chillers/Heaters
Mixed Vendor LC/MS
Chromatography equipment from multiple vendors
Refrigerators/Freezers
Dissolution
pH meters
Page 8
Instrument Qualification in the Typical Lab

Environment
Multiple qualification procedures for similar types of equipment
Multiple testing conditions
Multiple reports types
Multiple service providers
Increased time and effort
Increased difficulty justifying procedures for regulatory audit
Increased cost
Page 9
Agilents Harmonized Compliance Service

A single, consistent approach to instrument hardware qualification
that is vendor-neutral in scope.
Agilent offers a full complement of preventative maintenance (PM),
installation qualification (IQ), and operational qualification (OQ)
services
Broad availability backed by Agilent Technologies
Reduction of costs associated with audit preparation or challenged
audits
Focus on your mission, not on compliance
Agilent Technologies and LabMetrix Technologies have teamed to offer
the most comprehensive instrument compliance services available.
Page 10
Multi-Vendor Qualification Services

Multi-Vendor, Multi-instrument
Equipment List
Page 11
A Consistent Metrology-Based Approach

The key to harmonized qualification is use of the GLP-100
GLP-100 System is an integrated NIST- and COFRAC-traceable validation tool for any
brand LC, LC/MS/MS, GC, GC/MS, CE, Oven
A tool that measures the basic physical parameters of instruments
Allows for standardization AND flexibility - definable test conditions
Designed to qualify a broad range of instruments, independent of instrument manufacturer
Allows a straightforward comparison of the performance of instruments from multiple

manufacturers
Helps make instrument validation a traceable, repeatable and efficient process while
maintaining compliance with FDA and ISO regulations
Page 12
Rigorous Quality Processes

Software validated according to GAMP 4 guidelines
establishes a common language and terminology
improves compliance with regulatory expectations by defining a common and
comprehensive life cycle model
clarifies the division of responsibility between user and supplier
provides better visibility to agreed quality standards
aids the production of systems that are fit for purpose and that meet user and business
requirements
Audit-ready documentation
Formal change-control process for documents, software and delivery-equipment
Qualified (IQ and OQ) control & acquisition software (GLP 100)
Systems calibrated and traceable to international standards
Formal certification process for delivery engineers
Page 13
Break Number 1
Please type your

question into the
Chat Box at any time
during the presentation.
Page 14
Example
A Validation of a HPLC System
Pump
Automatic Injection
Diode Array Detector
Column Heater
Digital Data Acquisition
Page 15
Pump System
User selects 3 flow rates
Test parameters
Accuracy (Module pass/fail recommended)
Stability (Module pass/fail recommended)
Linearity over selected range
Flow vs. Pressure stability
Gradient Linearity (Module pass/fail recommended)
Page 16
Automatic Injector and Column

Compartment
User selects 5 injection volumes
Test parameters
Reproducibility (Module pass/fail recommended)
Relative accuracy
Linearity
User selects 3 temperature settings
Test parameters:
Temperature accuracy (Module pass/fail recommended)
Temperature stability (Module pass/fail recommended)
Temperature linearity
Page 17
DAD/PDA Detector
User selects 10 wavelength settings
Test parameters:
Wavelength accuracy (Module pass/fail recommended)
Wavelength linearity
Response linearity (Module pass/fail recommended)
Noise (Module pass/fail recommended)
Drift
40
Zero offset
R esponse
Target Wavelength
Impurity Spectra
Drug Spectra
205
215
225
235
245
255
265
275
Wavelength (nm)
Page 18
Multi-Vendor OQ Report
Qualification Date
Qualification Date
7-Aug-02
QUALIFICATION REPORT
P01
HPLC
HPLC PUMP
AGILENT G1311A
N 02QQ0708-R1P1
Test Location:
Department:
Location:
Operator:
Title:
DE822036
FLOW RATE STABILITY - FLOW 1
Tested Module
System ID: HPLC US01
Module ID: P01
Type: HPLC PUMP
Englewood Colorado 80112
Support Lab
Manufacturer/Model Number: AGILENT G1311A
Training Center
Serial Number: DE822036
Room 214-A
Entered Service: 30-Sep-99
Jane Jones
Last Qualification: 28-Sep-01
Compliance Engineer
Next Qualification: 7-Aug-03
XYZ PharmaCo
9780 South Meridian Blvd
Operating Conditions
Pump:
Duration (min):
Solvent:
Maximum Pressure (Bar):
Flow (ml/min):
Standard Solution Reference:
Batch Number:
Date Solution Expires:
Table of measured
results
Time (min)
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
Mean
RSD (% )
Max. Difference
Details of GLP100
GLP100 Serial Number : RY413
Date Calibration Expires : 31-Jan-03
A
60
Deionized Water
156.80
0.5 - 1 - 2
Potassium Dichromate 981
0270KDC-EPC50X-1
9-Sep-02
ab T emp and Humidity (C_%RH): 22.30 _ 65.80
Protocol N:
PR.09.01.10
Equipment Used (ID, Type, Model, S erial N, Report N)

GLP10 0 Detecto r
Mean (20 Values)

(ml/min)
Mean RSD (Flow) (% )
STATISTICAL SUMMARY
PARAMETERS
Pump
Flow
Measured Specification
Min
Max
COMPLIES
YES
0.16%
0.08%
0.24%
0.498
1.006
2.020
0.24%
1.27%
0.22%
0.17%
0.23%
1.00%
1.00%
1.00%
5.00%
5.00%
5.00%
2.00%
8.00%
2.00%
2.00%
2.00%
0.475
0.950
1.900
0.525
1.050
2.100
0.5020
NO
X
X
X
X
X
X
X
X
X
X
X
Pressure (Bar)
152.3
151.6
151.1
151.0
150.7
150.3
149.9
149.7
149.5
149.3
150.5
0.65%
3.0
Bar
0.4998
0.10%
160.0
GRAPHS OF FLOW RATE STABILITY - FLOW 1
0.5010
0.5020
160.0 140.0
0.5010
0.5000
140.0
0.5000
0.4990
0.4990
100.0
100.0
0.4980
0.4980
80.0
0.4970
0.4970
60.0
0.4960
0.4960
SIGNATURES
Approval Date:7 -Aug-02
NO
XYZ PharmaCo
SIGNATURES
20.0
John Smith - Quality Manager
Report Date:
7-Aug-02
0.0
0.5
YES
For Agilent Technologies
1.0
1.5
2.0
0.4930
0.5
1.0
1.5
2.0
Series 1
Series 1
Jane Jones
This document is the property of Agilent Technologies under license from LabM etrix Technologies. No copying, all or partial, is
permitted without prior authorization.
60.0
40.0
0.4950
0.4940
NO
MODULE COMPLIES
YES
80.0
40.0
0.4950
0.4930
0.4940
MODULE COMPLIES
120.0
120.0
Dbit
(ml/min)
Flow (ml/min)
0.500
1.000
2.000
0.500
Accuracy
1.000
(ml/min)
2.000
Flow/Pressure Stability (% )
Flow Linearity (% )
A-B
Gradient Linearity (% )
C-B
D-B
Flow Rate Stability
(% )
Flow 1 - Stability
0.500 ml/min
Pressure (Bar) Series 2
55.1
0.5014
55.1
0.5012
55.1
0.5014
55.1
0.5009
55.1
0.5011
55.1
0.5013
55.1
0.5008
55.1
0.5014
55.1
0.5011
55.1
0.5009
55.1
0.5012
0.00%
0.05%
0.0
0.0006
Bar
ml/min
Series 1
0.4984
0.4987
0.4988
0.4987
0.4991
0.4963
0.4987
0.4987
0.4988
0.4987
0.4985
0.16%
0.0028
ml/min
02Q Q 0708-R1P1
Pression (Bar)
Company
Pressure (Bar)
7-Aug-02
For Agilent Technologies:
Report Date:
2.5
3.0
3.5
4.0
Te mps (min)
Time (min)
2.5
3.0
3.5
4.0
Series 2
Pressure (Bar)
Pressure (Bar)
Series 2
Pressure (Bar)
4.5
20.0
5.0
0.0
4.5
5.0
Pressure (Bar)
7-Aug-02
This document is the property of Agilent Technologies under license from LabM etrix Technologies. No copying, all or partial,
is permitted without prior authorization.
Page 19
Qualification Process & Documentation

Flow (1)
Detailed equipment list created
Qualification Master Plan (QMP) developed
QMP details testing specifications for all equipment to be qualified
Special operating conditions (SOC) developed & documented, as needed
Internal QMP quality review and customer review
eQMP downloaded to GLP 100 software (acquisition & control) for GLP 100
system control (self-contained, calibrated, metrology device)
Delivery schedule defined and implemented
Page 20
Qualification Process & Documentation

Flow (2)
OQ pass
review with customer
interim qualification report & calibration certificate left for each module
final qualification report and calibration packet within 10 days
calibration certificates (for instruments)
certificates of analysis (chemical standards)
engineers training record
SOC report (if required)
OQ failure
review with customer
qualification form indicates failure detail
after repair, RQ implemented from GLP 100 software
RQ report added to initial OQ report
(note: failure is electronically documented & cannot be deleted)
eQMP and SOCs are retained for the lifetime of qualification service
specific instrument details and qualification history electronically archived
for 5 years
Page 21
Qualification Protocols
Protocol Contents:
Qualification Protocol
Scope
Definitions
No. : PR.09.01.44_A
Liquid Chromatograph
MASS SPECTROMETER
Version: 1.0
Page: 1/5
Applicable documents
Range of application
Operational Qualification
Formulae
Protocols are general for each type of equipment

QMP contains specific test conditions and pass-fail criteria
All protocols are strictly followed during qualification. Deviations, for
technical reasons, must be approved and will be documented
Protocols are available for review under signed non-disclosure
agreement
Page 22
Select Multi-Vendor Compliance

Customers
Page 23
Summary Recommendations
Form a validation team (include IT!)
Develop validation master plan
Define user requirements and functional specifications
Qualify the vendor
Perform and document qualifications
Evaluate the need for retrospective evaluation and develop a
plan
Document
Page 24
Resources
Pub No. 5988-9576EN
Page 25
Resources
GLP/GMP Primer from Agilent Technologies
Basics of GLP/cGMP
Impact on Laboratories
Equipment validation/qualification
Computer validation
FDA 21 CFR Part 11
Method validation (ICH, USP)
Vendor contributions
Glossary
Agilent Publication 5968-6793E
Page 26
Resources
www.labcompliance.com
L.Huber
Validation of
Computerized Analytical
and Networked Systems
Global on-line resource for

validation&compliance issues in
laboratories
Regulatory news
Discussion forum
Monthly newsletter
Interpharm Press
Usersclub with free downloads
www.labcompliance.com
Links to literature, documents and

other websites
Several pages dedicated to 21CFR11
Page 27
Agilents Compliance Solutions

Agilent was independently rated #1 for Compliance expertise
Vendor-independent, global solution for all laboratory analytical
instruments
A responsive, experienced team focused on helping you
succeed
Reduced validation costs
Can we partner with you?
Page 28

Validation Strategies For Equipment From Multiple Vendors

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Welcome to our E-Seminar:

Validation Strategies for Equipment

Warning Letters - Laboratory Related

.. establishing documented evidence which

provides a high degree of assurance that a

Validation means nothing else than well-organized, well- documented

Validation Master Plan

Responsibilities, e.g., validation team

Procedures for tests and acceptance criteria

Common Qualification Terms

Design Qualification (DQ)

Installation Qualification (IQ)

III. Operational Qualification (OQ/PV)

IV. Performance Qualification (PQ)

The Homogeneous Laboratory

9One harmonized plan

The Typical Laboratory Environment

Instrument Qualification in the Typical Lab

Multiple qualification procedures for similar types of equipment

Multiple testing conditions

Multiple reports types

Multiple service providers

Increased time and effort

Increased difficulty justifying procedures for regulatory audit

Agilents Harmonized Compliance Service

Multi-Vendor Qualification Services

A Consistent Metrology-Based Approach

A tool that measures the basic physical parameters of instruments

Allows for standardization AND flexibility - definable test conditions

Designed to qualify a broad range of instruments, independent of instrument manufacturer

Allows a straightforward comparison of the performance of instruments from multiple

Rigorous Quality Processes

Please type your

Automatic Injector and Column

FLOW RATE STABILITY - FLOW 1

Equipment Used (ID, Type, Model, S erial N, Report N)

Mean (20 Values)

GRAPHS OF FLOW RATE STABILITY - FLOW 1

John Smith - Quality Manager

For Agilent Technologies

For Agilent Technologies:

Qualification Process & Documentation

Qualification Process & Documentation

Protocols are general for each type of equipment

Select Multi-Vendor Compliance

Pub No. 5988-9576EN

Global on-line resource for

Usersclub with free downloads

Links to literature, documents and

Agilents Compliance Solutions

Can we partner with you?

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