Lanese_Jerry_Session 7 Method val.pdf

IVT
Laboratory Compliance Week
Laboratory Instrument
Qualification
Demonstrate Suitability for use

Jerry Lanese
The Lanese Group, Inc.
1
2015 The Lanese Group, Inc.
Why are you here?
2
Outline
Requirement for instrument qualification
The industry solution
Maintaining qualification
Interactive exercise
3
It is the goal of every analyst and every
quality control laboratory to report data
that accurately reflect the measured
parameters of the material under test.
4
It is:
Good business
Good science
That we provide assurance that

each instrument performs as
intended with appropriate
uncertainty.
5
It is:
Also required by the regulations.
6
Where?
7
Where?
Automatic, mechanical, or electronic equipment or
other types of equipment, including computers, or
related systems that will perform a function
satisfactorily, may be used in the manufacture,
processing, packing, and holding of a drug product. If
such equipment is so used, it shall be routinely
calibrated, inspected, or checked according to a written
program designed to assure proper performance.
Written records of those calibration checks and
inspections shall be maintained.
21CFR211.68
8
EU
It is a GMP requirement that manufacturers

control the critical aspects of their particular
operations through qualification and validation
over the life cycle of the product and process.
Annex 15
9
Each laboratory should implement
procedures that provide the highest
level of assurance of the quality of
the data reported.
10
Components of Data Quality
Quality
Control
Check Samples
System
Suitability Tests
Analytical Method Validation
Analytical Instrument Qualification
USP <1058>
11
Components of Analytical Instrument Qualification
4 Qs
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Define your terms

12
The boundaries of qualifications activities are
fuzzy.
DQ IQ
OQ
PQ
Define your terms

13
Components of Instrument Qualification
Instrument Lifecycle
ICH Q10 Pharmaceutical Quality System
Pharmaceutical Technology Commercial Product
Development Transfer Manufacturing Discontinuance
Investigational GMP
Products
Management Responsibilities
Process Performance and Product Quality Monitoring System

PQS Corrective Action/Preventive Action (CAPA) System
Change Management System
Elements
Management Review
Knowledge Management
Enablers
Quality Risk Management
2015 The Lanese Group, Inc. 15 ICH Q10 4 June 2008
User Requirements
Instrument Lifecycle
Development Technology Commercial Instrument
Transfer Testing Discontinuance
Measuring Process Lifecycle
Stage 2 Stage 3
Stage 1 Process Continued Process
Process Design Qualification Verification
16

Laboratory Instrument and Equipment Lifecycle
Identify and document

intended use
17
Intended use includes:
What material will be tested?
What other analytes will be present?
What stage of the product lifecycle.
18
Investigational GMP
Products

Elements
Management Review
Enablers
Intended use includes:
What material will be tested?
What other analytes will be present?
What stage of the product lifecycle.
What stage of the production process?
What attribute will be determined?
What are the attribute specifications?
What laboratory will be performing the test?
What analysts will be performing the test?
Education
Training
Experience
20
Laboratory Instrument and Equipment Lifecycle
Identify intended use DQ

Qualify vendor
Review Instrument capabilities
Specifications
Receive instrument
Install IQ OQ PQ
Decommission Use
21
The 4Q Model
DQ IQ OQ PQ
Continued
use
Routine,
Change
periodic
Control
check
Move
Instrument
and original
application
Change
Intended
use
22
What should be included in the qualification?
Intended use
Risk analysis
IQ OQ PQ
23
Change Control
The establishment of any specifications,
standards, sampling, test procedures, or other
laboratory control mechanisms required by this
subpart, including any change in such
specifications, standards, sampling plans, test
procedures, or other laboratory control
mechanisms, shall be drafted by the appropriate
organizational unit and reviewed and approved
by the quality control unit.
21CFR211.160(a)
24
Investigational GMP
Products

Elements
Management Review
Enablers
Master Plan
The organization should have a Master Plan

for all validation activities. (VMP)
Site or laboratory
Includes instrument/equipment qualifications.
Provides general guidance on each step of the
validation and qualification process.
Supported by specific activity SOPs
May include IQ, OQ and OQ templates.
26
Validation Master Plan
Qualification of Laboratory
Instruments and Equipment
Determining Receiving new Preparing

intended use laboratory Installation
instruments Qualification
Protocols
Operational Operational
Qualification Qualification Handling Quality Review of
of Balances of HPLCs Deviations to Validation Protocols
Validation and Reports
Trending of Protocols
Performance Archival of
Qualification Qualification
Data Reports 27
Items that might be included in
instrument/equipment qualification master plan
Scope of the plan (total site, laboratory)
Responsibilities
Reference to related plans and procedures
Equipment that is to be qualified
Overview to the approach to qualification
Requirement and guidance for risk assessment
The steps of instrument/equipment qualification
Evaluation (qualification) of vendors
Change control
Decommissioning of instruments
Templates
28
DQ
The documented collection of activities that
define the functional and operational
specifications of the instrument and criteria for
the selection of the vendors, based on the
intended purpose of the instrument.
USP <1058>
29
DQ should include:
Record all observations. Use templates where possible
Design and produce instrument that meets

defined requirements.
Determine intended use.
Identify vendors who operate under a robust
quality system and produces an instrument that
meets intended use
Select vendor
Qualify vendor
Order
30
Performed by
Developer (instrument manufacturer)
Robust design
Based on functional requirements
Product specifications
Discussions
User (Organization installing the unit)
Understand the test process and why it was selected.
Define intended use of instrument/equipment.
Determine functional requirements and
specifications.
Select and evaluate vendor.
31
VMP may include template for any or all of

the information that should be collected.
32
Understand and document the
intended use of the instrument.
Type of test
Location
Monitored process
Specifications
Technical competence of users
33
IQ
The documented collection of activities
necessary to establish that an instrument is
delivered as designed and specified, and is
properly installed in the selected environment,
and that this environment is suitable for the
instrument.
USP <1058>
34
IQ should include:
Record all observations. Use templates where possible.
Assure that the laboratory utilities and facility

meet vendor requirements.
If critical, assure that environmental
conditions are controlled and recorded.
Assure that all items listed on purchase order
have been received.
Determine that there has been no damage to
the instrument/equipment during shipment.
35
IQ should include:
Verify that the materials and construction are

consistent with vendor specifications and user
requirements.
Assure that all documents (operating manuals,
maintenance and testing procedures, safety
procedures, validation certificates) are present
and complete.
Install hardware: fittings, tubing for fluid or gas
flow, HPLC or GC columns, power cables, date or
network cables, other cables.
36
IQ should include:
Switch instrument and modules on. Ensure

that modules power up and software boots
up.
Perform any self test routines.
List equipment manuals and pertinent SOPs
Record system and component model
numbers and serial numbers.
Record firmware and software revisions.
37
IQ should include:
Enter instrument model number, serial

number and other required instrument data
into the instrument asset management
database.
Prepare required installation report(s).
Prepare, review and sign IQ documentation.
38
Will IQ be repeated?
DQ IQ OQ PQ
Continued
use
Routine,
Change
periodic
Control
check
Move
Instrument
and original
application
Change
Intended
use
39
OQ
necessary to demonstrate that an instrument, or
equipment, will function according to its
operational specifications in the selected
environment.
USP <1058>
40
Typical issues:
What should be tested?

What process should be used for the testing
What are the acceptance criteria?
Who should perform the testing?
41
USP guidance
Users, or their qualified designees, should

perform appropriate tests to verify that the
instrument meets manufacturer or user
specifications in the users environment.
USP <1058>
42
What should be tested?
Parameters that will demonstrate that the

instrument is consistently operating in a
state of control in conformance with
applicable specifications.
43
What process should be used for the testing?
All tests should be defined in the protocol.

Vendor protocol and testing may be used.
As much as possible rely on SOPs.
Where internal SOPs do not exist, tests
should be described in detail in the
protocol.
44
Any vendor protocol or test should
have appropriate internal technical
review and quality approval.
45
What are the acceptance criteria?
Acceptance criteria should be based on the

intended use of the equipment or
instrument. They should be based on good
science, risk and process uncertainties.
46
Who should perform the testing?
Testing may be performed by vendors,

contractors or internal resources.
All individuals involved in the qualification
process should be qualified with the
appropriate education, training and/or
experience.
47
Should be repeated routinely

according to a program.
48
The 4Q Model
DQ IQ OQ PQ
Continued
use
Routine,
Change
periodic
Control
check
Move
Instrument
and original
application
Change
Intended
use
49
PQ
necessary to demonstrate that an instrument
consistently performs according to the
specifications defined by the user, and is
appropriate for the intended use.
USP <1058>
50
Continued Process Verification
is a part of
Quality
Control
Check Samples
System
Suitability Tests
Analytical Method Validation
Analytical Instrument Qualification
51
Consistent
Trend
System capability
Statistical evaluation
52
Investigational GMP
Products

Elements
Management Review
Enablers
Conditions should replicate routine testing

process.
Performed whenever instrument is used.

Frequency dependent on:
Test criticality. RISK
Instrument and system robustness.
Component dependability.
USP <1058>
54
4 Qs
The organization should develop a laboratory

equipment and instrument qualification
program that covers the 4Qs.
55
Complete, in depth qualification of
all laboratory equipment and
instruments requires extensive
resources
Is there an efficient way to

accomplish instrument qualification?
56
Industry recognition of the issue
Formation of an industry committee
Evaluation of the risk associated with

equipment and instruments
Identification of risk groups
USP <1058>
Instrument/equipment Groups 57
The Laboratory Instrument/Equipment World
A B
C
58
Group A
Standard equipment with no measurement
capability, or requirement for calibration. The
manufacturers specification of the functionality
is accepted as user requirement.
Nitrogen evaporators
Magnetic stirrers
Vortex mixers
centrifuges
59
Group A
Conformance of equipment with user

requirements may be verified and documented
through visual observation of its operation.
Basic IQ
Limited OQ
60
Group A
Magnetic stirrer
DQ
Verify that specifications for the identified stirrer demonstrate
that it will stir the target liquid at the desired rpms.
IQ
Verify that ordered item and accessories were delivered.
OQ
Verify that the stirrer will stir the target liquid.
61
Group B
Standard equipment and instruments that
provide measured values. Also, equipment
controlling physical parameters that need
calibration where the user requirements are
typically the same as the manufacturers
specification of functionality and operational
limits
62
Group B
Balances Muffle furnaces
Melting point apparatus Ovens
Refrigerators
Microscopes (light)
Freezers
pH meters
Water baths
Variable pipets Pumps
Refractometers dilutors
Thermometers
Titrators
Viscometers
63
Group B
Conformance of the instrument or equipment to

user requirements is determined in accordance
with SOPs for the item. It is documented during
IQ or OQ.
Basic IQ
Detailed OQ based on site SOPs
Routine PQ based on site SOPs
64
Group B
Analytical balance
Careful with terminology
65
Group B
Analytical balance
Careful with terminology
66
Group B
Analytical balance
DQ
Identify vendors that market analytical balances
that operate in a range that meets the intended
use.
Identify which models will operate in the desired
range.
Determine if vendor provides desired support.
Determine if marketed balance performs, in
accordance with user requirements and
specifications.
67
Group B
Analytical balance
IQ
Verify that the correct item and accessories were
delivered without damage.
Verify that the area environment is consistent with
manufacturers or users requirements and USP <1251>.
HVAC
Free of vibration
Free of air currents
Low humidity
68
Group B
Analytical balance
IQ (continued)
Verify balance is in the appropriate asset control system.
Verify that appropriate SOPs are in place.
Operating
Calibration
Other, as appropriate
Performance qualification
Weight checks
69
Group B
Analytical balance
IQ (Continued)
Verify that operators have documented and appropriate
training.
Education, training, experience
Verify that balance is installed correctly.
Verify that balance will turn on and execute defined start-
up routine.
Verify that appropriate standards and accessories are in
place.
70
Group B
Analytical balance
OQ
Verify that balance performs in accordance with
USP <1251>
Mechanical mobility
Control of stable indication
Manually triggered or automatic adjustments
Operation of ancillary equipment
Tare function
Calibration
Sensitivity
Linearity
Eccentricity
Repeatability
Minimum weight
71
Group B
Analytical balance
PQ
Perform check weigh procedures
Perform other items listed in USP <1251>, as
appropriate.
72
Group B
Oven, Refrigerator, Freezer
IQ
Verify that the correct item and accessories were
delivered without damage.
Verify that the area environment is consistent with
manufacturers specifications.
Verify item is in the appropriate asset control system.
Verify that appropriate SOPs are in place.
Operating
Calibration
Performance qualification
73
Group B
IQ (Continued)
Verify that operators have documented and appropriate
training.
Education, training, experience
Verify that item is installed correctly.
Verify that item will turn on.
74
Group B
OQ
Turn on equipment
Demonstrate that it will come to and hold a defined
temperature. (Dependent upon intended use.)
Where required (dependent upon intended use) map the
temperatures throughout the chamber.
75
Group B
PQ
Monitor controlled parameter.
Trend the parameter.
76
Group C
Instruments and computerized analytical
systems. User requirements for functionality,
operational limits and functional limits are
specific to the intended use (the analytical
application).
77
Group C
Atomic absorption spectrometer
Differential scanning calorimeter
Thermal gravimetric analyzer
Dissolution system
Electron microscope
HPLC
GC
Mass spectrometer
Microplate reader
X-ray fluorescence
X-ray diffraction
Densitometer
Elemental analyzer
IR and NIR spectrometer
Vis/UV Spectrophotometer
78
Group C
Conformance to user requirements is
demonstrated by specific function tests and
performance tests.
Installation (and qualification) of the

instrument is complicated and may require
assistance.
A full qualification process is required.
79
Group C
Extensive IQ
Extensive OQ in part based on site SOPs
Routine or continuing PQ, in part based on

specific test system suitability, control sample
testing or specific site SOPs.
80
In order to have an effective instrument qualification
program, other Quality System systems must be in
place and functional. These include:
Training
Documentation (policies and procedures)
Records
Maintenance
Calibration
Deviation
Investigation
CAPA
Control samples
Total validation program
81
Implementing the concepts
Qualification of laboratory equipment and
instruments is a requirement.
There is no requirement that an organization use the

concepts of USP <1058>
If the organization has an adequate, alternate plan

use it.
Design and implement a system for the
qualification of laboratory equipment and
instruments!
82
Implementing AIQ
Validation system
VMP
Instrument qualification SOP
Divide all instruments into the three categories.
Establish general procedures for the qualification of
instruments in each category.
Establish procedures for specific instrument
calibration, performance testing and related
activities.
Create a priority list based on risk.
Qualify each instrument according to a plan.
83
Interactive Exercise
84
Good Luck!
Questions
85
For further reference start with:
A Primer:
Analytical Instrument Qualification and System
Verification
By: Ludwig Huber

Agilent Technologies
86
IVT
Laboratory Compliance Week
Laboratory Instrument
Qualification
Demonstrate Suitability for use

Jerry Lanese
87
Contact Information
Jerry Lanese
Ph.D.

913 915 3276
jerry@lanesegroup.com
www.lanesegroup.com
88

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Related titles

IVT

Laboratory Compliance Week

Demonstrate Suitability for use

That we provide assurance that

Also required by the regulations.

It is a GMP requirement that manufacturers

Analytical Method Validation

Analytical Instrument Qualification

Define your terms

Define your terms

Process Performance and Product Quality Monitoring System

Measuring Process Lifecycle

2015 The Lanese Group, Inc.

Identify and document

Process Performance and Product Quality Monitoring System

Identify intended use DQ

Process Performance and Product Quality Monitoring System

The organization should have a Master Plan

Determining Receiving new Preparing

Design and produce instrument that meets

VMP may include template for any or all of

Assure that the laboratory utilities and facility

Verify that the materials and construction are

Switch instrument and modules on. Ensure

Enter instrument model number, serial

What should be tested?

Users, or their qualified designees, should

What should be tested?

Parameters that will demonstrate that the

All tests should be defined in the protocol.

What are the acceptance criteria?

Acceptance criteria should be based on the

Who should perform the testing?

Testing may be performed by vendors,

Should be repeated routinely

Analytical Method Validation

Analytical Instrument Qualification

Process Performance and Product Quality Monitoring System

Conditions should replicate routine testing

Performed whenever instrument is used.

The organization should develop a laboratory

Is there an efficient way to

Formation of an industry committee

Evaluation of the risk associated with

Identification of risk groups

Conformance of equipment with user

Conformance of the instrument or equipment to

Careful with terminology

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Installation (and qualification) of the

A full qualification process is required.

Extensive OQ in part based on site SOPs

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