qualification protocols

qualification protocols

Procedure for Validation of a System/Equipment: QP Checklist

Step 1:: Define quality attributes on “fitness for use or purpose”
basis
Step 2: Design Qualification
Step 3: Source and procure
Step 4: Factory Acceptance Tests
Step 5: Site Acceptance Tests
Step 6: Installation Qualification - As built phase
Step 7: Operational Qualification - At rest phase
Step 8: Performance Qualification - Operating phase
Step 9: Confirm appropriateness of critical process parameters
establish reproducibility and reliability of system
establish stability under seasonal or other changes
confirm appropriateness of target, alert, alarm levels and
corrective action plan
Step 10: Prospective/Concurrent/Retrospective validation
Change control
Periodic review/Revalidation
Protocol stages: Checklist
1 Protocol approval
2 Overview - Objective
Purpose
Reason for validation
Responsibility
Revalidation
3 Design Qualification – defining inputs
4 Acceptance Criteria
5 References
6 Installation Qualification
7 Operational Qualification
8 Performance Qualification
9 Approvals
Protocol Format
1 Protocol approval
Identify people who will be jointly responsible for
* System design
* System validation
* Checking and approving validation documentation

2
 qualification protocols

Functional Area Name Signature Date

2 Overview
2.1 Objective
To assure that the system will consistently produce_______
of predictable quality when operated in prescribed manner:
all physical aspects, related procedures, process monitoring
and control all function as per specifications.
2.2 Purpose
To demonstrate that the design, construction,
commissioning and operation of the system is suitable for
the intended purpose and possesses the quality attributes to
render it cGMP compliant and meets regulatory
obligations.
2.3 Reasons for validation
* To demonstrate that system design (with all
components) is compatible with system functions
* To demonstrate that system has the capacity to achieve
specified quality levels
* To verify that operation, cleaning, sanitation, and
maintenance procedures for system are acceptable
* To establish that sampling plan has the capacity to
determine whether or not the system is under control
* To establish that operating and maintenance people are
adequately trained
* To verify that a proper system of documentation and
record maintenance exists
2.4 Responsibility
* Production Manager
* QA Manager
* Validation Manager
* Engineering Manager
* Process Development Manager
2.5 Revalidation
System to be revalidated on:
* Substitution of existing system or sub-system with
new system or sub-system

3
 qualification protocols

* Major modification to existing system or sub-system

since commissioning or after last validation
* Excursions from nominal set point observed during
routine continuous monitoring
3 Reference documents
1 SOPs for assemblies and sub-assemblies
2 Calibration of motors, gauges, indicators, meters
3 Utilities required
4 Sampling plan and procedures
5 Test procedures

Design Qualification Format for a System/Equipment

1. Pre-approval/post-approval joint responsibilities of protocol
Functional Area Name Signature Date

2. Purpose
To provide an outline for the design of the equipment/system to be
procured and ensure that it meets cGMP and Regulatory expectations
3. Design input
* Overview of system, sub-assemblies, and components – how they
function and recommended materials of construction; raw material
data; finished material expectations
* Special concerns, if any, and recommended care during
manufacture and installation
4. Design basis
* Specifications in terms of bill of materials
5. Acceptance criteria
* Parametric definitions with tolerances
6. System description
* Sketch or line diagram
7. Reference documents
* SOPs for operation, regeneration, maintenance, cleaning,
sanitation, testing etc for system/sub- systems/components
8. Manufacturer’s communication
* Description of system offered

4
 qualification protocols

Installation Qualification Format for a System/Equipment

1. Pre-approval/post-approval joint responsibilities of protocol
Functional Area Name Signature Date

2. Purpose
To verify that
1 System is installed as per approved drawings
2 System meets cGMP and Regulatory expectations
3 SOPs have been identified, drafted and listed
4 Instruments have been identified for calibration of system
5 Support utilities properly connected
6 Peripherals and electricals properly connected
7 Safety features and aspects accounted
3. Recording instructions
1 Record requested information in ink.
2 Use separate data sheet for separate components/systems, even
if there are more than one of a type, so that identity of each is
preserved
3 Sign and assign date in ink
4. System description
1 Name of system/Model/Serial No/
Manufacturer’s name, address and contact nos/
Supplier’s name, address and contact nos
2 Identification number/location
3 Use of the system/equipment and its capacity
4 Components
Component DQ specs Manufacturer’s specs Actual observation

5
 qualification protocols

5 Tabulation of physical details:

S/N Description Particulars
a Overall dimensions
b Weight
c Colour code
d Surface finish
e Motor/gearbox/belts/pulleys etc
f Electrical ratings
g Details of auxiliary equipment, if any

5. SOPs
S/N Function SOP Date of Revn No Title Next revn
No issue and date due on
a Operating
b Cleaning & sanitizing
c Calibration
d Preventive maintenance
e Testing & requalification
f Comments & observations

6. Calibration review
a. Process Instruments
S/N Instrument Location Date of Calibrated Checked Next calibrn
calibrn by by due on

b. Test Instruments
S/N Instrument Location Date of Calibrated Checked Next calibrn Component
calibrn by by due on to be calibrtd

6
 qualification protocols

7. System / Equipment Installation check-list

S/N Statement Yes or No Observed by Date
a Space for installation
b Power
c Compressed air
d Steam
e Vacuum
f Water, plumbing and drainage
g Others

8. Drawings
Category: Piping and Instrumentation
General arrangement/ schematic line diagram
Utility
Isometric
Other
S/N Title of Drawing Category Location Drawing No Date

9. Physical verification and listing of materials of construction

* Parts in contact with product
S/N Description of item Material of construction

* Parts not in contact with product

S/N Description of item Material of construction

7
 qualification protocols

10. Support utilities

S/N Utility Facility Capacity Capacity Properly connected
required available and identified
Yes No
a Power
b Comp air
c Water*
d Steam
e Vacuum
f Other
*state quality
11. Manufacturer’s submissions
1 Commissioning reports
2 Test reports
3 Calibration certificates
4 Others
12. Deficiency and Corrective Action Report
1 Description of deficiency and observations
2 Assignment of responsibility for corrective action
3 Corrective action taken, comments and observations and date
4 Work carried out by
5 Approved by
13. Final report
1 Summary
2 Analysis and evaluation of data
3 Certification
Appendix A: Definitions and abbreviations
Appendix B: Reference documents
A Manufacturer’s brochures/catalogues/manuals
B Purchase order
C List of essential spares, accessories and consumables and their
specification data sheets
Operational Qualification Format for a System/Equipment
1. Pre-approval/post-approval joint responsibilities of protocol
Functional Area Name Signature Date

8
 qualification protocols

2. Purpose
1 To demonstrate that the equipment/system performs
reproducibly and consistently
2 To document performance of the equipment/system for future
reference
3 To assure that the equipment /system performance is adequate
to support the process for which the system is intended
4 To develop SOPs for start-up, operation, shut-down and
sanitisation of the equipment/system
5 To document test procedures and criteria for acceptance
6 To define parameters that should be reproducible
7 To verify performance across full range of operation from
minimal to maximal loads, with special evaluation at upper
and lower limits
3. SOP verification
1 Is current version in use?
2 Do operating personnel understand and follow SOP
methodology and requirements?
3 Does SOP provide adequate direction and control to ensure
uniform equipment/system performance?
(Comments if answer to above is negative)
Final Remarks: SOP verification result: Pass/Fail?
4. Control panel functionality
Purpose
To demonstrate that the control panel provides proper
functionality as per description
Testing
1 Verify that all controls on the panel are properly labeled and
identified
2 Verify functionality of each component on the panel against its
stated function
3 Observe and record responses with control panel in use
Functionality test results:
Identification:Eqpmnt No/Make/Serial No/ Location of eqpmnt
Control panel serial no/ location of control panel
S/N Component of Described Description matches function
control panel function Yes No

Comments:
Reviewed and inspected by: Name/signature/date

9
 qualification protocols

5. Safety features review and check list

Indicate which of the safety features listed below are applicable,
and record the specific measures to be taken for them and verify
their completion. (All this should have featured in your URS/DQ.
At this stage you are merely reconfirming that your concerns have
been satisfactorily addressed in execution.)
A Extreme temperatures - Applicable / Not Applicable: Y / N
Hot lines / equipment insulated
Personal protection available
Heat sources identified and shielded
Signs posted to alert operators (“Surface is Hot!”)
B Pressure considerations - Applicable / Not Applicable: Y / N
All piping properly aligned
Pressure ratings of piping components is compatible with
operating conditions
Pressure release devices provided where applicable
Calculations for pressure release devices
Compressed air / gas lines can be isolated and blended to zero
energy state
ASME stamps
Vessel registered with site services for insurance registration
C Hazardous materials of fluid nature - Applicable / Not
Applicable: Y / N
Material safety data sheet (MSDS) location
If required, SOP for handling available
Spill retention provided
Toxic and flammable chemical risks controlled
Biohazards information provided
D Electrical hazards - Applicable / Not Applicable: Y / N
All wiring properly placed
All systems properly grounded
Lock-outs available on all equipment emitting ionizing
radiations
Proper shielding provided
E Moving parts - Applicable / Not Applicable: Y / N
Guards provided are in place at pinch points
Lock nut on shaft
Belt tension properly adjusted
F Noise level - Applicable / Not Applicable: Y / N
Noise level is dB on scale Ambient noise level is
Noise reduction equipment /devices in place, if required

10
 qualification protocols

G Physical environmental factors - Applicable / Not Applicable:

Y/N
Sharp edges removed or protected
Trip/fall hazards eliminated or protected against
Low clearance head space clearly indicated or eliminated
Equipment properly anchored
Eye hazards eliminated
Adequate lighting provided in the area
Warning and precautionary signs provided wherever required
H Ergonomic design - Applicable / Not Applicable: Y / N
Ergonomic risks evaluated, operators can safely and
conveniently access all areas of equipment
Adequate operator visibility
Emergency stop buttons visible, accessible, labeled, and
operational
Warning bells and lights audible, visible and functional
Belt/conveyor/table width appropriate for manual operations
Hazardous equipment not operational without safety guard
Excessive reaching, body bending, weight lifting, pushing and
pulling eliminated or minimized
Personnel protective equipment to be worn when operating is
indicated
I Dust levels - Applicable / Not Applicable: Y / N
Particulate matter concentration: Results
Respiratory equipment / devices in place, if required
6. Final Report
Analysis/evaluation of data
Certification
Reviewed & Inspected by

Appendix A: Definitions and abbreviations

Appendix B: Reference documents
A Manufacturer’s brochures/catalogues/manuals
B Purchase order
C List of essential spares, accessories and
consumables and their specification data sheets

11
 qualification protocols

Qualification Plan and Acceptance Criteria for

HVAC

MR KISHOR DATAR
Early in design, the owner and designer should discuss who will be
responsible for as-built drawings, setting up maintenance files, and
training. They should create a qualification plan for the HVAC,
including:
1 a functional description of what the systems will do;
2 maps of room pressures, airflow diagrams, and cleanliness zones
served by each air handler;
3 a list of critical components to be qualified, including the
computer controlling the HVAC;
4 a list of owner’s procedures that must be followed for qualification
of equipment and systems that affect critical variables;
5 a list of qualification procedures (IQ/OQ/PQ protocols) written
especially for the project; and
6 a list of needed commissioning equipment.
The approval procedure should also be defined in the QP. It is
important to measure and document the critical variables of a system
(such as room pressure), but it is also important to document
performance of components that affect that critical variables (e.g.,
room pressure sensors, temperature sensors, airflow volume monitor)
for GMP as well as business records. Documentation helps ensure
that replacement parts (e.g., motors) can be specified, purchased, and
installed to satisfy critical variables.
Critical components must be determined (including instruments) that
could affect critical parameters and could, through an undetected failure,
lead to product corruption. If performance data are in the qualification
records, replacement parts of different manufacture can be installed
without major change control approvals, as long as they meet
performance requirements. Owner approvals for the qualification plan
should be obtained while proceeding with detailed design.

Design Qualification
1. Prepare User Requirement, Specifications & Functional
Specifications
Include System ID, Rooms covered, Class to be maintained,
Temperature & RH conditions to be maintained within area,

12
 qualification protocols

Equipment with their loads, diversity factor, Approximate level of

filtration, Type of return from room, Lighting in lux, Approximate
manpower will be working, Differential pressure, Any ACH
requirements, safety systems to be included, concept for controlling &
monitoring system
2. Prepare Tender document with the help of Consultant, or
External expert, or if expert within
Include URS, System designing, Heat Load calculations, Codes to be
followed for design & construction, Detailed control & monitoring
system with interlocks, Detailed specifications of major items,
Guidelines to befollowed, Tentative BOQ, Drawings, documentation
requirements etc.
3. Float the tender to selected vendors
Includes issuing of tenders, explaining the technical aspects of
tender,explaining the documentation requirement, schematics, etc.
4. Receipt & Evaluation of tenders
Includes receipt of tender documents, evaluation of received tenders
for technical & commercial aspects
5. Decision Making for award of tender
Includes technical & commercial evaluation, reasoning/ rationale for
selecting vendor for awarding tender.
6. Risk Analysis
Detailed technical challenging for HVAC zoning, AHU zoning,
control & monitoring system, Equipment & lighting loads given in
URS, Differential Pressure, ACH, Air flow & control schematics,
Filtration level, Return system from room, etc. User, Consultant or
External expert, Selected vendor should jointly carry out the Risk
Analysis & minute the decisions taken, changes accepted with
reasoning / rationale for it.
7. Based on Tender document, Risk Analysis - Vendor to prepare
detailed documents & client / consultant to approve it
At minimum should include following:
AHU & HVAC zoning diagram, Detailed heat load calculations,
Detailed duct layout, Air flow with level of filtration & control system
schematics, Differential pressure diagram & pressure flow diagram,
AHU data sheet with fan selection, Dehumidifier/Recovery wheels etc.
data sheets & selection (If applicable), Design specifications for
control & monitoring system with selection of control system &
components, Typical P & ID for near coil piping of AHU /
Dehumidifier etc.. Filter selection & data sheets of filters, Typical

13
 qualification protocols

drawings - longitudinal, transverse joints, duct support etc. for

ducting, Supply & return air systems, Duct insulation etc., Data
sheets of all major items like Diff. Pressure gauges & switches, fire
dampers, volume control dampers, actuators for dampers, T & P
gauges etc.
Compilation of all the documents stated above with summary to
evaluate across the User Requirement & Risk Analysis for acceptance
of design will complete the “Design Qualification”

Installation Qualification
The installation qualification (IQ) protocol records construction
inspection to verify compliance with contract documents, including
completion of punch list work, for critical components. It may
include material test reports, receipt verification forms, shop
inspection reports, motor rotation tests, and contractor-furnished
testing and balancing. It also includes calibration records for
instrumentation used in commissioning and for installed
instrumentation (e.g., sensors, recorders, transmitters, controllers, and
actuators) traceable to National Institute of Standards and Technology
(NlST) instruments.
Control software should be bench tested, and preliminary (starting)
tuning parameters should be entered. Control loops should be dry-
loop checked to verify that installation is correct. Equipment and
instruments should be tagged and wiring labeled. Commissioning
documentation must attest to the completion of these activities and
include as-built drawings and installation-operation-maintenance
(IOM) manuals from contractors and vendors.
1. Preparing for Installation Qualification
Making copy of following documents approved during DQ phase for
cross- verification of Installation, Detailed duct layout, Detailed heat
load calculations, Air flow with level of filtration & control system
schematics, AHU data sheet with fan selection, Dehumidifier/
Recovery wheels etc. data sheets & selections (If applicable), Design
specifications for control & monitoring system with selection of
control system & components, Typical P & ID for near coil piping of
AHU / Dehumidifier etc., Filter selection & data sheets of filters, Data
sheets of all major items etc. Simultaneously prepare Installation
Check Sheet giving ref. of drawings, details etc. approved during DQ,
Include items to be checked as per GEP like Flange gaskets,
tightening of bolts etc., SOP’s - duct leak test, Hydro test, loop check,
etc.

14
 qualification protocols

2. Verification of Received Material

Verify the major items received at site against Data Sheets, Drawings
etc. that were approved during DQ phase. Make a summary report for
deviations, corrective actions & acceptance
3. Installation verification using Check Sheets & copies of
Drawings, Details approved during DQ phase
As Installation progress, verify the Installation using check sheets.
Mark the deviations if any, corrective action taken & acceptance after
corrective action.
Simultaneously verify the Installation with respect to drawings,
details approved during DQ phase using copy of these documents &
marking the respective area. Any deviation beyond corrective action
due to site constraint should be marked with reasons, carry out impact
w.r.t design & give acceptance if Impact dose not affect the design. If
impact does affect the design, carry out Risk Analysis & take the
appropriate decision. Compile Calibration /Test certificates for all
major components which will have impact on system performance.
Compilation of all the documents stated above with summary to
evaluate Installation against Design, respective codes etc. will
complete “Installation Qualification.”

Operational Qualification
The operational qualification (OQ) protocol documents startup,
including critical components. This includes individual performance
testing of control loops under full operating pressure performed in a
logical order (i.e., fan control before room pressure control). The
commissioning agent must verify that operating parameters are within
acceptance criteria.
The HVAC may be challenged under extremes of design load (where
possible) to verify operation of alarms and recorders, to determine
(and correct, if significant) weak points, and to verify control and
door interlocks. Based on observations, informal alert values of
critical parameters, which might signify abnormal operation, may be
considered.
Files should include an updated description of the HVAC system,
describing how it operates, schematics, airflow diagrams, and room
pressure maps that accompany it. Copies should be readily accessible
and properly filed. Operating personnel should be familiar with the
data in these records and be able to explain it to an agency inspector.
GMP documents should also include test reports for HEPA filters
(efficiency or pinhole-scan integrity tests) at final operating velocities.

15
 qualification protocols

If the filter installer performed the tests, the data should have been
part of the IQ package.
1. Prepare Operation Qualification Protocol
Includes checking all the operational parameters like Interlocks, Input
Utilities, Fan Performance, Actuations of control system for their
correctness.
Carry out these checks using protocol & prepare report with any
deviations, corrective actions taken & acceptance.
Completion of Report with supporting documents like printouts etc.
will complete “Operation Qualification.”

Performance Qualification
Performance qualification (PQ) is proof that the entire HVAC
performs as intended under actual production conditions. PQ is the
beginning of the ongoing verification that the system meets
acceptance criteria of the product (often called validation). This
includes documentation of
· Maintenance record keeping and final operating and maintenance
procedures in place, with recommended frequency of maintenance,
and (at the owner’s option) a procedure for periodic challenge of
the controls and alarms
· Logs of critical parameters that prove the system maintains
acceptance criteria over a prescribed time
· Training records of operators and maintenance personnel
· Final loop tuning parameters
After accepting PQ, the owner’s change control procedure should
limit further modifications to critical components (as shown on IQ
and OQ forms) that affect the product.
Once the system is operational, pharmaceutical product trial lots are
run in the facility (process validation) and the owner should regularly
monitor viable (microbial) and nonviable particles in the room.
1. Preparing for Performance Qualification:
Vendor to submit following SOPs, to be approved by Client/Consultant:
1. Measuring Velocity, Volume & calculating ACH,
2. DOP test if HEPA filter is used,
3. Particle count measurement,
4. T & RH measurement & recording,
5. Recovery, Fall Out (if applicable),
6. Any additional as per guideline & applicable for specific system.
* Client to have SOPs required for Viable checking, approved & effective.

16
 qualification protocols

1. Preparing for Performance Qualification:

Simultaneously prepare protocol for carrying out Performance
Qualification for Viable & Non - Viable with following details:
1. Locations for Particle counts, Air counts & Surface counts ref. to
guidelines & expertise
2. Frequencies for checking T & RH & minimum number of readings
per day
3. Number of days T & RH readings to be taken
4. Number of consecutive days Viable validation to be continued
5. Acceptance criteria for each parameter.
2. Performance Qualification Activity
Carry out all checks as per Protocol, using approved SOPs &
Calibrated measuring instruments.
Prepare report with acceptance criteria. Any deviations Or out of limit
readings, investigate, take corrective actions & repeat the
Performance Qualification activity again.
Compilation of Protocol, reports, investigation reports, rechecking,
final report, along with copy of all SOP’s, Calibration certificate of
measuring instruments & Summary report will complete
“Performance Qualification.”

Validation Overview Report

Prepare a “Qualification / Validation Overview” report giving
references of all summary reports, all deviations, corrective actions,
impact analysis, risk analysis, acceptance of deviations with reasoning
& conclusion.
THIS COMPLETES THE QUALIFICATION / VALIDATION
ACTIVITY.

About the author

Mr Kishor Datar is Manager, Projects at Sandoz, Mumbai, and is widely

respected in the industry for his expertise in pharmaceutical utilities
design, management and maintenance. He is blessed with the rare gift
of a “common-sense” approach to pharmaceutical engineering and
validation that has earned him both admiration and acclaim.

17
 qualification protocols

typical considerations in finalising the URS and

DQ for machinery and analytical instruments

Machinery
1. Component specifications. To be stated for all types and size(s) of
components to be handled.
2. Parametric range(s)
3. Filling or packaging rate.
4. Whether regular changes to different components sizes are
required (this is important if the change-over takes a long time
for a machine).
5. The location and environment in which the machine is to be
used, e.g., sterile area, clean room, etc.
6. The filling or packaging- line layout if the equipment is to
connect to other machinery. The infeed and outfeed positions on
equipment forming a long packaging line need to be considered.
This should include a layout drawing of the line.
7. Careful consideration by production staff is required to determine
what monitoring gauges and devices are required to help ensure
that product quality is maintained. These are classed as critical
devices. When the requirements have been defined, the accuracy
limits (or acceptable limits) must be determined for each device.
9. Consideration must be given to safeguards to prevent products or
components from becoming trapped in the equipment. It is better
to design out the areas for rogue entrapment rather than have
packaging machine operators search dozens of locations for
rouges at the end of each batch produced. with inevitable missed
rogue items due to human error .
10. Easy cleaning of equipment should be possible. The ability to
easily completely dismantle filling equipment to ensure effective
cleaning and sterilizing will help reduce the risk of
bacteriological continuation and minimize the batch/product
change- over time.
11. Easy access for maintenance and calibration is required
12. Lubrication
13. If the equipment available is computer controlled, define exactly
what type of computer system is required (try to standardize)

18
 qualification protocols

and what security measures are required, for example, access

codes, back – up systems, and alarms.
14. Standardization, wherever possible, will alleviate problems with
replacement stock holding.
15. Safety
16. Fitting unnecessary gauges and devices that do not serve either
production operation or troubleshooting requirements should be
avoided
17. Specifications should slate that critical and non-critical devices
must be sited to enable easy access for maintenance and
calibration
18. Service Manuals

Reaction vessels
Before design of the equipment following requirements shall be
considered:
o Reaction Volume
o MOC of the contact parts
o Maximum and Minimum Temperature
o Stirring Speed
o Need for vacuum distillation facilities
o Need for reflux facilities
o Need for slow charging of one of the reactant
o Need for protection of the content from moisture
o Need for maintaining inert gas environment in the vessel.
o Need for handling hazardous materials in the reactor
o Need for handling hazardous gaseous eflfluents from the reaction
vessel
o Need for scrapping the reaction product after the reaction is over
o Need for phase separation after the reaction is over
o Need for precise control of temperature and pressure during the
reaction
o Need for transfer of all inputs via vacuum and transfer all the
reaction products by vacuum
o Need for safeguarding against the accidental explosion .
o Need for observation for change in colour and state
o Need for continous monitoring of pH

19
 qualification protocols

o Need for rapid stirring

o Need for disallowing settling of material at the bottom
o Need for handling low boiling point liquids
o Need for maintaining at high temperature for prolonged time
o Need for gas purging during the reaction
Based on the above requirements the equipment design shall include
following Parameters :
o Detailed Diagram drawn to scale and labelled to show following
features ;
o Height and Diameter of the vessel
o Position of Baffles
o Position and design of the stirring device
o Position of motor and gearbox
o Position of steam jacket
o Locations of all openings, valves,joints (Type and size of the
valves shall be specified)
o Location of thermowell
o Location of Pressue gauzes,temperature recorders,flow meters,
level tubes
o Steam, chilled water, brine inlet and outlet points
o Height and Diameter of Condenser,its location and piping
o Location of Electrical Points
o Design of the scrubber attached (if any)
o Details on Vacuum line
o Design of Online Cleaning Facilities provided
In addition to the above MOC of the contact and non contact parts
and all valves shall be specified. Also, limits for hydrostatic pressure
which the system can sustain without cracking shall be specified.

Analytical instruments
Steps in Design Qualification of Analytical Equipment
• Description of the analysis problem
• Selection of the analysis technique
• Description of the intended use of the equipment
• Description of the intended environment
• Preliminary selection of the functional and performance
specifications (technical, environmental, safety)

20
 qualification protocols

• Preliminary selection of the supplier

• Instrument tests (if the technique is new)
• Final selection of the equipment
• Final selection of the supplier and equipment
• Development and documentation of final functional and
operational specifications
Steps in Vendor Qualification of Analytical Equipment
1. Develop a vendor qualification checklist.
• Does the vendor have a documented and certified quality
system, e.g., ISO 9001 (please note: ISO 9002 or 9003 is
insufficient because they don’t cover development!)?
• For products that include software: does the vendor comply
with ISO 9000-3 (Guidelines for the application of ISO 9001 to
the development, supply and maintenance of software) or an
equivalent standard or guide?
• Is equipment hardware and computer software developed and
validated according to a documented procedure, e.g., according
to a product life cycle?
• Is the vendor prepared to make product development and
validation records and source code accessible to regulatory
agencies ?
• Does the vendor provide declaration of conformity to
documented specifications ?
• Does the vendor provide assistance in design qualification,
equipment installation, qualification, maintenance and timely
repair through qualified people?
• Is there a customer feedback and response system in case the
user reports a problem or enhancement request?
• Is there a change control system with suitable notification of
users after the changes?
2. Send the checklist to the vendor
If the vendor answers all the questions satisfactorily within a given
time frame, the vendor is qualified.
3. If the vendor does not answer the questions satisfactorily, another
vendor should be considered. If there is no other vendor who could
provide an instrument that meets the operational and functional
specifications, a direct audit should be considered.

21
 qualification protocols

Steps in Installation Qualification of Analytical Equipment

Before installation
• Obtain manufacturer’s recommendations for installation site
requirements.
• Check the site for the fulfillment of the manufacturer’s
recommendations (utilities such as electricity, water and gases and
environmental conditions such as humidity, temperature, vibration
level and dust).
• Allow sufficient shelf space for the equipment, SOPs, operating
manuals and software.
During installation
• Compare equipment, as received, with purchase order (including
software, accessories, spare parts)
• Check documentation for completeness (operating manuals,
maintenance instructions, standard operating procedures for
testing, safety and validation certificates)
• Check equipment for any damage
• Install hardware (computer, equipment, fittings and tubings for
fluid connections, columns in HPLC and GC, power cables, data
flow and instrument control cables)
• Switch on the instruments and ensure that all modules power up
and perform an electronic self-test
• Install software on computer following the manufacturer’s
recommendation
• Verify correct software installation, e.g., are all files loaded.
Utilities to do this should be included in the software.
• Make back-up copy of software • Configure peripherals, e.g.
printers and equipment modules
• Identify and make a list with a description of all hardware, include
drawings where appropriate.
• Make a list with a description of all software installed on the
computer
• List equipment manuals and SOPs
• Prepare an installation report
Analytical Equipment Characterization
• In-house identification number (asset number)
• Name of the item of equipment

22
 qualification protocols

• The manufacturer’s name, address and phone number for service

calls, service contract number, if there is one
• Serial number and firmware revision number of equipment
• Computer hardware with information on the processor, hard disk
space, memory and the monitor
• `Software with product and revision number
• Date received
• Date placed in service
• Current location
• Size, weight
• Condition when received, for example, new, used, reconditioned
• List with authorized users and responsible person
Steps in Performance Qualification of Analytical Equipment
1. Define the performance criteria and test procedures.
2. Select critical parameters with some allowance to drift out of
predefined specifications. For a liquid chromatography system this
can be
• precision of the amounts
• precision of retention times
• resolution between two peaks
• peak width at half height or
• peak tailing
• limit of detection and limit of quantitation
• wavelength accuracy of a UV/Visible wavelength detector.
3. Define the test intervals, e.g.,
• every day
• every time the system is used
• before, between and after a series of runs
4. Define corrective actions on what to do if the system does not meet
the criteria, in other words if the system is out of specification
Post-Qualification Documentation of Analytical Equipment
On completion of equipment qualification, documentation should be
available that consists of:
• Design qualification document
• A vendor qualification checklist

23
 qualification protocols

• Installation qualification document (includes description of

hardware and software)
• Procedures for testing
• Qualification test reports with signatures and dates
• Entries on instrument ID in the laboratory’s instrument data base
• PQ test procedures and representative results
Frequent asked questions regarding Analytical Equipment OQ*
1. What procedures and test standards should be used: should they
reflect the intended use of the equipment or should they be generic
for the instrument category?
2. What should the acceptance criteria be: should they be in line with
the manufacturer’s specifications, or should they reflect the
intended use of the equipment?
3. Should I use the same procedures and acceptance criteria for all
instruments of the same type in my laboratory and/or in our
company ?
4. For modular systems: should I test each module, or is it enough to
test the system as a whole?
5. How frequently should the OQ tests be done?
6. Can/should the test be done by the vendor or by the user?
7. Can/should I do preventive maintenance before the OQ test ?
8. Should I requalify the equipment after moving the instrument to
another lab ?
9. Should I requalify the equipment after repair or after firmware,
software and hardware upgrades ?
10. Why do I need OQ at all if I use the equipment for one specific
application only, isn’t performance qualification enough ?

How much validation is too much validation

The challenge is to find

a good compromise
between not doing
enough and doing too Optimal
much. Validation is an band
excellent example.
Incremental Incremental
When complying right benefit costs
at the beginning of the
validation process the 0% Validation efforts 100%

24
 qualification protocols

additional value to each validation step is tremendous. However, there

is no added value in trying to validate each and every step and the
incremental costs for validation goes up with each validation effort.

The question is: ‘where is the optimum’ or ‘how much validation is

enough’. The challenge is to find the optimum and this requires a
thorough risk analysis.
* (The reader is referred to Dr Ludwig Huber’s Labcompliance
website: www.labcompliance.com for more comprehensive
information on analytical instrument validation)

25