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Calibration and Qualification
Presented By:
Assistant Professor
Miss.Priyanka Kandhare
Dept:-Pharmaceutical Quality Assurance
AISSMS COLLEGE OF PHARMACY
CALIBRATION
 “comparison of measurement system or device of unknown
accuracy to another measurement system or device of known
accuracy to detect, correlate report or eliminate by adjustment
any variation from required performance limits of unverified
measurement system or device ”
 To maintain the accuracy and precision of test equipment at all
times. To ensure highest level of confidence in all measurement
that affect materials disposition decision, with unbroken chain of
traceability to national standard.
 To determine whether the equipment is still fit for its intended
purpose.
 This is important for justifying the processes of Qualification and
Validation.
2
Objectives
 It checks the accuracy of an instrument
 It determines the traceability of the measurement
 provides confidence that your products /services /
results meet their specifications .
Purpose /Need Of Calibration
 Components age and equipment undergoes changes in
temperature or humidity or sustains mechanical stress,
performance degrades. This is called drift. Then test results
become unreliable. While drift cannot be eliminated, it can be
detected and either unreliable. While drift cannot be
eliminated, it can be detected and either corrected or
compensated for through the process of calibration.
 Properly calibrated equipment provides confidence that your
products/services/results meet their specifications .
Calibration: Optimizes resources; Ensures consistency; and
Ensures measurements (and perhaps products) are compatible
with those made elsewhere.
 By making sure that your measurements are based on
international standards, you promote acceptance of your
products/services/results .
conti...
Master Instrument List -
 Description or name
 Unique identifier
 Instrument accuracy, range, etc.
 Calibration frequency
 Location
 Expiration or due date
 Applicable calibration procedure and standards.
Scope Of Calibration
6
 To make sure that the readings of equipment or instruments are
consistent with other measurements and display the correct
readings every single time.
 To determine the accuracy, precision, reliability and deviation of
the measurements produced by all the instruments.
 To establish the reliability of the instrument being used and
whether it can be trusted to deliver repeatable results each time.
 To map the ‘drift’ as documented. Instruments have a tendency to
produce inaccurate measurements over a period of time,
following repeated use.
 Ensuring that the industry standards, quality assurance
benchmarks such as cGMP and government regulations are
adhered to.
Advantages Of Calibration
 The knowledge of the nature and extent of errors of the
testing and measuring the instruments employed in quality
measuring system, will help an organization in the
following ways:
 One can take the error of an instrument into account while
using it and hence correct measurements are recorded and
reported .this will help an organization to set its process and
quality control system correctly.
 Wherever possible, one can adjust or repair the instrument
to minimize the error to the best extent.
 Any dispute arising with a customer due to instrument
error can be resolved.
Quality Critical Equipment
 Those items of equipment necessary to perform a testand
which have a significanteffect on the uncertainty
ofmeasurement of test results.
 The laboratory shall furnishequipment needed to perform
Quality Critical Testing for:
 Sampling
 Measurement
 Processing
 Analyzing test data
Equipment & Software
 Capable of achieving accuracy
 Complies with specifications elevant to tests
 Calibrated & checked prior to placing into service
 Meets specification requirements
 Complies with standard specifications
 Records must be kept
Equipment Needs & Documentation
 All measurement and testing equipment have a significant
effect on the validity and accuracy of test results
 All equipment that requires calibration shall be labelled,
coded, or otherwise identified to indicate the status of
calibration, including the last date of calibration and date of
expiration or due date of next calibration.
 Equipment sent out of the laboratory must be recalibrated or
checked and shown to be satisfactory before placing into
service.
 Calibration and verification takes place at specified intervals
through the use of traceable standards or appropriate reference
materials or reference cultures.
Documentation
EQUIPMENT CLASSIFICATION
 Critical equipment:
 Direct measurement that affect the final product quality.
 Measurement on critical process parameters in the
process specification.
 Non critical equipment:
 Indirect measurement that will not directly affect the
final product quality.
 Shall be maintained based on company maintenance
schedule.
CALIBRATION INTERVAL
 Depending on:
 Classification of Critical or non-critical
 Usage (light or heavy usage)
 Handling (light or heavy handling) Handling (light or
heavy handling)
 Manufacturer’s recommendation
 Reference to NIST or accreditation body guideline for a
specific measurement system
Frequency Of Instrument Calibration
14
 How often you conduct instrument calibration mainly depends
upon its tendency to drift from the true measurement and how it
impacts the quality of the end product. Examine each instrument
being used and study its behavior. Based on this information, you
can design a calibration schedule for each instrument.
 The interval between calibrations can vary as:
 Weekly
 Monthly or bi-monthly
 Quarterly, semi-annually or annually
 After every heavy usage of the instrument
When Should The Measuring Instruments Be Calibrated?
15
The frequency of calibrating the measuring instruments depends
on a number of different factors. The following is a guide
outlining when instruments need to be calibrated as a part of
GMP:
 As soon as you bring in a new instrument, you should calibrate
it before you test it out.
 Before and after you take critical measurements
 After any instance of electrical or mechanical shock or a
similar event that includes a fall, bump, etc.
 When you suspect that the accuracy of measurements
being produced is questionable
 If there were any repairs or re-qualifications of the instrument
 As per included as part of a calibration schedule
 Depending on the task and processes as some require
calibration to be conducted before the work starts
 According to the manufacturer’s recommendation
Measurement Traceability & Equipment
 All measurement and testing equipment that has a significant
effecton the validity and accuracy of test results should be
calibrated or verified at specified intervals through the use of
 traceable standards
 or appropriate reference materials
 Traceability applies to measuring and test equipment unless
youcan prove that it is a minor component of measuring
uncertainty. In this case, you must provide the uncertainty of
the instrument.
Support Equipment That Require Calibration
 Not test equipment, but includes:
 Balances
 Ovens
 Refrigerators
 Freezers
 Incubators
 Water baths
 Temperature measuring devices
 Thermal/pressure sample preparation devices
 Volumetric dispensing devices (including automatic dilutor /
dispensing devices)
 If quantitative results are dependent on their accuracy
Support Equipment
“ Do you think that we can
performproper calibration in
our Laboratory??? ”
CALIBRATION PROCESS
 There are different ways that are used to calibrate an instrument
.These methods are chosen based on the desired results of the
calibration and regulatory authorities’ requirements.
 The purpose of calibration is to ensure that the measuring
accuracy is known over the whole measurement range under
specified environmental conditions for measurement range
under specified environmental conditions for calibration.
 Calibration process must be managed and executed in a
professional manner.
Conti...
 A particular place for all calibration operations to take place
and keeping all instruments for calibration.
 A separate room is preferred because (A) better environmental
control and (B) better protection against unauthorized
handling or use of the calibration instruments.
 The performance of all calibration operations is assigned as
the clear responsibility of just one person.
 Calibration procedures, used for quality control functions, are
controlled by the international standard ISO 9000. It requires
that all persons using calibration equipment be adequately
trained.
 Standard Calibration: This method is mostly preferred for calibrating
instruments that are non-critical to quality or are not required for accreditation
and license purposes. Use traceable standards and document its performance.
 Calibration with Data: Procedures for calibrations with data are similar to
that of accredited calibration. The only exception being that these procedures
are not accredited to the ISO standard. Moreover, they are not accompanied
by data on measurement uncertainties.
 ISO 17025 Accredited Calibration: This has to be the strictest method of
calibration. Generally, it requires a measurement report which has the details
of the measurements that are made against a standard of ‘as found’ (before
calibration is started) and ‘as left’ (once the calibration is completed). If the
calibration is done by a calibration service provider, they must issue a
certificate of the same.
22
Commonly Used Calibration Methods and Procedures
PRIMARY STANDARD
 Highest accuracy order in the measurement system.
 Traceable to National or International standard.
REFERENCE STANDARD & MATERIAL
 Reference Standard
It shall be calibrated by a body that can provide traceability.
Such reference standard of measurement held by the laboratory
shall be used for calibration only. It shall be calibrated before
and after any adjustment.
 Reference Materials
Where possible, it shall be traceable to SI units of measurement,
or toCertified Reference Materials. Internal Reference Material
shall be checked as far as is technically and economically
practical.
Importance of Regular Calibration
11
 Calibration is responsible for defining the accuracy of any
measurement and its quality that is recorded by any instrument.
 When you start working with any instrument, it must be calibrated
well, thus assuring you of accurate results. However, over a
period of time you will start observing a ‘drift’. Calibration
minimizes such uncertainties by assuring the accuracy of the test
equipment.
 When you regularly calibrate your equipment, you can eliminate
the drift at its budding stage instead of allowing it to grow till it
affects the measurements in significant ways.
 Calibration helps in quantifying and controlling errors and
uncertainties within various measurement processes to an
acceptable level.
 Further, it helps in improving the accuracy of the measuring
device, which in turn improves the quality of the end product.
 In short, regular calibration allows pharmaceutical companies to
have confidence in their results which they can record, monitor
and control.
CALIBRATION IDENTIFICATION
 Status of equipment calibration shall be available and affixed
to the equipment where applicable.
 Equipment identification shall bear the following information:
 Name of equipment name of equipment
 Serial no.
 Date calibrated
 Status
 Schedule of next calibration and
 Initial/Signature of the person who performed the
calibration
OUT OF CALIBRATION
 Remove equipment from use.
 Out of Calibration Investigation to be carried out to
determine the source of inaccuracy.
 Evaluate the impact of OOC result on the final product
quality and other previously measured data.
 All investigation findings should be documented.
CALIBRATION RECORDS
 Calibration include the control of all critical measurement
equipment that contain the following details:
 Name
 Identification by model and serial
 Location
 Owner/Responsible
 Calibration Frequency
 Calibration due date
 Calibration Certificate
 Calibration Procedure
CALIBRATION CERTIFICATE
 Name and address of contracted calibration laboratory.
 Name and address of client.
 Description and identification of item calibrated.
 Environment conditions when calibration was made.
 Date of receipt of instrument, date of calibration and date of
next calibration.
 Calibration method.
 Result of calibration.
 Signature and title of person responsible for the calibration.
 External calibration contract shall be awarded to Accredited
by the nation institution.
QUALIFICATION
30
 It refers to activities undertaken to demonstrate that utilities and
equipment are suitable for their intended use and perform
properly.
 It is the action of proving that any equipment or process works
correctly and consistently and produces the expected results.
 “It is the action of proving and documenting that equipment or
ancillary systems are properly installed, work correctly, and
actually lead to the expected results.”
 Qualification is part of validation, but the individual
qualification steps alone do not constitute process
validation.
 Qualification of analytical instrumentation is essential for
accurate and precise measurement of analytical data. If the
instrumentation is not qualified, ensuring that the results
indicated are trustworthy, all other work based upon the use of
that instrumentation is suspect.
 Qualification of instruments is not a single, continuous process
but instead results from many discrete activities. For
convenience, these activities have been grouped into 4 phases of
qualification. These phases are described below
 Design Qualification (DQ)
 Installation Qualification ( IQ)
 Operational Qualification (OQ)
 Performance Qualification (PQ)
31
DESIGN QUALIFICATION
Design qualification (DQ) defines the functional and
operational specifications of the instrument and details
for the conscious decisions in the selection of the
supplier
Points to be considered for inclusion in a DQ
 Description of the analysis problem
 Description of the intended use of the equipment
 Description of the intended environment
 Preliminary selection of the functional and
performance specifications (technical, environmental,
safety)
DQ check items
 GMPs and regulatory requirements
 Performance criteria
 Reliability and efficiency
 Commissioning requirements
 Construct ability and installation of equipment
 Safety and environment impact
 Description of the intended use of the equipment
 Preliminary selection of the supplier
 Final selection of the equipment
34
INSTALLATION QUALIFICATION
Installation qualification establishes that the instrument
is received as designed and specified, that it is properly
installed in the selected environment, and that this
environment is suitable for the operation and use of the
instrument
 Equipment design features (i.e. material of construction
cleanability, etc.)
 Installation conditions (wiring, utility, functionality, etc.)
 Calibration, preventative maintenance, cleaning schedules.
 Safety features.
 Supplier documentation, prints, drawings and manuals.
 Software documented.
 Spare parts list.
 Environmental conditions (such as clean room
requirements, temperature, and humidity).
 Any problems identified in I.Q must be investigated and
appropriate actions must be taken. All such actions must be
documented and approved by higher authority.
36
IQ check items
OPERATIONAL QUALIFICATION
Operational qualification (OQ) is the process of
demonstrating that an instrument will function
according to its operational specification in the selected
environment
 Process control limits (time, temperature, pressure, line speed,
setup conditions, etc.)
 Software parameters.
 Raw material specifications
 Process operating procedures.
 Material handling requirements.
 Process change control.
 Training.
 Potential failure modes, action levels and worst-case
conditions.
 The use of statistically valid techniques such as screening
experiments to optimize the process can be used during this
phase.
 Any problems identified in O.Q must be investigated and
appropriate actions must be taken. All such actions must be
documented and approved by higher authority.
38
OQ check items
PERFORMANCE QUALIFICATION
Performance Qualification (PQ) is the process of
demonstrating that an instrument consistently performs
according to a specification appropriate for its routine
use
Conti...
 PQ considerations include:
 Actual product and process parameters and procedures established in
OQ.
 Acceptability of the product.
 Assurance of process capability as established in OQ.
 Process repeatability, long term process stability.
 It is used to 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.,
 Everyday.
 Every time the system is used.
 Before, between and after a series of runs.
 Define corrective actions on what to do if the system does not meet
the established criteria.
 Modification to, or relocation of equipment should follow
satisfactory review and authorization of the documented change
proposal through the change control procedure. This formal
review should include consideration of re-qualification of the
equipment.
 Minor changes or changes having no direct impact on final or in-
process product quality should be handled through the
documentation system of the preventive maintenance program.
41
Re – Qualification
Calibration and maintenance procedure (SOP)
 There should be a documented SOP for conducting
the calibration and preventive maintenance for
each type of instrumentation.
 The SOP for calibration must includes accuracy and
precision limits and what are the remedial actions should
be taken if this limits do not meet with each other. There
should be an authorized department to perform and
monitor calibration and maintenance.
 The SOP must contain the step by step calibration
instructions, instrumentation manual, proper calibration
procedures, provisions for adjustments, provisions for
record and document the actual measurement reading
before and after doing adjustment.
REFERENCES
 Quality Assurance guid by organization of
pharmaceutical producer of india.
 FJ Caeleton , J Agalloco , validation of pharmaceutical
process, Marcel Dekker Inc.
 M.A Podar,Pharmaceutical Quality Assurance, nirali
prakashan , pune
 Guideline on ASEAN Cosmetic GMP (2003)
 WHO Guideline For Sampling OF Pharmaceuticals and
related materials
Calibration and Qualification

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Calibration and Qualification

  • 1. Calibration and Qualification Presented By: Assistant Professor Miss.Priyanka Kandhare Dept:-Pharmaceutical Quality Assurance AISSMS COLLEGE OF PHARMACY
  • 2. CALIBRATION  “comparison of measurement system or device of unknown accuracy to another measurement system or device of known accuracy to detect, correlate report or eliminate by adjustment any variation from required performance limits of unverified measurement system or device ”  To maintain the accuracy and precision of test equipment at all times. To ensure highest level of confidence in all measurement that affect materials disposition decision, with unbroken chain of traceability to national standard.  To determine whether the equipment is still fit for its intended purpose.  This is important for justifying the processes of Qualification and Validation. 2
  • 3. Objectives  It checks the accuracy of an instrument  It determines the traceability of the measurement  provides confidence that your products /services / results meet their specifications .
  • 4. Purpose /Need Of Calibration  Components age and equipment undergoes changes in temperature or humidity or sustains mechanical stress, performance degrades. This is called drift. Then test results become unreliable. While drift cannot be eliminated, it can be detected and either unreliable. While drift cannot be eliminated, it can be detected and either corrected or compensated for through the process of calibration.  Properly calibrated equipment provides confidence that your products/services/results meet their specifications . Calibration: Optimizes resources; Ensures consistency; and Ensures measurements (and perhaps products) are compatible with those made elsewhere.  By making sure that your measurements are based on international standards, you promote acceptance of your products/services/results .
  • 5. conti... Master Instrument List -  Description or name  Unique identifier  Instrument accuracy, range, etc.  Calibration frequency  Location  Expiration or due date  Applicable calibration procedure and standards.
  • 6. Scope Of Calibration 6  To make sure that the readings of equipment or instruments are consistent with other measurements and display the correct readings every single time.  To determine the accuracy, precision, reliability and deviation of the measurements produced by all the instruments.  To establish the reliability of the instrument being used and whether it can be trusted to deliver repeatable results each time.  To map the ‘drift’ as documented. Instruments have a tendency to produce inaccurate measurements over a period of time, following repeated use.  Ensuring that the industry standards, quality assurance benchmarks such as cGMP and government regulations are adhered to.
  • 7. Advantages Of Calibration  The knowledge of the nature and extent of errors of the testing and measuring the instruments employed in quality measuring system, will help an organization in the following ways:  One can take the error of an instrument into account while using it and hence correct measurements are recorded and reported .this will help an organization to set its process and quality control system correctly.  Wherever possible, one can adjust or repair the instrument to minimize the error to the best extent.  Any dispute arising with a customer due to instrument error can be resolved.
  • 8. Quality Critical Equipment  Those items of equipment necessary to perform a testand which have a significanteffect on the uncertainty ofmeasurement of test results.  The laboratory shall furnishequipment needed to perform Quality Critical Testing for:  Sampling  Measurement  Processing  Analyzing test data
  • 9. Equipment & Software  Capable of achieving accuracy  Complies with specifications elevant to tests  Calibrated & checked prior to placing into service  Meets specification requirements  Complies with standard specifications  Records must be kept
  • 10. Equipment Needs & Documentation  All measurement and testing equipment have a significant effect on the validity and accuracy of test results  All equipment that requires calibration shall be labelled, coded, or otherwise identified to indicate the status of calibration, including the last date of calibration and date of expiration or due date of next calibration.  Equipment sent out of the laboratory must be recalibrated or checked and shown to be satisfactory before placing into service.  Calibration and verification takes place at specified intervals through the use of traceable standards or appropriate reference materials or reference cultures.
  • 12. EQUIPMENT CLASSIFICATION  Critical equipment:  Direct measurement that affect the final product quality.  Measurement on critical process parameters in the process specification.  Non critical equipment:  Indirect measurement that will not directly affect the final product quality.  Shall be maintained based on company maintenance schedule.
  • 13. CALIBRATION INTERVAL  Depending on:  Classification of Critical or non-critical  Usage (light or heavy usage)  Handling (light or heavy handling) Handling (light or heavy handling)  Manufacturer’s recommendation  Reference to NIST or accreditation body guideline for a specific measurement system
  • 14. Frequency Of Instrument Calibration 14  How often you conduct instrument calibration mainly depends upon its tendency to drift from the true measurement and how it impacts the quality of the end product. Examine each instrument being used and study its behavior. Based on this information, you can design a calibration schedule for each instrument.  The interval between calibrations can vary as:  Weekly  Monthly or bi-monthly  Quarterly, semi-annually or annually  After every heavy usage of the instrument
  • 15. When Should The Measuring Instruments Be Calibrated? 15 The frequency of calibrating the measuring instruments depends on a number of different factors. The following is a guide outlining when instruments need to be calibrated as a part of GMP:  As soon as you bring in a new instrument, you should calibrate it before you test it out.  Before and after you take critical measurements  After any instance of electrical or mechanical shock or a similar event that includes a fall, bump, etc.  When you suspect that the accuracy of measurements being produced is questionable  If there were any repairs or re-qualifications of the instrument  As per included as part of a calibration schedule  Depending on the task and processes as some require calibration to be conducted before the work starts  According to the manufacturer’s recommendation
  • 16. Measurement Traceability & Equipment  All measurement and testing equipment that has a significant effecton the validity and accuracy of test results should be calibrated or verified at specified intervals through the use of  traceable standards  or appropriate reference materials  Traceability applies to measuring and test equipment unless youcan prove that it is a minor component of measuring uncertainty. In this case, you must provide the uncertainty of the instrument.
  • 17. Support Equipment That Require Calibration  Not test equipment, but includes:  Balances  Ovens  Refrigerators  Freezers  Incubators  Water baths  Temperature measuring devices  Thermal/pressure sample preparation devices  Volumetric dispensing devices (including automatic dilutor / dispensing devices)  If quantitative results are dependent on their accuracy
  • 19. “ Do you think that we can performproper calibration in our Laboratory??? ”
  • 20. CALIBRATION PROCESS  There are different ways that are used to calibrate an instrument .These methods are chosen based on the desired results of the calibration and regulatory authorities’ requirements.  The purpose of calibration is to ensure that the measuring accuracy is known over the whole measurement range under specified environmental conditions for measurement range under specified environmental conditions for calibration.  Calibration process must be managed and executed in a professional manner.
  • 21. Conti...  A particular place for all calibration operations to take place and keeping all instruments for calibration.  A separate room is preferred because (A) better environmental control and (B) better protection against unauthorized handling or use of the calibration instruments.  The performance of all calibration operations is assigned as the clear responsibility of just one person.  Calibration procedures, used for quality control functions, are controlled by the international standard ISO 9000. It requires that all persons using calibration equipment be adequately trained.
  • 22.  Standard Calibration: This method is mostly preferred for calibrating instruments that are non-critical to quality or are not required for accreditation and license purposes. Use traceable standards and document its performance.  Calibration with Data: Procedures for calibrations with data are similar to that of accredited calibration. The only exception being that these procedures are not accredited to the ISO standard. Moreover, they are not accompanied by data on measurement uncertainties.  ISO 17025 Accredited Calibration: This has to be the strictest method of calibration. Generally, it requires a measurement report which has the details of the measurements that are made against a standard of ‘as found’ (before calibration is started) and ‘as left’ (once the calibration is completed). If the calibration is done by a calibration service provider, they must issue a certificate of the same. 22 Commonly Used Calibration Methods and Procedures
  • 23. PRIMARY STANDARD  Highest accuracy order in the measurement system.  Traceable to National or International standard.
  • 24. REFERENCE STANDARD & MATERIAL  Reference Standard It shall be calibrated by a body that can provide traceability. Such reference standard of measurement held by the laboratory shall be used for calibration only. It shall be calibrated before and after any adjustment.  Reference Materials Where possible, it shall be traceable to SI units of measurement, or toCertified Reference Materials. Internal Reference Material shall be checked as far as is technically and economically practical.
  • 25. Importance of Regular Calibration 11  Calibration is responsible for defining the accuracy of any measurement and its quality that is recorded by any instrument.  When you start working with any instrument, it must be calibrated well, thus assuring you of accurate results. However, over a period of time you will start observing a ‘drift’. Calibration minimizes such uncertainties by assuring the accuracy of the test equipment.  When you regularly calibrate your equipment, you can eliminate the drift at its budding stage instead of allowing it to grow till it affects the measurements in significant ways.  Calibration helps in quantifying and controlling errors and uncertainties within various measurement processes to an acceptable level.  Further, it helps in improving the accuracy of the measuring device, which in turn improves the quality of the end product.  In short, regular calibration allows pharmaceutical companies to have confidence in their results which they can record, monitor and control.
  • 26. CALIBRATION IDENTIFICATION  Status of equipment calibration shall be available and affixed to the equipment where applicable.  Equipment identification shall bear the following information:  Name of equipment name of equipment  Serial no.  Date calibrated  Status  Schedule of next calibration and  Initial/Signature of the person who performed the calibration
  • 27. OUT OF CALIBRATION  Remove equipment from use.  Out of Calibration Investigation to be carried out to determine the source of inaccuracy.  Evaluate the impact of OOC result on the final product quality and other previously measured data.  All investigation findings should be documented.
  • 28. CALIBRATION RECORDS  Calibration include the control of all critical measurement equipment that contain the following details:  Name  Identification by model and serial  Location  Owner/Responsible  Calibration Frequency  Calibration due date  Calibration Certificate  Calibration Procedure
  • 29. CALIBRATION CERTIFICATE  Name and address of contracted calibration laboratory.  Name and address of client.  Description and identification of item calibrated.  Environment conditions when calibration was made.  Date of receipt of instrument, date of calibration and date of next calibration.  Calibration method.  Result of calibration.  Signature and title of person responsible for the calibration.  External calibration contract shall be awarded to Accredited by the nation institution.
  • 30. QUALIFICATION 30  It refers to activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly.  It is the action of proving that any equipment or process works correctly and consistently and produces the expected results.  “It is the action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results.”  Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.
  • 31.  Qualification of analytical instrumentation is essential for accurate and precise measurement of analytical data. If the instrumentation is not qualified, ensuring that the results indicated are trustworthy, all other work based upon the use of that instrumentation is suspect.  Qualification of instruments is not a single, continuous process but instead results from many discrete activities. For convenience, these activities have been grouped into 4 phases of qualification. These phases are described below  Design Qualification (DQ)  Installation Qualification ( IQ)  Operational Qualification (OQ)  Performance Qualification (PQ) 31
  • 32. DESIGN QUALIFICATION Design qualification (DQ) defines the functional and operational specifications of the instrument and details for the conscious decisions in the selection of the supplier
  • 33. Points to be considered for inclusion in a DQ  Description of the analysis problem  Description of the intended use of the equipment  Description of the intended environment  Preliminary selection of the functional and performance specifications (technical, environmental, safety)
  • 34. DQ check items  GMPs and regulatory requirements  Performance criteria  Reliability and efficiency  Commissioning requirements  Construct ability and installation of equipment  Safety and environment impact  Description of the intended use of the equipment  Preliminary selection of the supplier  Final selection of the equipment 34
  • 35. INSTALLATION QUALIFICATION Installation qualification establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument
  • 36.  Equipment design features (i.e. material of construction cleanability, etc.)  Installation conditions (wiring, utility, functionality, etc.)  Calibration, preventative maintenance, cleaning schedules.  Safety features.  Supplier documentation, prints, drawings and manuals.  Software documented.  Spare parts list.  Environmental conditions (such as clean room requirements, temperature, and humidity).  Any problems identified in I.Q must be investigated and appropriate actions must be taken. All such actions must be documented and approved by higher authority. 36 IQ check items
  • 37. OPERATIONAL QUALIFICATION Operational qualification (OQ) is the process of demonstrating that an instrument will function according to its operational specification in the selected environment
  • 38.  Process control limits (time, temperature, pressure, line speed, setup conditions, etc.)  Software parameters.  Raw material specifications  Process operating procedures.  Material handling requirements.  Process change control.  Training.  Potential failure modes, action levels and worst-case conditions.  The use of statistically valid techniques such as screening experiments to optimize the process can be used during this phase.  Any problems identified in O.Q must be investigated and appropriate actions must be taken. All such actions must be documented and approved by higher authority. 38 OQ check items
  • 39. PERFORMANCE QUALIFICATION Performance Qualification (PQ) is the process of demonstrating that an instrument consistently performs according to a specification appropriate for its routine use
  • 40. Conti...  PQ considerations include:  Actual product and process parameters and procedures established in OQ.  Acceptability of the product.  Assurance of process capability as established in OQ.  Process repeatability, long term process stability.  It is used to 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.,  Everyday.  Every time the system is used.  Before, between and after a series of runs.  Define corrective actions on what to do if the system does not meet the established criteria.
  • 41.  Modification to, or relocation of equipment should follow satisfactory review and authorization of the documented change proposal through the change control procedure. This formal review should include consideration of re-qualification of the equipment.  Minor changes or changes having no direct impact on final or in- process product quality should be handled through the documentation system of the preventive maintenance program. 41 Re – Qualification
  • 42. Calibration and maintenance procedure (SOP)  There should be a documented SOP for conducting the calibration and preventive maintenance for each type of instrumentation.  The SOP for calibration must includes accuracy and precision limits and what are the remedial actions should be taken if this limits do not meet with each other. There should be an authorized department to perform and monitor calibration and maintenance.  The SOP must contain the step by step calibration instructions, instrumentation manual, proper calibration procedures, provisions for adjustments, provisions for record and document the actual measurement reading before and after doing adjustment.
  • 43. REFERENCES  Quality Assurance guid by organization of pharmaceutical producer of india.  FJ Caeleton , J Agalloco , validation of pharmaceutical process, Marcel Dekker Inc.  M.A Podar,Pharmaceutical Quality Assurance, nirali prakashan , pune  Guideline on ASEAN Cosmetic GMP (2003)  WHO Guideline For Sampling OF Pharmaceuticals and related materials