Analytical Instrument Qualification
AIQ is the documented evidence to prove that an instrument performs suitably for its intended purpose. The USP 32 NF 27 has come up with recent chapter on AIQ is a scientific approach and gives guidance of the following:
The approach of AIQ
The criteria to categorize the instrument for assessment of qualification needs
The extent of qualification depending upon the category of instrument
The documentation required.
AIQ, Analytical method validation, system suitability tests, and quality control check samples are described as the four critical components involved in the generation of reliable and consistent data.
It is the responsibility of user to prepare a User Requirement Specification (URS) which would suffice all the needs as per the requirement for analysis. The manufacturer shall be responsible for preparing the design specification.
Categorization of the instruments:
As per the USP all the laboratory instruments can be categorized into A, B and C classes depending upon the following criteria:
1. Class A: instruments with no measurement capability or usual requirement for calibration e.g. Magnetic stirrer.
2. Class B: standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturer's specification of functionality and operational limits e.g. Balance.
3. Group C: instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specific for the analytical application e.g. HPLC
The extent of qualification depends on its intended applications, criticality and manufacturer recommendation. Qualification can be carried out by modular or holistic approach.
Qualification can be divided into three phases:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Design qualification is the documented evidence that the functional and operational specification of the instrument are as per the user requirement specification and the design of the instrument is appropriate for the intended use of the customer / user. Also the DQ is to ensure that appropriate quality standards have been maintained while manufacturing and delivering the instrument. The DQ phase may include testing like FAT, SAT etc. It is the sole responsibility of user to ensure that COTS instruments are suitable for the intended use.
Installation Qualification is the documented evidence that the instrument is delivered as per the design, installed properly and the environment is suitable for the installation of the instrument. It may include the verification of make, model, serial number, diagnostic tests, environmental parameters check and installation of the instrument as per the IQ procedure.
Operational Qualification is the documented evidence that the instrument is operating according to specifications in the installed environment. Following checks can be used to verify the operational qualification phase:
Instrument operation as per the procedure
Functional key verification
Alarm and interlock verification
Safety features verification
PLC verification
Safe mode and power failure mode verification
Performance Qualification is the documented evidence that the instrument performs or gives expected out put when installed and operated as per the procedure at suitable site and the data generated is consistent and reliable.
Following checks can be used to verify the performance qualification phase:
System Suitability Test (SST)
Sample analysis
Precision
Calibration
Software validation: Software used in the analytical instrument may range from simple firmware to 21 CFR compliant control acquisition and processing software. Software validation may vary depending upon the type and intended purpose of software. As a rule of thumb Qualification of instrument (DQ, IQ, OQ, PQ) itself is the evidence of software validation. Nevertheless the extent of software validation may differ from instrument to instrument as per the regulatory requirements. The 21 CFR part 11 compliance may require a detailed and thorough software validation of electronics records and electronic signatures which may include different user levels access control, user administration, system policies, user privileges, audit trails and backup.
The frequency of qualification (requalification) may be:
Need based as in case of relocation, major breakdown or repair, change of major accessories or parts.
Time base – a timed event like every 2 / 3 years depending upon the ruggedness and criticality of the instrument.
The AIQ should be well documented as per the pre-approved protocol and any changes or deviations observed during qualification should be documented and approved prior to closure or post approval of the document.
Validation is “Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes."(FDA 1987).
AIQ is the documented evidence to prove that an instrument performs suitably for its intended purpose. The USP 32 NF 27 has come up with recent chapter on AIQ is a scientific approach and gives guidance of the following:
The approach of AIQ
The criteria to categorize the instrument for assessment of qualification needs
The extent of qualification depending upon the category of instrument
The documentation required.
AIQ, Analytical method validation, system suitability tests, and quality control check samples are described as the four critical components involved in the generation of reliable and consistent data.
It is the responsibility of user to prepare a User Requirement Specification (URS) which would suffice all the needs as per the requirement for analysis. The manufacturer shall be responsible for preparing the design specification.
Categorization of the instruments:
As per the USP all the laboratory instruments can be categorized into A, B and C classes depending upon the following criteria:
1. Class A: instruments with no measurement capability or usual requirement for calibration e.g. Magnetic stirrer.
2. Class B: standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturer's specification of functionality and operational limits e.g. Balance.
3. Group C: instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specific for the analytical application e.g. HPLC
The extent of qualification depends on its intended applications, criticality and manufacturer recommendation. Qualification can be carried out by modular or holistic approach.
Qualification can be divided into three phases:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Design qualification is the documented evidence that the functional and operational specification of the instrument are as per the user requirement specification and the design of the instrument is appropriate for the intended use of the customer / user. Also the DQ is to ensure that appropriate quality standards have been maintained while manufacturing and delivering the instrument. The DQ phase may include testing like FAT, SAT etc. It is the sole responsibility of user to ensure that COTS instruments are suitable for the intended use.
Installation Qualification is the documented evidence that the instrument is delivered as per the design, installed properly and the environment is suitable for the installation of the instrument. It may include the verification of make, model, serial number, diagnostic tests, environmental parameters check and installation of the instrument as per the IQ procedure.
Operational Qualification is the documented evidence that the instrument is operating according to specifications in the installed environment. Following checks can be used to verify the operational qualification phase:
Instrument operation as per the procedure
Functional key verification
Alarm and interlock verification
Safety features verification
PLC verification
Safe mode and power failure mode verification
Performance Qualification is the documented evidence that the instrument performs or gives expected out put when installed and operated as per the procedure at suitable site and the data generated is consistent and reliable.
Following checks can be used to verify the performance qualification phase:
System Suitability Test (SST)
Sample analysis
Precision
Calibration
Software validation: Software used in the analytical instrument may range from simple firmware to 21 CFR compliant control acquisition and processing software. Software validation may vary depending upon the type and intended purpose of software. As a rule of thumb Qualification of instrument (DQ, IQ, OQ, PQ) itself is the evidence of software validation. Nevertheless the extent of software validation may differ from instrument to instrument as per the regulatory requirements. The 21 CFR part 11 compliance may require a detailed and thorough software validation of electronics records and electronic signatures which may include different user levels access control, user administration, system policies, user privileges, audit trails and backup.
The frequency of qualification (requalification) may be:
Need based as in case of relocation, major breakdown or repair, change of major accessories or parts.
Time base – a timed event like every 2 / 3 years depending upon the ruggedness and criticality of the instrument.
The AIQ should be well documented as per the pre-approved protocol and any changes or deviations observed during qualification should be documented and approved prior to closure or post approval of the document.
Validation is “Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes."(FDA 1987).
Very useful details
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