Calibration And Qualification Of Equipm
CALIBRATION AND
QUALIFICATION OF
EQUIPMENT
Dr. Lakshmi M Sundar, M. Pharm
Ph.D
NIPER-Gandhinagar,
Gujarat, India
CALIBRATION AND QUALIFICATION
Introduction
Definitions
Regulations and guidelines
Analytical instrument Qualification
Types of Instruments
Calibrations of instruments (few examples) PA-510
Chapter-7
2
ANALYTICAL INSTRUMENT QUALIFICATION (AIQ)
Introduction:
Wide range of equipment used in pharmaceutical industry to acquire data
Analyst - obtain reliable and valid data suitable for intended use
Ensure that the products are suitable for intended use
PA-510
Chapter-7
3
COMPONENTS OF DATA QUALITY
Four critical components of data quality
Quality
control check System suitability test
Analytical Method
Validation
Analytical Instrument
Qualification
PA-510
Chapter-7
4
COMPONENTS OF DATA QUALITY
Analytical Instrument Qualification
(AIQ):
Collection of documented evidence that an instrument performs suitably for its intended purpose
Analytical Method Validation:
Collection of documented evidence that an analytical procedure is suitable for its intended purpose
PA-510
Chapter-7
5
COMPONENTS OF DATA QUALITY
System Suitability Checks:
Tests to verify that the system will perform in accordance with the criteria set forth in the procedure
Quality control check samples:
Tests on instruments using reference materials and/or calibration standards for an in-process and ongoing assurance of tests performance
PA-510
Chapter-7
6
ANALYTICAL INSTRUMENTS
Analytical devices are termed as instruments and equipment, which are used interchangeably
Instrument: A device used to collect data and measurement of results e.g., UVVisible spectrophotometer
Equipment: Support device used for performing analysis in the laboratory
e.g., centrifuge
PA-510
Chapter-7
7
CALIBRATION
Calibration is defined as the set of operations which establish, under specified conditions, the relationship between
QUALIFICATION OF
EQUIPMENT
Dr. Lakshmi M Sundar, M. Pharm
Ph.D
NIPER-Gandhinagar,
Gujarat, India
CALIBRATION AND QUALIFICATION
Introduction
Definitions
Regulations and guidelines
Analytical instrument Qualification
Types of Instruments
Calibrations of instruments (few examples) PA-510
Chapter-7
2
ANALYTICAL INSTRUMENT QUALIFICATION (AIQ)
Introduction:
Wide range of equipment used in pharmaceutical industry to acquire data
Analyst - obtain reliable and valid data suitable for intended use
Ensure that the products are suitable for intended use
PA-510
Chapter-7
3
COMPONENTS OF DATA QUALITY
Four critical components of data quality
Quality
control check System suitability test
Analytical Method
Validation
Analytical Instrument
Qualification
PA-510
Chapter-7
4
COMPONENTS OF DATA QUALITY
Analytical Instrument Qualification
(AIQ):
Collection of documented evidence that an instrument performs suitably for its intended purpose
Analytical Method Validation:
Collection of documented evidence that an analytical procedure is suitable for its intended purpose
PA-510
Chapter-7
5
COMPONENTS OF DATA QUALITY
System Suitability Checks:
Tests to verify that the system will perform in accordance with the criteria set forth in the procedure
Quality control check samples:
Tests on instruments using reference materials and/or calibration standards for an in-process and ongoing assurance of tests performance
PA-510
Chapter-7
6
ANALYTICAL INSTRUMENTS
Analytical devices are termed as instruments and equipment, which are used interchangeably
Instrument: A device used to collect data and measurement of results e.g., UVVisible spectrophotometer
Equipment: Support device used for performing analysis in the laboratory
e.g., centrifuge
PA-510
Chapter-7
7
CALIBRATION
Calibration is defined as the set of operations which establish, under specified conditions, the relationship between
References: Indian Pharmacopoeia, 2007, Vol-I, The Indian Pharmacopoeia