Analytical Instrument Qualification

2. QUALIFICATION OF
INSTRUMENT
Presented To
Sir Umer Younas
Presented By
Rai Shahzad Noshair
BSCHEM01191011 [A]

3. CONTENTS:
• Definition
• Objective and goals
• Components of data quality
• Qualification phases
i. Design Qualification (QD)
ii. Installation Qualification (IQ)
iii. Operational Qualification (OQ)
iv. Performance Qualification (PQ)
• Significance

4. DEFINATION:
Analytical instrument qualification (AIQ) is documented evidence that
an instrument performs suitably for its intended purpose and it is
properly maintained and calibrated.[1]

5. Objective and goals
• Ensure that the quality products manufactured
• Easy maintenance of instrument and safety
• To improve overall production reliability and availability
• Control of product quality
• Reduction of variation in results
• Fewer interuptions of work

6. Components of data quality
• Analytical instrument qualification helps justify the continued use of
equipment, but it alone does not ensure the quality of data. Analytical
instrument qualification is 1 of the 4 critical components of data
quality. Figure shows these components as layered activities within a
Quality Triangle. Each layer adds to the overall quality. Analytical
Instrument Qualification forms the base for generating quality data.

7. Types of Qualification :
There are four phase of instrument qualification
Design Qualification (QD)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)

9. DESIGN QUALIFICATION (DQ)
• Design qualification (DQ) is the documented collection of activities
that define the functional and operational specifications of the
instrument and criteria for selection of the vendor, based on the
intended purpose of the instrument.
• Begins at vender side
• Instrument is developed, designed and produced in a validate
environment according to the GLP, CGMP, ISO 9000 standards.
• Describe the user requirement.
• DQ tells about instrument, enable for suitable operation or not.[2]

10. INSTALLATION QUALIFICATION:
• Installation qualification is a documented collection of activities need
to install an instrument in the user’s environment.
• System description
• Utilities/Facilities/environment
• Network & Data Storage
• Assembly & Installation
• Installation verification[3]

11. OPERATIONAL QUALIFICATION
• After a successful IQ the instrument is ready for next OQ testing.
• OQ includes procedures and documentation of OQ of analytical
instrument.
• When all procedures are executed and all items pass the inspection, it
is verify that system operates to satisfy the intended purpose.
OP include these parameters
• Fixed parameters
• Secure Data Storage, Backup & Archive
• Instrument Function tests

12. PERFORMANCE QUALIFICATION (PQ)
Once an IQ and OQ have been performed, PQ testing is conducted.
The objective is to ensure that the instrument is perfoming within specified
limits.
PQ include:
• Performance checks
• Preventive Maintenance & Repairs
• Standard Operating Procedure for:
Operation
Calibration
Maintenance [4]

13. Significance
• Provide scientific information about instrument and improve safety.
• To improve overall production reliability and availability
• Ensure that the quality products manufactured

14. References
1. Laboratory Controls, General Requirements, Code of Federal Regulations, Part 211.160,
Title 21, Rev. April 2000.
2. Maintenance and Calibration of Equipment, Code of Federal Regulations, Part 58.63,
Title 21, Rev. April 2000.
3. Anjaneyulu Y, Marayya R, Quality Assurance and Quality Management in
Pharmaceutical industry, Pharmabook Syndicate, 2005.
4. International Conference on Harmonization, Harmonized Tripartite Guideline, Validation
of Analytical Procedures, Text and Methodology, Q2(R1), Nov. 2005.

15. THANK
YOU