This document discusses the qualification of gas chromatography. It begins with an introduction to gas chromatography and its use in analytical chemistry. It then discusses the different types of qualifications including design qualification, installation qualification, operational qualification, and performance qualification. Design qualification ensures the instrument is designed properly. Installation qualification confirms proper installation. Operational qualification verifies the instrument operates as expected through tests of precision, accuracy, and other parameters. Performance qualification examines the instrument's ability to provide expected results. The document provides details on tests and acceptance criteria for each qualification type to ensure the gas chromatography instrument is functioning as intended.

1. QUALIFICATION OF GAS CHROMATOGRAPHY
Submitted to:
Dr. R S CHANDAN
ASSOCIATE.PROFESSOR
Pharmaceutical Chemistry
JSS College Of Pharmacy, Mysuru
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Submitted by:
N.Surendra chowdary
M.Pharm, 1st Year
Pharmaceutical Analysis.
JSS College Of Pharmacy, Mysuru

2. CONTENTS:
• Introduction to gas chromatography
• Qualification of GC
• Design qualification
• Installation qualification
• Operational qualification
• Performance qualification
• References
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3. INTRODUCTION
• Gas chromatography (GC), is a common type of chromatography used in
analytical chemistry for separating and analyzing compounds that can be
vaporized without decomposition.
• GC is the technique of choice for the separation of thermally stable and
volatile organic and inorganic compounds.
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4. GC instrument GC inlet GC column
4

5. What is qualification ?
5
• It is a documented evidence that premises, systems, equipment's are able to
achieve the predetermined specifications ,properly installed or working
correctly and leads to expected results is called qualification.

6. DESIGN QUALIFICATION:
• Supplier must provide documented evidence that the product has been
designed, developed and manufactured in a quality environment e.g. ISO
9001:2000 certification.
• Supplier must provide phone and on-site support in case of defects.
• Supplier must provide information through the internet on availability of
new firmware upgrades.
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7. INSTALLATION QUALIFICATION:
• Equipment is compared as received with purchase order, including software,
accessories, spare parts and consumables.
• Documentation checked for completeness of operating, maintenance instructions,
standard operating procedures for testing and safety.
• Equipment is checked for any damage.
• The supplier’s instruction for installation is read.
• The supplier’s safety instructions are read.
• Hardware (computer, equipment, fittings and tubing's for fluid connections,
power cables, data flow and instrument control cables) is installed by following
the manufacturer’s recommendation.
• The instruments are switched on and ensured that all modules power up and an
electronic self test is performed.Any deviations are recorded.
• Software is installed on computer by following the manufacturer’s recommendation.
• Correct software installation is verified.
• Abackup copy of software is made.
• Peripherals e.g. printers and equipment modules are configured.

8. %Relative standard deviation(%RSD) ?
Trail. No 1 2 3 4
Retention time
Or Peak area
12.3 11.9 12.0 12.2
%RSD = MEAN DEVIATION ×100
MEAN VALUE
MEAN VALUE = SUM OF OBSERVATIONS =
TOTAL NO OF OBSERVATIONS
12.3+11.9+12.0+12.2 = 12.1
4
DEVIATION VALUE = ACTUAL VALUE –MEAN VALUE = 12.3-12.1 = 0.2
11.9-12.1 = 0.2
12.0-12.1 = 0.1
12.2-12.1 = 0.1
MEAN DEVIATION = SUM OF DEVIATION VALUES
TOTAL NO OF VALUES
= 0.2+0.2+0.1+0.1 = 0.15
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%R.S.D = 0.15 ×100 = 1.04%
12.1

9. OPERATIONALQUALIFICATION:
Precision of peak retention times
Test procedure Acceptance limits Test frequency
• Five injections of a
standard.
• Calculation of relative
standard deviation.
<1% RSD (Relative
Standard Deviation)
Yearly
Precision of peak areas
Testprocedure Acceptance limits Test frequency
• Five injections of a
standard.
• Calculation of relative
standard deviation.
<2% RSD (Relative
Standard Deviation)
Yearly

10. Accuracy of the temperature of the column oven
Test procedure Acceptance
limits
Test frequency Remarks
Temperature in column
oven is measured and
compared with setpoint.
±1°C Yearly The temperature
measurement device
should be calibrated
and traceable to a
national standard.
Precision of heated zone temperature
Test procedure Acceptanc
e limits
Test frequency Remarks
Actual temperature is
measured andcompared
with setpoints at 50,70
and 90°C
±2°C Yearly The temperature
measurement device
should be calibrated and
traceable to a national
standard.

11. Carryover of injection
Test
procedure
Acceptance limits Test frequency
Blank solvent is
injected after
standard. Peak
ratio is measured
between blank
and standard
injection.
<5% Yearly
Carryover is the appearance of a small sample peak(broad or hump like)
when injecting a blank after the sample. It is caused by sample residues
which remained in the system after the preceding injection.

12. PERFORMANCE QUALIFICATION:
Detector Linearity
Detector Linearity solutions :
Solution A 10ml of methanol ,ethanol , acetone make up to 100ml with ethyl acetate
Solution B 15ml of methanol ,ethanol , acetone make up to 100ml with ethyl acetate
Solution C 20ml of methanol ,ethanol , acetone make up to 100ml with ethyl acetate
Solution D 25ml of methanol ,ethanol , acetone make upto 100ml with ethyl acetate
Solution E 30ml of methanol ,ethanol , acetone make upto 100ml with ethyl acetate

13. Procedure Acceptance criteria
• Blank is injected followed by ‘detector
linearitysolutions’and the peak
responses are recorded.
• A standard plot is drawn between the
concentrations vs the peak responses.
The plot should be linear and
regression coefficient (R2) should
not be less than 0.99.
Concentration (mg/L) Peak-area
18.7 164217200
36.7 326917280
45.1 405326560
53.3 444601600
61.5 485037600
Regression coefficient 0.99
Accepted/ Not Accepted Accepted
For example :
concentration
P
e
a
k
A
r
e
a

14. Detector noise and Drift test:
Noise is defined as the signal change output by detector when no solute passes
through the detector, denoted by Nd
（a)Short noise
（b)Long noise
（c)Drift

15. Procedure :
• After GC is ready, the system is run up to 15 minutes through single run.
• When the run is completed noise and drift is calculated through
software.
• The acceptance values are:
a) Noise not more than 100µV.
b)Drift not more than 2500µV/hr.

16. Flow rate accuracy:
• The digital flow meter is connected to the detector outlet port.
• The carrier gas flow is set and wait till it reaches the set flow.
• The observed flow in replicate is noted.
• The procedure is repeated for other carrier gases such as
hydrogen and air.
Acceptance
• The flow rate of carrier gas should be ±10% of set flow

17. System precision:
• 20ml of methanol, ethanol and acetone is transferred into 100ml
volumetric flask and make up with ethyl acetate.
• Blank is injected followed by standard preparation in six replicates.(inject the
above solution six times in same volumes)
• The areas and retention times are noted down.
• Calculate the %RSD for retention time and peak area.
• Acceptance
• %RSD for retention time is not more than 1%
• %RSD for peak area is not more than 5%

18. REFERENCES :
• Vinod D. Usnale, Rohit D , Pooja P. Dahale , Vijay R. Chakote. a review: qualification of
analytical instrument ( differential scanning colorimetry & gas chromatography)
2022,vol24:93-111
• Surendra K. Bansal,Thomas Layloff, Ernest D. Bush, Qualification of Analytical Instruments
for Use in the Pharmaceutical Industry: A Scientific Approach .January 20, 2004
• Devesh Kapoor , Ruchi B. Vyas, Diwaker Dadrwal. An overview of analytical instrument
qualification with reference of pharmaceutical industry.2018, 8(5):99-103
• Basics & Fundamentals Gas Chromatography
• Gas Chromatography Fundamentals Agilent
• Dr. Ramon Companyó and Dr. Montserrat Llauradó. “Verification and Maintenance of
Analytical Instruments According to ISO/IEC 17025 Standard

19. THANK YOU