NACO –NARI GLP Training Workshop

The history of GLP

The formal, regulatory, concept of “Good Laboratory Practice”

(GLP) originated in the USA in the 1970s

Test facilities revealed instances of inadequate planning and

incompetent execution of studies, insufficient documentation of
methods and results, and even cases of fraud. For example,
replacing animals which had died during a study with new ones
without documenting this fact, changing raw data in order to “fit
the result tables” in the final report,
What is GLP?

Good Laboratory Practice is defined as “a quality system

concerned with the organisational process and the conditions
under which non-clinical health and environmental safety
studies are planned, performed, monitored, recorded, archived
and reported
The Principles may be considered as a set of standards for
ensuring the quality, reliability and integrity of studies, the
reporting of verifiable conclusions and the traceability of data.
A Degree of excellence or a state
free from defects ,deficiencies and
significant variation
 Quality Assurance

Definition: - QA is defined as the overall program that ensures

that the final results reported by the laboratory are correct.

Quality Control:
Definition: systematic procedures in the laboratory that
must be undertaken for each assay run to verify that the test
is working properly.
.
The aim of quality control is simply to ensure that
the results generated by the test are correct.
However, quality assurance is concerned with much
more: that the right test is carried out on the right
specimen, and that the right result and right
interpretation is delivered to the right person at the
right time”
Quality Assessment - quality assessment
(also known as proficiency testing) is a means
to determine the quality of the results
generated by the laboratory. Quality
assessment is a challenge to the effectiveness
of the QA and QC programs.

Quality Assessment may be external or

internal, examples of external programs
include NEQAS,
 QA=IQC+EQA

Internal Quality Control:

Definition:
Set of procedures undertaken by laboratory staff for the
continuous monitoring of operation and the results of
measurements in order to decide whether results are
reliable enough to be released
Objectives:

1.Prevent failure of assay

2.Identify problem

3.Initiate course of action

4.Increase efficiency and

5.Eliminate rework
Internal Quality Control Includes:-

• Personal File :-
Components of personal file:
1. Biodata
2. Educational qualification
3. Employment details
4. Training Log
5. Institute training
6. Certificates of training attended
7. Job responsibility
8. Competency assessment
9. Continuing education
10.Vaccination
 Newly joined staff should be trained for the necessary
techniques of the laboratory.
 The training log are signed and dated by supervisor and
trainee, and filed in the personal file.
 Specialized Training course
3. Competency Assessment

Definition: ability of personal to give expected result with the std one

Should be carried out after training

Ten samples should be stained :

(two samples from healthy HIV seronegative and eight from HIV seropositive
individuals) by the new staff in parallel with competent staff.

% variation= (Observed/Expected x 100)-100

variation between the results should not exceed ±20%. (Result should
documented in Appendix-I)

Competency should be carried out six month and there after annually.

For competency assessment two external proficiency sample should stain and
result should assess as per external agency result. (Result should be documented
in Appendix-II)
 Sr No. Date Ab %CD3 Ab %CD4 Ab %CD8 CD4/CD8
CD3 CD4 CD8
1- CS

1-Trainee

%Variation

2-CS

2-Trainee

%Variation

3- CS

3-Trainee

%Variation

CS: Competant staff.

Name of the staff: Date of processing:
Instrument used: Trial No.:
Sample No.:

Parameters Values QASI results Remark

obtained Mean 2 S.D.

CD3 Abs
CD3%
CD4 Abs
CD4%
CD8 Abs
CD8 %
Signature: Reviewed by:
4. Internal Quality Assurance:

a. IQC samples:
i) Commercially available Stabilized blood

ii) In house-Previous day tested sample

Two patients’ samples acquired on the previous day with high and
low CD4 values can be selected as controls.

These samples will be stained and acquired along with the other
samples.

The results of these QC samples on both the days should be entered

in the log (Appendix IV).

The acceptable variation between the results is ±20%.

 Sample Id. DATE Abs. CD3 %CD3 Abs. CD4 %CD4 Abs. CD8 %CD8 Sign Remarks

1. 5/5/10
(High CD4
value)
6/5/10

% Variation

2. 5/5/10
(Low CD4
Value)
6/5/10

% Variation

Signature: Reviewed by:

b. Lot to Lot Variation:

Stain two samples, one from a healthy HIV seronegative individual and
second from HIV infected patient, with both the lot of reagents.

Reproducibility is checked and entered in Quality Control log for lot to

lot variation of respective instrument.(Appendix-V)

Acceptable variation between the results obtained from both the lot of
reagents is ±20%.

The quality control procedures and logs are monitored and signed by
the laboratory supervisor
Sr. Id. No. Acce Dt. of Reag. Reag. Reag. Abs CD3 Abs. CD4 Abs. CD8 Remark Tech. Sign
No. ssio proce Name Lot Exp. CD3 % CD4 % CD8 % Initia
n ssing ls
No.

1 Pos OL

NL

% Variation

Sr. Id. No. Acce Dt. of Reag. Reag. Reag. Abs CD3 Abs. CD4 Abs. CD8 Remark Tech. Sign
No. ssio proce Name Lot Exp. CD3 % CD4 % CD8 % Initia
n ssing ls
No.

2 Neg OL

NL

% Variation

Signature: Reviewed by:

c. Reporting of results:

Accurate result with QC done and reviewed by supervisor

is important

Wrong results affect on patients treatment

d. Data backup:

data back is a very Important part of the quality assurance

program.

Store on CD/ Hard disk

should not store in same Lab/ building

Thank You

Thank
You