Qah 062 04 Procedure of Data Review

PURE & CURE HEALTHCARE PVT. LTD.
HARIDWAR
QUALITY ASSURANCE
RESTRICTED CIRCULATION
STANDARD OPERATING PROCEDURE
Title: Procedure of Data Review
Department : QA
SOP No.: QAH/062
Effective Date :
Revision No.: 04 Revision Date :
Supersede Revision 03 Page No.: 1 of 7
No.:
1.0 OBJECTIVE:
To lay down a procedure of Data Review.
2.0 SCOPE:
This SOP is applicable for Procedure of Data Review in quality control and quality assurance
department at Pure & Cure Healthcare Pvt. Ltd., Haridwar.
3.0 RESPONSIBILITY:
Operating Person: QA & QC
4.0 ACCOUNTABILITY:
Head QA
5.0 ABBREVIATIONS:
AR No. Analytical Reagent No.
COA Certificate of analysis
Exp: Expiry
Mfg: Manufacturing
NC Non compliance
No. Number
ID No. Identification number
OOS Out of specification
OOT Out of trend
QA Quality Assurance
QC Quality Control
Qty. Quantity
RT Retention time
STS Standard test specification
STP Standard testing procedure
6.0 PROCEDURE:
6.1 Procedure for Review Analytical Raw Data and COA:
6.1.1 Check Product Name, Batch No., Mfg. Date, Exp Date, Batch Size, Pack Size, Sample Qty.,
Mfg. for and AR No. in COA match with Sample/Intimation.
Prepared By Reviewed By Approved By Authorized By
Sign
Date
Nam
e
FORMAT No.: QAH-119/F01-03
HARIDWAR
QUALITY ASSURANCE
Department : QA
SOP No.: QAH/062
Effective Date :
No.:
6.1.2 Check the All testing parameters in COA are as per STS.
6.1.3 Check all testing parameters performed as per STP.
6.1.4 Check the manufacturing License No. As per Sample.
6.1.5 Check the instrument ID, Date of Calibration and Due Date filled in Raw data Sheet.
6.1.6 Check the weight prints for related tests placed on raw data sheet.
6.1.7 Check calculations are correct for related test parameter.
6.1.8 Check date and signature of analyst and checked by put on raw data sheet and COA.
6.1.9 Check signature of analyst put on at weight print of raw data sheet.
6.1.10 Check all prints of Sequence checked.
6.1.11 Do the chromatograms of Sequence match with the respective specimen chromatograms.
6.1.12 Check the RT of the principal peak within acceptance criteria.
6.1.13 Check that data file numbering is as per SOP of respective instruments.
6.1.14 Check system suitability parameters are checked and as per STP.
6.1.15 Check the Chromatographic condition checked for HPLC chromatographs.
6.1.16 Check Information entered related to analysis correct naming, Batch No/AR No.
6.1.17 Check wave length, injection volume, flow rate RT correct as per STP.
6.1.18 Check Bracketing standard inserted as per QC SOP-Good Chromatographic Practices.
6.1.19 Check correct methods file copied to sequence and applied for respective samples.
6.1.20 Check chromatograph hard copy with soft copy in instrument for data integrity verification.

Sign
Date
Nam
e
HARIDWAR
QUALITY ASSURANCE
Department : QA
SOP No.: QAH/062
Effective Date :
No.:
6.1.21 Verify that peaks are integrated as per parameters specified in STP.
6.1.22 During analysis if any testing parameter i, e. Disintegration test, dissolution test, Assay,
Related substance and uniformity of content found not complies with specification, OOS to
be raise as per SOP.
6.1.23 During review of the data any discrepancy found in raw data /COA i.e, Wrong B. No., RT
change, chromatographic condition change, calculation and print back dated chromatograms
incident file with Non compliance form.
6.1.24 Ensure that Class A glass wares used during analysis by analyst which shall be traceable with
their certificates.
6.1.25 Balances should be installed on anti vibration table with level maintained. Ensure desiccant is
blue colored.
6.1.26 In Dissolution test ensure area should be proper maintained as per Check list.
6.1.26.1 Water level of water bath should be as per mark.
6.1.26.2 Instrument Card, cleaning status label should be proper.

6.1.26.3 Calibration status label should be as per QC SOP- Receipt, Usage,
Maintenance and Disposal of Quality Control Instruments.
6.1.26.4 Product shall be analyzed as per STP.
6.1.26.5 Analyst and section head should be ensure dissolution test perform as per STP.
6.2 Environmental and Personal Safety:
6.2.1 During handling of hazardous chemicals analyst must use Wear safety goggles, Acid
resistance gloves and Nose Mask etc.
6.2.2 During spillage of the hazardous chemicals use spillage kit and MSDS of chemical.
6.3 Audit Trial Check as per below Check List:

6.3.1 Check the on line status in Run sample Serial number, vial no., Injection volume, No. of

Sign
Date
Nam
e
HARIDWAR
QUALITY ASSURANCE
Department : QA
SOP No.: QAH/062
Effective Date :
No.:
injection, Sample name, Function (For –Blank Injection control, sample-injection sample,
Std.-Injection standard,).
6.3.2 Section Head /Reviewer check Method set /Report method, Run time, Next injection delay.
6.3.3 Section head /Reviewer check the sample set – Name, No. of injection, Run mode, system
suitability, acquired by, Project name.
6.3.4 Physically check the system by the section head /Reviewer .Section head ensure the correct
standard vial put into the system on the right place and for the verification system suitability
parameter. Check the vial No., method set, Injection volume, run time etc.
6.3.5 Section head /Reviewer ensure that the detector Parameter/Instrument Parameter and
composition of mobile phase, Gradient profile as per STP. lamp on, sample rate, auto zero on
injection start , comment ,wavelength mode (single /Duel) Flow rate ,Temperature(column
tem., sample temp.)
6.3.6 Section head /Reviewer check the Modified instrument method. Why should be change the
method and deviate the method out of STP. Provide the reason and fill the modification form.
6.3.7 Section Head /Reviewer ensure, that analyst cannot modified the sample method.
6.3.8 Method creation by the section head /Reviewer only and not to provide the privilege to the
analyst.
6.3.9 Create result by the analyst analysis result match the acquired date and match with the
processing date. Section head /Reviewer should be ensure with the hard copy of
chromatogram and match with the soft copy in the system (No change the parameter
Threshold value, height, width, etc.
7.0 ANNEXURES:
ANNEXURE
TITLE OF ANNEXURE FORMAT NO.
NO.
Check List For Review Analytical Raw Data And
Annexure - I QAH-062/F01-02
COA
ENCLOSURES: SOP Training Record
8.0 DISTRIBUTION:

Sign
Date
Nam
e
HARIDWAR
QUALITY ASSURANCE
Department : QA
SOP No.: QAH/062
Effective Date :
No.:
 Controlled Copy 01 Quality Assurance

 Controlled Copy 02 Quality Control
 Master Copy Quality Assurance
9.0 REFERENCES:
GLP Manual and QC SOP- Access Control Policy for Laboratory Instruments/Equipments &
Software’s
10.0 REVISION HISTORY:
CHANGE HISTORY LOG
Revision Change Details of Changes Reason for Effective Updated
No. Control No. Change Date By
1. Point No. 6.1.13 “Check
that data file numbering is
as per SOP of respective 18/03/20 Sanjeev
instruments” & 6.1.21, For better
CC/H - “Verify that peaks are clarity & to
03
G/QA/20/0254 integrated as per parameters avoid any non-
specified in STP” has been compliance
incorporated.
2. Annexure I has been
revised
CC/H -
04 Prepared By to be removed For betterment Santosh
G/QA/21/0009

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Date
Nam
e
HARIDWAR
QUALITY ASSURANCE
Department : QA
SOP No.: QAH/062
Effective Date :
No.:
ANNEXURE I
HARIDWAR
QUALITY ASSURANCE
CHECK LIST FOR REVIEW ANALYTICAL RAW DATA AND COA
Parameter Remark
1. Is Check Product Name, Batch No., Mfg. Date ,Exp Date, Batch Size, Pack Size ,
Sample Qty., Mfg. for and AR No. in COA match with Sample/Intimation
2. Is Check the All testing parameters in COA are as per STS.
3. Is Check all testing parameters performed as per STP.
4. Is Check the manufacturing License No. As per Sample.
5. Is Check the instrument ID, Date of Calibration and Due Date filled in Raw data
Sheet
6. Is Check the weight prints for related tests placed on raw data sheet.
7. Is Check calculations are correct for related test parameter.
8. Is Check date and signature of analyst and checked by put on raw data sheet and
COA.
9. Is Check signature of analyst put on at weight print of raw data sheet.
10. Is Check all prints of sequence checked.
11. Is Do the chromatograms of Sequence match with the respective specimen
chromatograms
12. Is Check the RT of the principal peak within acceptance criteria.
13. Is Check system suitability parameters are checked as per STP.
14. Is Check the Chromatographic condition checked for HPLC chromatographs
15. Is Check that data file numbering is as per SOP of respective instruments.
16. Is Check that peaks are integrated as per parameters specified in STP.
a. Is Check Information entered related to analysis correct naming, Batch No/AR No.
Sign
Date
Nam
e
HARIDWAR
QUALITY ASSURANCE
Department : QA
SOP No.: QAH/062
Effective Date :
No.:
b. Is Check wave length, injection volume, flow rate RT correct as per STP.
c. Is Check Bracketing standard inserted as per SOP
d. Is Check correct method file copied to sequence and applied for respective samples.
e. Is Check chromatograph hard copy with soft copy in instrument for data integrity
verification.
Checked By:
FORMAT NO.: QAH-062/F01-02 Page X of Y

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Date
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PURE & CURE HEALTHCARE PVT. LTD.

6.1.4 Check the manufacturing License No. As per Sample.

6.1.7 Check calculations are correct for related test parameter.

6.1.10 Check all prints of Sequence checked.

6.1.12 Check the RT of the principal peak within acceptance criteria.

6.1.15 Check the Chromatographic condition checked for HPLC chromatographs.

6.1.18 Check Bracketing standard inserted as per QC SOP-Good Chromatographic Practices.

Prepared By Reviewed By Approved By Authorized By

6.1.26.1 Water level of water bath should be as per mark.

6.1.26.2 Instrument Card, cleaning status label should be proper.

6.3 Audit Trial Check as per below Check List:

Prepared By Reviewed By Approved By Authorized By

Prepared By Reviewed By Approved By Authorized By

 Controlled Copy 01 Quality Assurance

Prepared By Reviewed By Approved By Authorized By

FORMAT NO.: QAH-062/F01-02 Page X of Y

Prepared By Reviewed By Approved By Authorized By

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