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Sop For Coa

This document outlines the standard operating procedure for issuing Certificates of Analysis (CoA) and Certificates of Compliance (CoC) for products dispatched from Triveni Polymers' pharmaceutical zones. It describes the responsibilities of quality control executives and managers in generating and approving CoA/CoCs based on dispatch plans and test results. The procedure specifies generating batch-wise CoA/CoCs, cross-checking information, and distributing office and customer copies. Revisions to CoA formats over time to meet regulatory requirements are also noted.

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SHUBHAM SAINI
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751 views

Sop For Coa

This document outlines the standard operating procedure for issuing Certificates of Analysis (CoA) and Certificates of Compliance (CoC) for products dispatched from Triveni Polymers' pharmaceutical zones. It describes the responsibilities of quality control executives and managers in generating and approving CoA/CoCs based on dispatch plans and test results. The procedure specifies generating batch-wise CoA/CoCs, cross-checking information, and distributing office and customer copies. Revisions to CoA formats over time to meet regulatory requirements are also noted.

Uploaded by

SHUBHAM SAINI
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Triveni Polymers Private Limited, Kundli (Haryana)

Department: Quality Control

Title: SOP for Issuance of CoA and CoC SOP #: SOP/WZ/QC/24:09

Prepared by Reviewed by Approved by Effective Date:

Signature Next Review Date:

S.D. Gupta Rajeev Kalra Supersedes:


Name Sudhanshu Yadav
SOP/WZ/QC/24:08
Designation Manager-QC Manager-QC GM-QA/QC Revision #:09
Date Revision Date: 23/11/20

1. Objective: To establish a system for the issuance of Certificate of Analysis and Certificate of
Compliance.

2. Scope: All the Dispatches made from Pharma Zones (WZ-I, WZ-IE & WZ-II).

3. Responsibility: QC-Executive & Incharge-QC.

4. Safety Precautions:
 CoA / CoC must be signed by the authorized person.
 Issue the CoA / CoC with every consignment dispatched to customer.
5. Procedure:
 QC will generate CoA/ CoC as per information provided in dispatch plan by Dispatch
Executive.
 CoA or CoC will be issued to customer, depending on his requirement.
 Generate CoA/ CoC batch wise.
 Dimensional results mentioned in CoA shall be taken from the first dimensional
inspection report (DIR) of particular batch.
 Cross check information provided in CoA/CoC before approval of the report.
 Two copies of CoA/ CoC will be generated –one for party and the other “OFFICE
COPY “for batch records.

Page 1 of 3
Triveni Polymers Private Limited, Kundli (Haryana)

Department: Quality Control

Title: SOP for Issuance of CoA and CoC SOP #: SOP/WZ/QC/24:09

Prepared by Reviewed by Approved by Effective Date:

Signature Next Review Date:

S.D. Gupta Rajeev Kalra Supersedes:


Name Sudhanshu Yadav
SOP/WZ/QC/24:08
Designation Manager-QC Manager-QC GM-QA/QC Revision #:09
Date Revision Date: 23/11/20

6. Documentation:
 Record of Certificate of Analysis issued
 Record of Certificate of Compliance issued

7. Change History:
Revision # Date Reason
01 01/11/06 Change in format and more details
02 16/01/07 Inclusion of Manufacturing Date in CoA/CoC format
03 01/01/10 Updating the procedure and inclusion of DB no in the remarks of CoA.
04 12/12/11 Inclusion of dispatches from White Zone-II
05 01/05/13 To change the identification ‘date of manufacturing’ to ‘month of
manufacturing’ in format of CoA and CoC.
06 01/05/16 Updating the format of CoA to include the new test requirement of USP39.
CC/QCD/16-17/01.
07 01/08/16 Updating the format of CoA to include the biological reactivity test and to
provide the separate format number for containers & caps CoA.
CC/QCD/16-17/01.
08 04/06/18 Inclusion of a process for consideration of dimensional inspection report
for CoA report preparation.

Page 2 of 3
Triveni Polymers Private Limited, Kundli (Haryana)

Department: Quality Control

Title: SOP for Issuance of CoA and CoC SOP #: SOP/WZ/QC/24:09

Prepared by Reviewed by Approved by Effective Date:

Signature Next Review Date:

S.D. Gupta Rajeev Kalra Supersedes:


Name Sudhanshu Yadav
SOP/WZ/QC/24:08
Designation Manager-QC Manager-QC GM-QA/QC Revision #:09
Date Revision Date: 23/11/20

CC/QAD/18-19/01
09 23/11/20 Update the COA format as per the current USP requirement by excluding
Biological Reactivity Test , In Vitro (87) and consideration of only IR test as
per USP chapter <661.1> and accordingly removal of Thermal Analysis
(DSC) test from COA.
CC/QAD/20-21/06

8. Distribution:
Copy # Copy Holders
Master Copy GM-QA/QC
Copy # 1 QC WZ-I
Copy # 2 QC WZ-II

9. Annexure(s):
Format 1: Format of Certificate of Compliance (F/WZ-QC/06)
Format 2: Format of Certificate of Analysis-Containers (F/WZ-QC/07)
Format 3: Format of Certificate of Analysis-Caps (F/WZ-QC/59)

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