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20.SOP-Code Structure For Indicator

This standard operating procedure outlines the code structure for laboratory indicators at Gentry Pharmaceuticals Ltd. The code structure assigns a unique three-digit code to each laboratory indicator using the format LIXXX, where LI stands for laboratory indicator and XXX is a sequential three-digit number. The quality assurance officer is responsible for assigning code numbers and maintaining a code list. The procedure aims to maintain the identity and traceability of laboratory indicators throughout the quality control process.

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Bejoy Karim
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387 views

20.SOP-Code Structure For Indicator

This standard operating procedure outlines the code structure for laboratory indicators at Gentry Pharmaceuticals Ltd. The code structure assigns a unique three-digit code to each laboratory indicator using the format LIXXX, where LI stands for laboratory indicator and XXX is a sequential three-digit number. The quality assurance officer is responsible for assigning code numbers and maintaining a code list. The procedure aims to maintain the identity and traceability of laboratory indicators throughout the quality control process.

Uploaded by

Bejoy Karim
Copyright
© © All Rights Reserved
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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GENTRY PHARMACEUTICALS LTD.

Vangnahati, Sreepur, Gazipur.

STANDARD OPERATING PROCEDURE


Document Title Code Structure for Laboratory Indicator
Document No.: SOP/02/003 Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 10.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

Contents:

1. Objective
2. Scope
3. Responsibilities
4. Procedure
5. Attachment
6. Distribution List
7. Revision History

1.0 Objective
To describe the code number assignment for Laboratory Indicators to maintain their identity and
traceability throughout the work process in Quality Control Department at Gentry Pharmaceuticals Ltd.
(GPL).

2.0 Scope
This SOP is applied to Code Structure for Laboratory Indicators and its supporting activities in Quality
Control Department at Gentry Pharmaceuticals Ltd. (GPL).

3. 0 Responsibilities
This is the responsibility of Quality Control Officer, Product Development Officer and Quality Assurance
Officer to follow the procedure.

Head of Quality Assurance or his/her designates is responsible for SOP compliance.

4. 0 Procedure
a. A code number is assigned for each Laboratory Indicator by Head of Quality Assurance or his/her
designate officer.

b. Laboratory Indicator Code Numbering system is LIXXX

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER


Page 1 of 3
DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED
GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

STANDARD OPERATING PROCEDURE


Document Title Code Structure for Laboratory Indicator
Document No.: SOP/02/003 Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 10.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

Where LI – Laboratory Indicator


XXX – Three digit Laboratory Indicator Sequential number supplied by relevant department
and starting with 001.

5. 0 Attachment

Attachment 01: Laboratory Indicator Code List [AL/006]


Attachment 02: Request Form for Issuing New Code Number [F/01/0001]
Attachment 03: SOP Training Record [F/07/0001

6.0 Distribution List:

Department Master/Control Copy No. of Copy Received By (Signature & Date)


Quality
Master & Control Copy 02
Assurance
Quality Control Control Copy 01

Warehouse Control Copy 01

7. 0 Revision History

SOP No. Version No. Date Reason of Revision

Newly initiated to serve as a guide in Coding Laboratory


SOP/02/003 01 01.01.2019
Indicator.

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER


Page 2 of 3
DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED
GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

STANDARD OPERATING PROCEDURE


Document Title Code Structure for Laboratory Indicator
Document No.: SOP/02/003 Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 10.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam

Designation Sr. Quality Assurance Officer Quality Control Manager Quality Assurance Manager

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER


Page 3 of 3
DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED

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