GENTRY PHARMACEUTICALS LTD.

Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Storage and Use of Reagents & Chemicals
SOP No.: Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Ratan Chandra Saha

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

CONTENT
1. Objective
2. Scope
3. Responsibility
4. Accountability
5. Procedure
6. Received of Reagents & Chemicals
7. Opening date of Reagents and Chemicals
8. Expiration of Reagents and Chemicals
9. Abbreviation
10. Revision History

1.0 Objective

To monitor storage and use of reagents & chemicals in quality control department.

2.0 Scope

This SOP is applicable to all chemical reagents and solutions used for analytical testing, such as acids,
bases, solvents, volumetric and indicator solutions. This SOP does not apply to reference standards, sample
solutions or chemicals for general use, such as cleaning agents for quality control Department at Gentry
Pharmaceuticals Ltd.

3.0 Responsibility

3.1 Doing: Technical Assistant

3.2 Checking: QA/QC Executive/Manager

4.0 Accountability

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER

DELEGATE, COPY OF THIS DOCUMENT IS STRICTLY PROHIBITED Page 1 of 4
 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Storage and Use of Reagents & Chemicals
SOP No.: Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Ratan Chandra Saha

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

Head of the Department

5.0 Procedure

5.1 Receipt of Reagents and Chemicals

After receiving the material QC personnel will check the detail information given on Container label and
enter the following details in the material control register maintain separately for Reagents, Solvent and
Indicator in Q.C. Department for ensure the material is received from the approved vendor by referring the
approved vendor list.

 Material Receiving Date

 Name of the Material
 Total Quantity
 Mfg. Date
 Exp. Date
 Material Code
Upon receipt, examine the container of any new reagent or chemical for damage. Damaged materials are to
be returned to the supplier or disposed of according to established procedures. Upon receiving a receiving
date is assigned on each label.
6.0 Opening date of Reagents and Chemicals

When a container is first opened, initial and records the date on the label.

7.0 Expiration of Reagents and Chemicals

Expiration date after opening is assigned and written on each label.

 Use the supplier label recommendation and initial and record the date on the label.

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER Page 2 of 4

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

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Storage and Use of Reagents & Chemicals
SOP No.: Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Ratan Chandra Saha

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

 If not indicated on the original supplier label an expiration date of not more than five years from
receipt is assigned to all reagents and chemicals when know to be very stable.
 Store the reagents & chemicals at appropriate temperature & condition indicated on the container.
 Mention shelf life of all reagents/chemicals for 2 years from the date of opening the container

 Store poisonous chemicals separately taking all safety precaution as per their Material Safety Data
Sheet. (M.S.D.S)
 Example: A chemically and physically stable reagent or chemical is received in May
2003 without an expiration date, then it is assigned an expiration date of May 2008.
 Destroy the reagents/chemicals after expiry date as per SOP.

8.0 Abbreviation

SOP= Standard Operating Procedure

EXP = Expiry
MSDS = Material Safety Data Sheet.

9.0 DISTRIBUTION LIST

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

Quality Assurance Master & Control Copy 02

Quality Control Control Copy 01

Production Control Copy 01

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

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Storage and Use of Reagents & Chemicals
SOP No.: Revision No. 01 Superseded No.: 01

Issue Date 01.01.2019 Effective Date: 10.01. 2019 Review Date: 01.01. 2022

Prepared by Checked by Approved by

Sign. & Date

Name Abdulla Al-Mamun Md. Kamrul Islam Ratan Chandra Saha

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

10. Revision History

SOP No Version No Date Reason of Revision

To set the details proper guideline and new initiated for

01 01.01.2019
Storage and Use of Reagents & Chemicals.

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