GENTRY PHARMACEUTICALS LTD.

Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Receipt of Raw and Packing Material
SOP No.: SOP/WH/002 Revision No. 01 Superseded No.: 01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 Mohammed Belal Uddin

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

CONTENT
1. Objective
2. Scope
3. Responsibility
4. Accountability
5. Procedure
6. Precaution
7. Abbreviations
8. Distribution List
9. Revision History

1.0 Objective

To lay down the procedure for receiving of Raw and Packing Material.

2.0 Scope

This SOP is applicable of all Raw and Packing material received for stores Department at Gentry
Pharmaceuticals Ltd.

3.0 Responsibility

Store Executive/Officer

4.0 Accountability

Head of Department

WITHOUT PERMISSION FROM HEAD OF QUALITY ASSURANCE OR HIS/HER

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 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Receipt of Raw and Packing Material
SOP No.: SOP/WH/002 Revision No. 01 Superseded No.: 01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 Mohammed Belal Uddin

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

5.0 Procedure

Security personnel will receive and make entries in ‘Security Register for incoming RM/PM’ and will stamp at
the back side of the Invoice / Delivery Chalan with serial number, date and signature.

The security personnel will inform the concerned warehouse personnel regarding the receipt of material.
Warehouse personnel will verify the following against the purchase order and delivery Chelan / invoice.

 Name of material
 Quantity of material
 Delivery Location

The material will be unloaded from the vehicle under supervision of warehouse personnel to material receipt
area
The Warehouse personnel shall perform checking for received material in terms of physical appearance as
per SOP
The received materials shall be stored on pallets.

5.1 The receipt of each Raw and Packing Material is intimated by security.
5.2 Before unloading inspect the vehicle for cleanliness.

5.4
Each delivery of Raw and Packing Material should be examined visually while unloading, such as:
 Proper labeling of each container, and also check the intactness of the container.
 Match information on outer shippers or packs as mentioned in Delivery Challan.
 If Material received in Damage / Breakage / Leakage or not in intact conditions, such container is to be
segregated from other material and kept aside in a suitable manner.
 Record the discrepancy in material discrepancy note and inform to Head of QA & QC and take necessary
action as instructed by Head of QA & QC.

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 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Receipt of Raw and Packing Material
SOP No.: SOP/WH/002 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 Mohammed Belal Uddin

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

5.3 Each container, bags and packet should be cleaned from outside by vacuum cleaner/dry lint-free cloth in
receiving bay.

5.4 At the time of unloading Raw/Packing material it should be crossed verified with Invoice / Delivery
challan and must checked physically for the following points for its correctness and approved vendor List.
 Name of Material.
 Certificate of Analysis (COA)
 Purchase Order
 Packing List
 Batch No.
 Mfg. Date/Expiry Date, /Use before date
 Quantity per packet/Container
 Net. Weight, Gross Weight, Tare Weight.
 Description of the material grade/ pharmacopeia status, quantity in purchase order tallies with that
mentioned in delivery document.
 Storage condition on pack (container/Poly bag/box etc). If the avobe document is not received with the
consignment, immediately inform to purchase dept.

5.5 After de-dusting store person shall shift the material in the staging area for physical verification.

5.6 Physical verification for actual quantity is carried out for all RM & PM.

5.7 For packaging materials, random verification will be performed for checking the correctness of quantity
mention on the label by the party which will be mention in physical verification record.

5.8 Deface the approved label of the manufacturer on the container, with a black marker pen.

5.9 Transfer material to the quarantine area. If storage condition of the material is below 25°C transfer it to
RM Store.

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 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Receipt of Raw and Packing Material
SOP No.: SOP/WH/002 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 Mohammed Belal Uddin

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

5.10 Give the acknowledgement to the transporter; Record all the details in Material Inward Register
(RM/PM).

5.11 Prepare GRN and send to Quality Control Department for request Materials Analysis.

5.12 Raw Material GRN to be made batch wise and for Packing Material GRN is to be made Challan wise &
Product wise.

5.13 Affix “QUARANTINE” Label on each & every container for all Raw Material & Ensure that manufacturer
label or the name of the product should not be covered by the quarantine label.

5.14 Affix quarantine labels 100% on Printed Aluminum Foils.

5.19 For all other packing material affix 25% quarantine label of the total received packs. If more than 100
packs are received, affix 25 nos. quarantine label to the consignment. Remaining containers will be
identified with batch no.

5.15 Sampling of Raw Material and Packing Material will be done by Q.C.

5.16 After sampling, Q.C. Dept shall put sticker as “SAMPLED” adjacent on quarantine labels of sampled
containers.
5.17 After completion of analysis. Q.C person will affix the “APPROVED” or “REJECTED” label on the
“QUARANTINE” label.

5.18 Transfer the material to respective stores after QC analysis:

• If material approved by Q.C. department, Transfer the material to the designated approved storage area.
• If material rejected by Q.C. department, Transfer the material to the rejected room under lock and key.

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 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Receipt of Raw and Packing Material
SOP No.: SOP/WH/002 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 Mohammed Belal Uddin

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

5.19 All Raw Materials should be stored on pallets or racks in an orderly fashion to permit batch segregation
and First in First out stock rotation.

5.20 All “Approved” packing material product labels shall be stored in their respective lockers under lock &
Key. Ensure that one locker has only
one type of label.

5.21 In case of more than one lot /A. R. No., pack the labels in separate poly bags and arrange FIFO wise in
the respective locker.

5.22 Store the “Approved” aluminum foil in the foil storage room under controlled temperature.

5.23 In case of the raw material having specific storage condition, Quarantine & Approved Materials are
kept segregated in a specified area.

6.0 Precautions

1) Store all goods on pallets item wise and batch wise.

2) Keep some distance between wall & material so as to cleaning can be done easily.

7.0 Abbreviations

7.1 SOP – Standard operating procedure

7.2 QA – Quality assurance
7.3 QC – Quality control

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 GENTRY PHARMACEUTICALS LTD.
Vangnahati, Sreepur, Gazipur.

QUALITY ASSURANCE DEPARTMENT

STANDARD OPERATING PROCEDURE
Document Title SOP for Receipt of Raw and Packing Material
SOP No.: SOP/WH/002 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 Mohammed Belal Uddin

Designation Sr. QA Officer Quality Control Manager Quality Assurance Manager

8.0 DISTRIBUTION LIST

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

Quality Assurance Master & Control Copy 02

Quality Control Control Copy 01

Warehouse Control Copy 01

9.0 Revision History

SOP No Version No Date Reason of Revision

To set the details guideline and new initiated for Receipt of

SOP/WH/002 01 01.01.2019
Raw and Packing Material.

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