Logo Document No: xxx

ORGANIZATION NAME Approved date:

Effective date:
Title: Standard Operating Procedure for Pharmaceutical Storage Revision No. 00 Page 1 of 7
Practice

Title: Standard Operating Procedure for Pharmaceutical Storage Practice Logo

Status: SOP No.

Prepared by Approved by Revised by Version No.

Name: Name Name Effective date:

Sig: Sig: Sig: Review date:

Date: Date: Date: Supersedes:

Table of Contents

1. Purpose ................................................................................................................................2
2. Scope...................................................................................................................................2
3. Responsibilities....................................................................................................................2
3.1. Warehouse manager ..........................................................................................................2
3.2. Technical Director ............................................................................................................2
4. Definitions ...........................................................................................................................2
5. Materials and Equipment’s ..................................................................................................3
6. Procedures ...........................................................................................................................3
6.1. Warehouse manager ..........................................................................................................3
6.2. Technical manager ............................................................................................................4
7. Distribution .........................................................................................................................5
8. Records ...............................................................................................................................5
9. Revision History ..................................................................................................................5
Reference ................................................................................................................................5
Annexes ..................................................................................................................................6
Annex 1: Defined storage Instructions and Meanings ...............................................................6
Annex 2: Rejected products log ...............................................................................................6
Annex 3: Cleaning log sheet ...................................................................................................7

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Pharmaceutical Storage Revision No. 00 Page 2 of 7
Practice

1. Purpose
The purpose of this SOP is to describe the storage requirements of medicines and medical
products at warehouse and during transportation in the distribution channel.

2. Scope
This SOP is applicable to institutions involved in storage and distribution of stores
pharmaceutical products. These include but not limited to manufacturers, importers, distributors
and medicine retail outlets.

3. Responsibilities

3.1. Warehouse manager

 Receive and store medicines according to their storage conditions
 Daily Monitoring of temperature and relative humidity of the store
 Store products at their appropriate place.

3.2. Technical Director

 Ensure that medicines are stored according to their storage condition
 Document periodic monitoring record
 Ensure that this SOP is followed
 Update this SOP when required

4. Definitions
The definitions given below should be used in the context of this SOP only.
4.1. Expiry date: The date given on the individual container (usually on the label) of a
pharmaceutical product up to and including the date on which the product is expected to
remain within specifications, if stored correctly. It is established for each batch by
adding the shelf-life to the date of manufacture.
4.2. Packaging material: Any material, including printed material, employed in the
packaging of a pharmaceutical product, but excluding any outer packaging used for

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ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Pharmaceutical Storage Revision No. 00 Page 3 of 7
Practice

transportation or shipment. Packaging materials are referred to as primary or secondary

according to whether or not they are intended to be in direct contact with the product.
4.3. Pharmaceutical product: Any product intended for human use, presented in its finished
dosage form, which is subject to control by pharmaceutical legislation in either the
exporting or the importing state and includes products for which a prescription is
required, products that may be sold to patients without a prescription, biologicals and
vaccines.
4.4. Storage: The storing of pharmaceutical products and materials up to their point of use.
4.5. Supplier: A person or entity providing pharmaceutical products and materials upon
request. Suppliers may be agents, brokers, distributors, manufacturers or traders. Where
applicable, suppliers should be authorized by a competent authority.

5. Materials and Equipment’s

 Calibrated Digital thermo-hygrometers
 Logbooks
 protective or working garments
 Temperature and humidity recording log sheet

6. Procedures

6.1. Warehouse manager

 Receive pharmaceutical shipments in clean receiving bay as per receiving SOP (SOP
No…..) and check label such as Name, strength, batch number, expiry date according to
supplier dispatch document ( packing list, sales invoice etc).
 Store products on clean, undamaged pallets and according to product specification.
 Maintain adequate space between the rows of stored products for cleaning, monitoring
and inspection.
 Ensure safe and appropriate storage of pharmaceutical products.
 Properly handle and store NPS drugs in compliance with international conventions, and
national laws and regulations.

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Pharmaceutical Storage Revision No. 00 Page 4 of 7
Practice

 Store separately highly toxic and radioactive materials, and other hazardous, sensitive
and/or dangerous materials and pharmaceutical products in dedicated area that is subject
to appropriate additional safety and security measures.
 Follow appropriate stock rotation to ensure that the oldest stock sold first within its shelf
life and moved to the front of the picking face and the new stock put to the back.
 Store recalled and return products according in a dedicated area under key and lock and
clearly labelled.
 Periodically segregate and records damaged and expired products.
 Ensure cleanliness of warehouse, monitor as per cleaning schedule and records are
maintained as per Annex 3.
 Control and monitor room temperature and relative humidity using calibrated thermo-
hygrometer and records are maintained as per the temperature and RH log sheet.
 Check the condition of newly arrived cold box that contain the product.
 Ensure safe and appropriate storage of cold chain pharmaceutical products.
 check and ensure cold chain products are not placed directly against the refrigerator side
or back wall or near the cooling plate.
 Maintained sufficient space around the cold chain products for air to circulate.
 Check the expiry date of the cold-chain products on a regular basis.

6.2. Technical manager

 Ensure medicines are stored according to their storage condition.
 Ensure daily monitoring of temperature and relative humidity is carried out.
 Ensure handling of NPS according to national legislation.
 Ensure proper handling of recall, returned, expired products.
 keep all monitoring records for at least the shelf-life of the stored pharmaceutical
products pluses one year.
 Ensure cold-chain medicines are stored and managed properly.
 Ensure this SOP is followed and updated when required.

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Title: Standard Operating Procedure for Pharmaceutical Storage Revision No. 00 Page 5 of 7
Practice

 Monitor proper transfer of the products to the cold room.

7. Distribution

This SOP distributed to:

 Quality assurance department/general managing/ technical manager offices
 Warehouse manger

8. Records
8.1.After the completion of each activity, all documents and correspondence should be
recorded and filed in folder.
8.2.File numbers should be kept electronically and/or in hard copy for easy of tracing folders.
8.3.The change histories of this SOP should be kept and filed properly including all versions
8.4.The different versions should be kept for _____years in traceable manner.

9. Revision History

Revision number Summary of change Effective date

R0 New SOP To be assigned
R1
R2
R3

Reference
1. http://www.fmhaca.gov.et/documents/GDP,%20GSP%20and%20Recale%20Guideline%202
015.pdf
2. WHO, guide to good storage practices for pharmaceuticals, series No 908.2003.

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ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Pharmaceutical Storage Revision No. 00 Page 6 of 7
Practice

Annexes

Annex 1: Defined storage Instructions and Meanings

Storage condition on the label Interpretation

Freeze/Freezer The temperature is -20°C to -10°C
Refrigerator The temperature is 2°C to 8°C
Cold place The temperature is ≤ 8°C
Cool place The temperature is 8°C to 15°C
Room temperature The temperature is 15°C to 30°C
Do not store over 30°C From +2°C to +30°C
Do not store over 25°C From +2°C to +25°C
Do not store over 15°C From +2°C to +15°C
Do not store over 8°C From +2°C to +8°C
Do not store below 8°C From +8°C to +25°C
Protect from moisture ≤ 60% relative humidity
“Protect from light” To be provided to the patient in a light-resistant container
Do not store over 30°C From +2°C to +30°C
Do not store over 25°C From +2°C to +25°C
Do not store over 15°C From +2°C to +15°C

Annex 2: Rejected products log

Rejected Product Product Batch Quantity Reason Removed Disposition

by and name strength no. by and by RP
date date (R / D)*

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Logo Document No: xxx
ORGANIZATION NAME Approved date:
Effective date:
Title: Standard Operating Procedure for Pharmaceutical Storage Revision No. 00 Page 7 of 7
Practice

R (Returned to supplier), D (Destroyed)

Annex 3: Cleaning log sheet

Type of cleaning: Daily Monthly Annual

Date Cleaning carried Area cleaned Cleaning agent used Performed by Checked by
out

Reviewed by:___________________________Date:________________________