Scribd
Upload
316 views25 pages

5.2 Warehousing

This document provides guidelines for pharmaceutical warehousing. It discusses definitions of warehousing and objectives of pharmaceutical warehouses. Key points covered include storage premises and conditions, shelf life management, stock management documentation, warehouse staff roles and responsibilities, and quality assurance procedures. The guidelines aim to ensure pharmaceutical products are stored and distributed safely and effectively.

Uploaded by

Indira
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
316 views25 pages

5.2 Warehousing

This document provides guidelines for pharmaceutical warehousing. It discusses definitions of warehousing and objectives of pharmaceutical warehouses. Key points covered include storage premises and conditions, shelf life management, stock management documentation, warehouse staff roles and responsibilities, and quality assurance procedures. The guidelines aim to ensure pharmaceutical products are stored and distributed safely and effectively.

Uploaded by

Indira
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 25

PHARMACEUTICAL

WAREHOUSING
CONTENTS
 Definition
 Objective
 A pharmaceutical warehouse for what ?
 Premises storage condition
 Shelf life of product
 General requirement for warehousing
 Stock management
 Documentation
 Reception of good
 Warehouse staff
 Quality assurance
 References
DEFINITION

 Warehousing refers to the activities involving storage of goods


on a large-scale in a systematic and orderly manner and making
them available conveniently when needed.
 Means holding or preserving goods in huge quantities from the
time of their purchase or production till their actual use or sale.
 Creates time utility by bridging the time gap between production
and consumption of goods
OBJECTIVE

 Factory stores will receiving the duly approved raw


materials and packaging material from third party.
 A suitable space is provided to raw material and
packaging material for each contract manufacturer. This
space is known as warehouse.
A pharmaceutical warehouse: for
what?

 To enable the fastest and cheapest transport of drug and


medical equipment from suppliers to beneficiaries.
 There are many three stages:
(1)Purchase of pharmaceutical product
(2)Storage of ordered products
(3)Distribution of stocked products
PREMISES

 PRINCIPLE: Premises must be located, designed, constructed ,adapted and maintained


to suit the operations to be carried out.
 General:-
 The layout and design of premises must aim to minimize the risk of errors and permit
effective cleaning and maintenance in order to avoid cross contamination.
 Where dust is generated e.g. – During sampling
 Weighing
 Mixing
 Processing operation
 Packaging of powder
So, measure should be taken to avoid cross contamination and facilitate cleaning.
 Premises should be situated in an environment to protect the manufacturing
process and minimum risk of causing any contamination of material or product.
 Premises should be suitably designed and constructed .
 Premises should be carefully maintained ,repair and maintenance operation do
not present any hazardous to the quality of product.
 Premises should be cleaned and where applicable disinfected according to detail
written procedure and record should be maintained.
 Electrical supply ,lighting ,temp., humidity an ventilation should be appropriate
and they do not adversely affect pharmaceutical product and storage.
 Premise should be designed to ensure the logical flow of material and personnel.
BASIC RULES FOR STORAGE

 Systematic storage of the goods.


 Use of pallets
 Provision of shelves
 Prevention of collapses
 Control product stored in a locking cabinet
 Flammable product stored in a separate well ventilated room .
WHO GUIDELINES FOR STORAGE
AREA

 Storage area should be of sufficient capacity.


 Storage condition
 Receiving area
 Receiving and dispatch by should be separated and protect material
and product from the weather.
 Segregation should be provided for the storage of rejected and
recalled or return material or product.
 Danger substance like radio active material , narcotic , and
dangerous drug presenting risk so should be stored in safe and secure
area.
 Printed materials
STORAGE OF MEDICINE BY
METHOD OF INGESTION

 Put the medicine in alphabetical order in each product family.


 Place in front of each medicine label ,give the generic name
(INN),dosage form and strength.
 Store the medicines with the nearest expiration date first (first
entry first out).
STORAGE CONDITION

TEMPERATURE
 Daily monitoring and recorded every hour.
 Temp in warehouse must exceed 25-30 C.
 Material that required stored cool place should be stored in air
condition rooms.
AIR
 All containers should be hermetically closed.
 Avoid prolonged unpackaged material .
 Prefer original packaging to guaranteed airtigthtness and opacity.
 Premises should not be ventiled.
LIGHT
 Many API should be stored in dark room.
API should not be directly exposed to sunlight and not to be issued
until and unless it is required in manufacturing.
SANITATION
 A written sanitation program be in place indicating the frequency
and method of cleaning the facility
 Storage area should be cleaned and accumulated waste removed at
regular intervals
 A pest control program should be in place
 Smoking ,eating and drinking should be permitted only in segregated
area, and not in those area use for the storage and handling of final
drug product
 Spills involving drug product must be promptly cleaned-up and
rendered safe in accordance with the relevant health and safety
requirements for the product
 Adequate toilet and changing facilities should be provided, and they
should be segregated from the main storage and order assembly area
Shelf life of the product

Expiry Date
 The expiration date applies to a drug in its original closed and undamaged package or
container .
 It must appear on the package and/or on the product.
 If this date is preceded by <USE BEFORE …>,
 then the first day of the started month shall be set.
Management of outdated products
 First, the expired products must be removed from the stock of the products. Stored in a
locked area.
 Secondly, these products are stored by form to be destroyed in compliance with law
and regulations.
ADDITIONAL GENERAL REQUIREMENT
FOR WAREHOUSING

 Clean the premises with disinfectants.


 To clean the ground surface regularly.
 To clean the undergrowth from around the warehouse regularly.
 Smoking and eating must be forbidden in the premises.
 Facilities of locking doors and protective windows.
 To provide extinguishers to fight fires.
 To fight against pests.
 Adapted and functional lighting as well as generator ready to works.
STOCK MANAGEMENT

OBJECTIVES
1. To ensure continuity of supplies
2. To avoid over stocking

Stock management will set out to;


3. Monitor stock levels
4. Monitor consumption
5. Anticipate delivery time for order activation.
ISSUING OF MATERIAL
 Store should issue raw and packaging materials on the basis of
FIFO (first come first out) basis. Entry and exit of every
consignment of materials should be entered on the stock card.
 Issuing of materials should do on the basis of raw and
packaging materials required in manufacturing process. While
issuing hazardous and explosive materials, the operation should
be supervised to prevent any mistake.
DOCUMENTATION

STOCK CARD
DEFINITION :- It is a simple and efficient tool that enables the
management of a warehouse. A stock card should be created for each
pharmaceutical product and regularly updated . They must be easily
accessible.
It is necessary to
 Identify stock movement : incoming and outgoing products
 Monitor the consumption of the different users.
 Monitor expiry dates
 Have data to plan subsequent orders.
Stock card characteristics
separate stock card should be maintained for each consignment
 exact description of the product
 expiry date of the product
 product movement ;date; incoming quantity and origin; outgoing quantities
;losses due to damaged product broken flask ,lost product
 Stock level after every movement.
Stock management
 with the help of computer for data processing
 product movement will be recorded and precaution should be taken.
INVENTORIES

Why do them
 It is essential to make an inventory of the quantities that really are
in stock.
 Inventory makes it possible to check the expiry date of all the
pharmaceutical products.
How to do them ?
 Inventory should made on regular basis .
 The inventory should be conducted in a minimum time.
RECEPTION OF GOODS

Inspection
 Collect and check all the document required for these
transport.
 Count the number of boxes on each pallet
 Check the condition of boxes :damaged, or opened .
 Check the special preservation condition
 Check the receive quantity
 Check the conformity of each product
THE WAREHOUSE STAFF

 The responsible pharmacist


 Warehouse keeper
 Warehouse worker
 The cleaner
 The security guard
QUALITY ASSURANCE

 Sops :- Each warehouse will have to establish operating procedure they must
be clearly defined for each stage activities
 Direct purchase from raw material manufacturers
 Purchase via head quarters
 Reception local and imported orders
 Unpacking ,labeling and storage of products
 Computerized management
 Preparation of an orders for delivery
 Repackaging
 Return of drugs
 Safety and cleanliness of premises.
REFFERENCES

 Good manufacturing practises for pharmaceutics,1st edition


,sidney H. willing,173-76.
 PSF-CL PHARMACEUTICAL GUIDE; how better to manage
pharmaceutical warehouse ,march 2003,3-21,27-31.
 Quality assurance of pharmaceutical ;GMP & inspection;vol-
ii.WHO publication ,Parma book syndicate ;28-32.
THANK
YOU

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy