GOOD WAREHOUSING PRACTICES
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CONTENTS:
1. Introduction
2. Purpose
3. Various areas of ware housing
4. Design
5. General guidelines
6. Good warehousing practice
7. Rules for warehousing
8. Characters of good warehouse
9. Warehouse staff
10. Storage of material/products
11. Stock management
12. Quality assurance (sops)
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Introduction:
Maintaining proper storage condition for pharmaceutical
products and paramedical is vital to ensure their quality,
safety and efficacy.
Factory stores will invariably be receiving duly approved raw
materials and packaging materials from third party.
A suitable space is provided to raw material , handling of raw
& packaging materials required for manufacturing, including
packaging of pharmaceuticals. This space is known as
Warehouse.
It is a part of pharmaceutical company.
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For what purpose ?:
To enable the fastest and cheapest transport of drugs and
medical equipment from suppliers to beneficiaries.
There are mainly 3 stages:
1. Purchase of pharmaceutical
products.
3. Storage
2. of ordered
Distribution products.
of stocked products.
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VARIOUS AREAS OF WARE HOUSING :-
RECEVING AREA:- includes initial inspection, cleaning &
weight checking.
SAMPLING AREA:- with adequate facilities to prevent cross
contamination.
STORAGE AREA:- including specific storage like air
condition rooms, cold rooms, hazardous chemical storage
room.
REJECTED MATERIALS:-Destroye or retented unsuitable.
DISPENSING AREA:-with adequate facilities to preclude
cross contamination during dispensing.
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Design:
Prinoiple : Premises
must be located, designed,
constructed, adapted,
and maintained to suit the
operations to be carried out.
DIAGRAM FOR THE LAMOUT OF THE PHARMACEUTICAL WAREHOUSE
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Pharmaceutical warehouse
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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, build-up of dust or dirt, and, in general, any
adverse effect on the quality of products..
Where dust is generated (e.g. during sampling, weighing, mixing and
processing operations, packaging of powder), measures should be taken to
avoid cross-contamination and facilitate cleaning.
Premises should be situated in an environment in which the minimum
risk of any contamination of materials or products.
Premises used for the manufacture of finished products should be
suitably designed and constructed to facilitate good sanitation.
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Premises should be carefully maintained, and it should be ensured that
repair and maintenance operations do not causes any hazard to the quality
of products.
Premises should be cleaned and, where applicable, disinfected according to
detailed written procedures. Records should be maintained.
Electrical supply, lighting, temperature, humidity and ventilation should be
appropriate and such that they do not adversely affect, directly or indirectly,
either the pharmaceutical products during their manufacture and storage, or
the accurate functioning of equipment.
Premises should be designed and equipped so as to afford maximum
protection against the entry of insects, birds or other animals. There should
be a standard procedure to prevent from and pest control.
rodent
Premises should be designed to ensure the logical flow of materials and
personnel. 9
Q C O ffi c e s C a n te e
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C o r r id o r
U tilit ie s a n d S e r v ic e s W a s te Tr e a tm e n t
Zone: Clean Zone: Packaging Zone: Controlled
Arrival of goods, Entrance for visitors, Entrance for forkers,
shipment of goods
Example of material and people flow
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GENERAL GUIDE LINES :-
Materials received against specific supply devices
Each such consignment have written documents (delivery
Chelan)
All materials received by responsible persons
materials to be checked for cleanliness & package integrity
Damaged container separated & reporting immediately
Check for proper container labeling
i.e status of materials -UNDER TEST,
-A Waiting for APPROVAL .
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GOOD WAREHOUSING PRACTICE :-
Factory Stock which should be received with proper documents
detailing the names of product ,the batch number ,the number of
units of final packs of each batch ,the date of dispatch and the
quality control status of the batches.
The stock control system must be such that only passed batches of
products are issued for distribution. Stocks should be stored, product
wise to enable quick identification and control of stock movement
.Stocks should therefore be racked and stored in a manner that earlier
stocks are more early accessible than the later ones.
The picking and assembling areas should be so arranged as to
minimize the distance travelled by warehouse operators. Picking
stocks should be located on shelves at convenient heights and with
proper labels which clearly identify the products.
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Assembled products should be checked for accuracy of
quantities and identities of products ordered. Batch details
should be recorded in relevant documents.
Finished product should be packed in the containers and
dispatched for the transportation.
The unit product packs should be not contaminated by other
products. Vehicles which carry the final packaged stocks of
products should be so selected that-
1) They are clear, dry and sufficiently protected from rain
and other weather factors .
2) They are free from infestation .
3) They do not give off strong odours which may contaminate
the products .
4) They are suitable to withstand the weight of the load they
carry .
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RULES FOR WAREHOUSING :-
Systematic storage of the delivered goods.
Use air circulation & protection against
rodents
Keeping. a space at least 50cm between the rows of pellets
walls .
Providing each products have only one specific place.
On shelves clear labeling of products should be there .
Adequate space should be provided for each goods .
Provide separate stoke card for each products.
All boxes in stock should be closed .
Flammable products should stored in separate
place.
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CHARACTERS OF GOOD WAREHOUSE :-
Properly cleaned.
Good preservation of drugs & equipments.
Provide safety for staff & stocked goods.
Control of air, light ,humidity & temperature.
Products to be purchased according to needs.
Order the destruction of unsuitable products.
Promote rational use of pharmaceutical products.
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The warehouse staff:-
1.The responsible pharmacist
His duties
Good management of the stock of the
warehouse.
Good preservation of drugs and equipments.
Safety of stored goods.
2. The warehouse keeper
His duties
Reception of supplies.
Storage of stocks of goods.
Recording of every IN and OUT movement of the products in
the stock card.
Issue of products during manufacturing.
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3. The warehouse worker
His duties
Handling operations includes the carrying and moving of
goods which are intended for storage, shipment and sale.
The warehouse staff helps in receives and issue goods and
maintain inventory.
4. The cleaner
His duty
Ensure
cleanliness
5.The security guard
of premises
andHis duty
He is responsible for ensuring supervision and security of
equipment.
the warehouse .
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STORAGE OF RAW & PACKAGING MATERIALS :-
Storage condition- special storage area with controlled temperature , humidity &
stored off from the floor.
10. a) STORAGE OF PACKAGING MATERIAL :-
bottles, vials, ampoules, tins, tubes should be stored in a manner that they do
not contaminated by extraneous matter .
printed packaging material also stored properly .
Printed materials such as labels , printed films / foils /laminates, cartons should
kept in storage cupboards.
preventing mix up of printed & non printed materials .
Physical segregation of printed & labeled containers should be made .
Special precautions is needed for the storage of - packaging labeling controlled
products.
Appropriate storage condition to be provided ( air conditioning, aluminum foil)
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HANDLING & ISSUE – RAW MATERIALS :-
Attention to be made for -prevent cross contamination ,health
of personnel handling materials ,containers should be closed
properly ,materials that support microbial growth are handled
carefully. Eg.agar.
materials issued only against authorized person .
Personnel protective devices like gloves, facemasks etc.
should be used to avoid health hazards. Adequate dust
extraction system should be provided to suck away fine dust as
to prevent cross-contamination.
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HANDLING & ISSUE: PACKAGING MATERIALS :-
Packaging materials issued to production only against
packaging materials order.
Care should made to check for only right packaging materials
to be issued.
Unlike raw materials , exact quantity of packaging materials
to be issued.
Unused packaging materials returned to the warehouse & will
accompanied by authorized documents .
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WARE HOUSING OF FINISHED PRODUCTS :-
For avoiding deterioration, spoillage or breakage
requirements:-
safe , orderly & dispatch of all products -cold storage area
have temperature monitoring & recording devices -racking &
shelving system should have good mechanical strength .
Prooedure:-stock received from factory with proper
documentation (name, batch number, date of dispatch)
Finished products which are -under test" must be
quarantined
& segregated from -passed stocks”
Stock should be stored product wise to enable quick
identification & controlled stock movement
Store rotation should be on -first in ,first out basis.
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QUARANTINE
MATERIALS
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WARE HOUSING OF GOODS :-
RETURNED
Stocks should be carry out only consultation with quality
controlled manager.
Returned goods must be isolated on receipt ,clearly
identified
& records regarding reason for the return .
Qc manager should examine whether these goods are
reprocessed
Reprocessingorofdestroyed.
returned should be done according the
instruction of Qc manager.
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SANITATION:-
Written sanitation programmes should be available. These
should include validated cleaning procedures for premises
and equipment, a quality standard for water, instructions for
hygiene when manufacturing and handling goods, and
instructions relating to the health, hygienic practices, and
clothing of personnel and the disposal procedures for waste
materials and unusable residues.
Eating, smoking, and unhygienic practices should not be
permitted in manufacturing areas.
There shall be written procedures for use of suitable
rodenticides, insecticides, fungicides, fumigating agents and
cleaning and sanitizing agents.
cleaning procedure to be followed, including equipment and
materials . 24
MAINTANANCE :-
Any building used in the manufacture, processing, packing, or
holding of a drug product shall be maintained in a good state of
repair.
Deterioration of buildings not only presents a poor image of the
facility, it can also impact on product quality.
Cracks and holes in walls, floors, or ceilings can provide access
for insects, rodents, birds, dirt, or microorganisms.
They can also hinder cleaning and sanitation, thereby
increasing the potential for cross contamination or microbial
multiplication.
Floor cracks can also become a safety hazard for people or
even dislodge materials from trucks.
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The ingress of water from roof leaks can cause significant
damage to materials and equipment, give rise to electrical
failures and fires and result in damage to the basic structure
of the building.
Additionally, holes in the roof or near tops of buildings
theprovide ready access to birds, which may then be encouraged
to nest within the building.
STOCK MANAGEMENT:-
Objectives :-
To ensure continuity of supplies.
To avoid over stocking.
Stock management will set out to;
monitor stock levels
monitor consumption
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.
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Quality Assurance (SOPs) :-
Each warehouses will have to establish operating
procedures.
They must be clearly defined for each stage activities.
Direct purchase from raw materials manufactures.
Purchase via Head quarters.
Reception of local and imported orders.
Unpacking, labeling and storage of products.
Computerized stock managements.
Preparations of an orders for delivery.
Returns of drugs.
Managements of Expired drugs.
Safety and cleanliness of premises.
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Thank You
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