Transcript pharmaceutical warehouseing

PHARMACEUTICAL WAREHOUSING
PREPARED BY :- PARAS SHAH
GUIDED BY :- MR.DHAVAL RATHOD
M.PHARM SEM – 1 (Q.A.)
SMT.R.D. GARDI B.PHARMACY COLLEGE
CONTENT
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Objective
A pharmaceutical warehouse for what ?
Premises storage condition
Shelf life of product
General requiremet for warehousing
Stock management
Documantation
Reception of good
Warehouse staff
Quality assurance
Reference
1. OBJECTIVE
Factory stores will invariably be receiving duly
approved raw materials and packaging material
from third party.
 A suitable space is provided to rew material
and packaging material for each contrac
manufacturer. This space is known as
warehouse.
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2. A PHARMACEUTICAL WAREHOSE: 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
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3. 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.
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Where dust is generated
e.g. – During sampling
- weighing
Mixing
Processing operation
Packaging of powder
measure should be taken to avoid cross
contamination and facilitate cleaning.
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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 acceding 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.
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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 .
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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
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Danger substance like radio active material ,
narcotic , and dangerous drug presenting risk
so should be stored in safe and secure area.
 Printed materials
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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).
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4. STORAGE CONDITION
( A ) 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.
(B) AIR
 All containers should be hermetically closed.
 Avoid prolonged unpackaged material .
 Prefer
original packaging to guaranteed
airtigthtness and opacity.
 Premises should not be ventiled.
(C) 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
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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
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5. SHELF LIFE OF THE PRODUCT
A 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.
B 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.
6. 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.
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Facilities of locking doors and protective
windows.
 To provide extinguishers to fight fires.
 To fight against pastes.
 Adapted and functional lighting as well as
generator ready to works.
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7. STOCK MANAGEMENT
OBJECTIVES
1. To ensure continuity of supplies
2. To avoid over stocking
Stock management will set out to;
1. Monitor stock levels
2. Monitor consumption
3. 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.
8. DOCUMANTATION
STOCK CARD
DEFINATION :- 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
 Register of controlled products
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9. 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.
10. 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
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 Check the special preservation condition
 Check the receive quantity
 Check the conformity of each product
11. THE WAREHOUSE STAFF
The responsible pharmacist
 Warehouse keeper
 Warehouse worker
 The cleaner
 The security guard
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12. QUALITY ASSURANCE
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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.
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THANK YOU