PHARMACEUTICAL WAREHOUSING QUALITY ASSURANCE BP706TT B.PHARMA SEMESTER 7 jsmasipharmacy.blogspot.com SYLLABUS Warehousing procedures,Premises,Storage Condition,Stock management,Documentation,Inventories,Reception of goods,Audit

1. PHARMACEUTICAL WAREHOUSING
QUALITY ASSURANCE
BP706TT
B.PHARMA SEMESTER 7
jsmasipharmacy.blogspot.com
CONTENT
1. Objective
2. Reason
3. Warehousing procedures
4. Premises
5. Storage Condition
6. Stock management
7. Documentation
8. Inventories
9. Reception of goods
10.Audit
2
1.OBJECTIVE
1. Factory stores will invariably be receiving duly approved raw materials and packaging
materials from third party.
2. A suitable spaceis provided to raw material and packaging materials for manufacturer. this
spaceis known as Warehouse.
3. It is a part of pharmaceutical company.
2.FOR WHAT?
To enable the fastest and cheapest transport of drugs and medical equipment from suppliers to
beneficiaries

2. There are mainly 3 stages:
1. Purchase of pharmaceutical goods.
2. Storage of ordered products .
3. Distribution of stocked products.
3.WAREHOUSING PROCEDURES
1. Quarantine of drug products beforerelease by the quality control unit
2. Storage of the drug productunder appropriate condition of temp.,humidity and light so that
the identity strength,quality and purity of drug products are not affected.
4…PREMISES
Principle : Premises must be located, designed, constructed, adapted, and maintained to suit
the operations to be carried out.
It includes:
Ancillary areas,
Storage areas
Weighing areas
Production areas
Quality controlareas
Sterile areas 6
Storage areas

3. BASIC RULES FOR STORAGE
Systematic storage of the delivered goods.
Use of pallets.
Provision of shelves.
On shelves each productshall have one
specific place.
Prevention of collapses.
Controlled products stored in a lockingcabinet.
Flammable products stored in a separate well ventilated room.
Remove infested,damaged,or outdated goods immediately.
Suspectproducts shall be physically separated from other products stock.
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WHO GUIDELINES FOR STORAGE AREA
Storage areas should be of sufficient capacity to allow orderly storage of the various
categories of materials and products with proper separation and segregation.
Receiving and dispatch bays should be separated and protect materials and products from
the weather.
Segregation should be provided for the storage of rejected, recalled, or returned materials or
products
Highly active and radioactive materials, narcotics, other dangerous drug and substances
presenting special risks of abuse, or explosion should be stored in safe and secure areas.
There should normally be a separate sampling area for starting materials
5…STORAGECONDITION
A. TEMPERATURE
Daily monitoring and recorded every hour.
Temp. in warehouse must not exceed 25-300 C.
Material that required stored in coolplace should be stored in air condition rooms.

4. B. AIR
All containers should be hermentically closed.
Avoid prolonged unpackage material.
Prefer original packaging to guaranteed airtigthtness and opacity.
Premises should be ventilated.
C. LIGHT
Many API should be stored in dark room.
API should not be directly exposed to sunlight and not to be issued untill and unless it is
required in manufacturing.
6…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 preceeded by <USE BEFORE…>, then the first day of the stated 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 sorted by form to be destroyed in compliance with law and
regulations.
7….ADDITIONALGENERALREQUIREMENTFOR WAREHOUSING
Clean the premises with disinfectants.
To clean the ground surface regularly.

5. To clear the undergrowth from around the warehouse regularly. Smoking and eating must be
forbidden in the
premises.
Faclility of locking doors and protective windows
To provide extingushers to fight fires.
To fight against pests.
Adapted and functional lighting as well as generators ready to works. 16
8…STOCKMANAGEMENT
Objectives
To ensure continuity of supplies
To avoid over stocking
Stockmanagement will set out to;
monitor stocklevels
monitor consumption
anticipate delivery time for order activation. 19
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 stockcard.
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.
9…DOCUMENTATION
Stockcard
 It is a simple and efficient tool that enables the management of a warehouse.
 A stockcard should be created for each pharmaceutical productand regularly updated.They
must be easily accessible

6. It is necessary to
1. Identify stockmovements : incoming and outgoing products
2. Know the theoretical stocklevel at any point in time
3. Monitor the consumption of the different users
4. Monitor expiry dates
5. Assess losses by comparing the theoretical and real stocks
6. Have data to plan subsequent orders. 22
STOCKCARD CHARACTERISTICS
Separate stockcard should be maintained for each consignment
 Exact description of the product
 Expiry date of the product
 Products movements:date;incoming quantities and origin ; outgoing quantities and
destination; losses due to damaged products, brokenflakes, outdated products, lost
products
 Stocklevel after every movement
10…INVENTORIES
 Inventory makes it possible to check the expiry dates of all the pharmaceutical
products.
 It is essential to make an inventory of the quantities that really are in stock(physical
stock)
 The inventory should be conducted in a minimum time and the results should
immediately be recorded to enable normal working to resume. 25
11…RECEPTIONOF GOODS
Inspection of an order
 A separate rack should be provided to store approved raw and packaging materials.
Materials that is awaiting for approval should be kept in “Quarantine area”.
 Quarantine materials should be labeled “Under Test” till it released by Quality control
division.
 After receiving approval,it should be taken into stock.
 First inspection

7.  Collect and check all the documents required for these transports
 Count the number of boxes on each pallet and check that it conforms to the number given
by the supplier on the packing list.
 Check the condition of boxes : do some of them look to have been endamaged,opened.
 Check the special preservation conditions:cold chain 28
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SECOND INSPECTION
 Secondly,the consignment must be checked in full by the medical team should be
 Check that the goods delivered do correspond to the invoice;
 Check that the quantities received match the quantities shown on the packing list.
 Check the conformity of each product:designation,quantity per packing
unit,packaging,labeling,expiry date and productappearance(color change,precipitation
etc)
12…THE WAREHOUSE STAFF
1. The responsible pharmacist
2. The warehouse keeper
3. The warehouse worker
4. The cleaner
5. The security guard
13… 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
 Computriazed stock managements
 Preprations of an orders for delivery
 Repacking or ordersf
 Returns of drugs

8.  Managemenets of outdated drugs
 Safety and clenlines of premises
14…AUDITS
Audits aim at assessing the activities and organization of the warehouse.
They aim at answering key questions such likes
Have initially set of activities & quality objectives been reached?
Are procedures correctly written respected,reviewed?
Does the warehouse guarantee for safety standards? 33
REFERENCES
1. Good manufacturing Practices For Pharmaceutics, 4st edi.,Sidney Willing,130- 131.
2. PSF-CIPHARMACEUTICAL GUIDE; How better to manage pharmaceutical warehouses,
March 2003,2-21,27-31.
3. Quality Assurance of Pharmaceuticals; GMP & Inspection;vol.-II.WHO Publication,Pharma
bookSyndicate;28-32.
4. SOP GUIDELINES,D.H. Shah, business Horizons, Pharmaceutical Publishers,2nd reprint
edition,2004,410 34