The document discusses good warehousing practices for pharmaceutical products. It outlines the WHO guidelines which include 6 key areas: 1) personnel requirements to properly staff and train warehouse employees, 2) premises and facility standards regarding storage areas, conditions and security, 3) storage requirements such as documentation, labeling and container standards, 4) handling returned goods with established procedures, 5) dispatch and transportation standards to maintain product quality during delivery, and 6) product recall protocols for defective goods. Following good warehousing practices helps ensure the quality of pharmaceutical products is maintained throughout the storage and distribution process.

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2.  Personnel
 Premises and Facilities
Storage Requirements
 Returned Goods
 Dispatch and Transportation of Goods
 Product Recall 2
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3. Introduction
 In the pharmaceutical industry, it is critical to pay
attention to the storage and distribution of products.
 Different dosage forms must be stored and transported
under different environmental conditions and therefore,
there cannot be one general rule for their handling.
 Thus, it is vital to follow good warehousing practices and
good distribution practices to ensure the quality of products
is maintained.
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4. • WAREHOUSE- A suitable space is provided to raw material,
handling of raw and packaging materials required for
manufacturing. This space is known as Warehouse.
 Different dosage forms must be stored and transported
under different environmental conditions and therefore,
there cannot be one general rule for their handling.
 Maintaining proper storage condition for pharmaceutical
products is vital to ensure their quality, safety and
efficacy.
 Thus, it is vital to follow Good Warehousing Practices
and Good Distribution Practices to ensure the quality of
products is maintained.
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5.  Various Areas Of Warehousing
1. ReceivingArea – include initial inspection, cleaning and
weight checking.
2. Sampling Area– with adequate facilities to prevent cross
contamination
3. Storage Area – including specific storage likeair condition
rooms, cold rooms, hazardous chemical storage room.
4. Rejected Materials Area- separate areas must be provided
for storing rejected products.
5. Dispensing Area - Premises must be located, designed,
constructed, adapted and maintained to suit the operations to
be carried out.
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6. TYPES OF
W
AREHOUSE
PRIVATE
PUBLIC
CO-
OPERA
TIVE
BONDED
DISTRIBUTION
CENTRES
COLD
STORAGE
EXPORT/IMPORT
CLIMATE
CONTROLLED
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7. Private warehouse :- operated by a company for shipping, and storing
its own products. Owned and managed by manufacturers or traders
Public warehouse:- provide storage and physical distribution services on
rental basis. These are used by small and large firms.
Co-operative warehouse :- owned, managed, and controlled by co-
operative societies.
Bonded warehouse :- licensed to accept imported goods for storage
before payment of customs duty
Distribution centres :- designed to move goods, highly automated.
Receive goods and efficiently deliver to customers.
Cold storage :- temperature is controlled here for sensitive products.
Export/ Import warehouse :-located near ports where international trade
is undertaken. These provide storage facilities for goods awaiting
onward movements.
Climate – controlled warehouse :- provide storage of many products
which need special handling conditions. Freezers for frozen products,
etc.
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8. CHARACTERS OF GOODWAREHOUSE
 Convenient location.
 Availability of mechanical appliances to load and unload
goods.
 Properly cleaned.
 Latest fire fighting equipments.
 Good preservation of drugs and equipments.
 Provide safety for staff and stocked goods.
 Control of air, light, humidity, and temperature.
 Products to be purchased according to needs.
 Order the destruction of unsuitable products.
 Promote rational use of pharmaceutical products.
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9. GOOD WAREHOUSING PRACTICES
Guidelines of Good Warehousing Practices include :-
 Drugs must be stored to prevent contamination, and be positioned to
allow for inspection and cleaning of the area
 Each lot of drug products must be identified with a distinctive code,
and the lots status must be identified – approved, quarantined, and
rejected.
 Written procedures must describe the distribution process for each
drug.
 Written procedures must describe the appropriate storage conditions
for each drug
 Warehouse must ensure that the storage of each drug is in line with its
specific requirements defined by the manufacturer.
 Temperature controlled space requires sophisticated control and
monitoring equipment to ensure that the temperature of the facility
stays within very specific parameters.
 Climate controlled space regulates and monitors both the temperature
and humidity of the space.
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10. The WHO guide to good storage practices for
pharmaceuticals highlights the following important
areas for warehousing of pharmaceuticals.
1) Personnel
2) Premises and Facilities
3) Storage Requirements
4) Returned Goods
5) Dispatch and Transportation of Goods
6) Product Recall
WHO GUIDELINES OF GWP
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11. 1) PERSONNEL
All sites where pharmaceutical products are stored must have
sufficient number of appropriately qualified and trained
personnel.
Warehouse staff should include – a responsible pharmacist,
warehouse keeper, warehouse worker, cleaner, security guard.
Staff must be given necessary training on good storage
practices, the best practices to adopt and safety issues.
They must also be trained on matters of personal hygiene,
good sanitation practices, use of working garments and
suitable protective clothing.
Those employees working in special storage areas must be
trained on the regulations, and procedures to be followed.
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12. 2) PREMISES AND FACILITIES
A) Storage Area:-
 Entry
 Size
 Storage Condition
 Cleanliness
 External Areas
 Quarantine Areas
 Sampling
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13.  Storage of rejected, expired, returned or recalled materials or
products
 Special materials storage
 Handling and distribution
 Rotation of stock
 Rejected materials
 Narcotic drugs storage
 Damaged items
 Lighting
B) Storage Conditions
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14. Entry must be controlled and only authorized persons must be
permitted to enter.
Area must be sufficient size to allow the systematic storage of
different categories of materials.
There must be separate areas for products in quarantine,
approved products, and products that have been rejected,
recalled etc.
Temperature and relative humidity should be maintained
according to the requirement. There must be provisions to
monitor such parameters.
All materials should be stored in manner which supports ease
of cleaning as well as inspection.
Measures should be taken to prevent accumulation of waste,
entry of vermin and pest. Agents used for cleaning should be
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15. Receiving and dispatch areas should be designed to protect
materials from weather conditions.
Separate sampling areas must be provided in a controlled
environment.
Products that are sensitive, dangerous, hazardous, narcotic etc
with a risk of fire, explosion, or abuse must be stored in dedicated
areas with sufficient security and safety measures.
Procedures must be designed to prevent mix-ups, contamination
and cross contamination.
Damaged items must be immediately removed from the usable
stock.
Storage of narcotic drugs must comply with international
conventions.
Rejected materials must be clearly marked and controlled.
All areas must be lighted appropriately to allow the safe and
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16. 3) STORAGE REQUIREMENTS
A) DOCUMENTATION
1. Instructions and records
2. Information of each product
3. Delivery records
4. Comprehensive records
B) LABELLING AND CONTAINERS
1. Storage containers
2. Containers labeling
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17. Written instructions as well as records must be available to
document all activities take place in the storage area.
The route taken by the products and information through the
organisation must be describe in sufficient details.
Each product stored must have permanent information
regarding the storage conditions and precautions to be
observed.
Records must be maintained for every delivery and include
the description of goods, quantity, quality, etc.
Products must be stored in appropriate containers so that their
quality is not affected.
Minimum labelling requirements for containers include, name
of the material with pharmacopoeial reference, batch number,
expiry date, date of re-test and storage conditions.
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18. Every incoming material should be checked immediately against
the order, then physically verified.
Uniformity of containers must also be verified. Every container
must be carefully checked for contamination, damaging, or
tampering.
Sampling should be done and then the goods should be taken to
quarantine area
Warning signs for – spillage, odours, dirt, tears, scratches, animal
faeces.
Actual stock must be compared with recorded quantity of stocks
Expired or outdated products must be periodically checked and
removed. Until such material, precautions must be taken to ensure
they are not issued for use.
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19. Returned goods, must
procedures.
be handled according to approved
Records of the returned goods should be maintained.
Goods that pass a quality re – evaluation, may be returned to stock
approved for sale.
Any pharmaceutical product returned by patients to the pharmacy
must be destroyed.
4) RETURNED GOODS
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20. 5) DISPATCH AND TRANSPORTATION OF GOODS
This should be done under conditions that ensure the prescribed
storage conditions are maintained, and integrity of the product is
not affected.
When transported, devices must be used to monitor temperature
conditions, records of such delivery must be maintained.
Records should be contained – dispatch date, customer name,
address, product description, quantity, storage conditions
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21. 6) PRODUCT RECALL
Appropriate procedures must be set in place for prompt and
effective recalls of known and suspective defective product.
Product recalls can be triggered by any of the following
situations :-
 Customer complaints that draw attention to a critical quality
defect.
 Reports of adverse drug reactions.
 Samples retained for stability studies show deterioration of
product quality.
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22. Once finished products, reach the warehouse, they are
not subjected to any further testing or inspection.
Good Warehousing Practices must be followed by
adequately trained personnel to make sure that the quality
of the product reaching the end user is the same as it was
when it left the manufacturing unit.
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24.  INTRODUCTION
Important management tool which will be useful in
getting the right quality and right quantity of supplies at
right time, having good inventory control and adopting
sound methods of condemnation and disposal will
improve the efficiency of the organisation.
FOUR BASIC NEEDS OF MATERIAL MANAGEMENT
1. To have adequate materials on hand when needed.
2. To pay the lowest possible prices, consistent with quality
and value requirement for purchase materials
3. To minimize the inventory investment
4. To operate efficiently.
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25. BASIC PRINCIPLES OF MATERIALMANAGEMENT
Planning
Organizing
Staffing
Directing
Controlling
Reporting
Budgeting
Sound and effective purchasing system and methods
Must not increase any other costs
Simple inventory control programme
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26. ELEMENTS OF MATERIALMANAGEMENT
Demand estimation
Identify the needed items
Calculate from the trend in consumption during last two years
Review with resource constraints
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27.  INVENTORY CONTROL
The term Inventory means the value or amount of
materials or resource in hand.
Inventory Control is the process by which inventory is
measured and regulated accordingly.
Ensures an adequate supply of materials
Better utilisation of available stocks
Checks against the loss of materials
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28. TYPES OF INVENTORY MODELS
1. Economic order quantity (EOQ)
2. Always Better Control (ABC)Analysis
3. VEDAnalysis
4. FSNAnalysis
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29.  ECONOMIC ORDER QUANTITY
EOQ is the technique of ordering materials whenever
stock reaches the reorder point.
In this technique, the order quantity is larger than a
single period’s requirement so that ordering costs and
holding costs balance out.
EOQ = (average monthly consumption * lead time) +
buffer stock – stock on hand
Lead time = duration time between placing an order and
receipt of material
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30.  ALWAYS BETTER CONTROL (ABC) ANALYSIS
This technique divides inventory into three categories
This technique is based on cost criteria
‘A’ items category – smaller in quantity but consume a
large amount of financial resources. Managed by the top
management and they should have a strict and closer
watch. ( 10% materials , 70% cost)
‘B’ items category – intermediate level. Managed by the
middle level management and should have moderate
safety stocks. (20% materials, 20% cost)
‘C’ items category – larger in quantity but consume a
smaller amount of the financial resources. Requires only
ordinary control measures (70% materials, 10% cost)
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31.  VED ANALYSIS
Based on critical value and shortage cost of an item
Items are classified into –
Vital – shortage of products cannot be tolerated. They are
stocked adequately to ensure smooth operation.
Essential – shortage can be tolerated for a short period.
They should be efficiently stocked to ensure regular flow
of work
Desirable – shortage will not adversely affect, but may
be using more resources. They can be easily purchased
from the market as and when needed.
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32.  FSN ANALYSIS
FSN :- Fast moving, Slow moving, and Non –
Moving
Classification is based on the pattern of issues from
stores and is useful in controlling obsolescence.
The items are usually grouped in periods of 12
months.
Helps to avoid investments in non moving or slow
items
Exceeding other limits of issue – F item
10-45 issues in time period – S item
No issues in the time period – N item
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33. REVIEW QUESTIONS
1. Discuss the requirements of good warehousing practices.
2. Explain the steps in receiving and storage of materials in the
warehouse.
3. Enumerate the precautions to be taken when handling goods in the
warehouse.
4. List and describe the records to be maintained in a pharmaceutical
warehouse.
5. Explain the stock rotation principle used in pharmaceutical
storage.
6. Discuss the segregation of materials in a warehouse.
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34. REFERENCES
1) A Text book of Pharmaceutical Quality Assurance by
the author Anusuya R.Kashi, Bindu Sukumaran, And
Veena P. Nirali Prakashan. Page No.15.1-15.6
2) www.slideshare.com
3) www.google.com
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