The document provides an overview of pharmaceutical warehousing and material management, emphasizing the importance of good warehousing practices to maintain product quality. It outlines different types of warehouses, their characteristics, and guidelines as per WHO for storing pharmaceuticals. Additionally, it covers materials management principles and inventory control methods to ensure efficient operations and cost-effectiveness in pharmaceutical supply management.

1. UNIT II – CHAPT 4
Ms. TENY SARA THOMAS
MOUNT ZION COLLEGE OF
PHARMACEUTICAL SCIENCES
AND RESEARCH, ADOOR, KERALA
ASSISTANT PROFESSOR
B.PHARM SIXTH SEMESTER
PHARMACEUTICAL QUALITY
ASSURANCE
WAREHOUSING & MATERIAL MANAGEMENT

2. CONTENTS
Introduction
Types of Warehouses
Characters of Good Warehouse
Good Warehousing Practices
WHO guidelines of Good Warehousing Practices
Material Management

3. INTRODUCTION
• 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.

4. Various areas of warehousing :-
• Receiving area – include initial inspection, cleaning and
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 area
• Dispensing area
Premises must be located, designed, constructed, adapted
and maintained to suit the operations to be carried out.

5. TYPES
OF
WAREH
OUSE
PRIVATE
PUBLIC
CO-
OPERATIVE
BONDED
DISTRIBUTION
CENTRES
COLD
STORAGE
EXPORT/IMPORT
CLIMATE
CONTROLLED

6. • 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.

7. CHARACTERS OF GOOD WAREHOUSE
• 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.

8. 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.

9. 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

10. 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.

11. PREMISES AND FACILITIES
• 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
validated.

12. • 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
accurate performance of all operations.

13. STORAGE REQUIREMENTS
• 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.

14. • 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.

15. RETURNED GOODS
• Returned goods, must be handled according to approved
procedures
• 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.
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

16. 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.
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.

17. MATERIAL MANAGEMENT

18. 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
• To have adequate materials on hand when needed.
• To pay the lowest possible prices, consistent with quality
and value requirement for purchase materials
• To minimize the inventory investment
• To operate efficiently.

19. BASIC PRINCIPLES OF MATERIAL MANAGEMENT
• Planning
• Organizing
• Staffing
• Directing
• Controlling
• Reporting
• Budgeting
• Sound and effective purchasing system and methods
• Must not increase any other costs
• Simple inventory control programme
ELEMENTS OF MATERIAL MANAGEMENT
• Demand estimation
• Identify the needed items
• Calculate from the trend in consumption during last two years
• Review with resource constraints

20. 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

21. TYPES OF INVENTORY MODELS
• Economic order quantity (EOQ)
• Always Better Control (ABC) Analysis
• VED Analysis
• FSN Analysis

22. 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

23. 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)

24. 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.

25. 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
• No issues in the time period – N item
• 10-45 issues in time period – S item
• Exceeding other limits of issue – F item