1. A Seminar On
Pharmaceutical Warehousing
Prepared By: Ravi Akhani
(M.Pharm (Q.A.), Semester-1)
Guided By: (1) Mr. Rajesh Parmar
2. Contents:
1. Objective
2. A pharmaceutical warehouse: for what?
3. Premises
4. Storage condition
5. Shelf life of the product
6. General requirement for warehousing
7. Stock management
8. Documentation
9. Inventories
10. Reception of goods
11. The warehouse staff
12. Quality assurance
13. Audits
3. 1. Objective:-
- Factory stores will invariably be receiving duly
approved raw materials and packaging materials
from third party.
- A suitable space is provided to raw material and
packaging materials for each contract
manufacturer.
This space is known as Warehouse.
4. 2. A pharmaceutical warehouse: for what?
- 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
(2) Storage of ordered products
(3) Distribution of stocked products
6. 3. Premises:-
- Principle: Premises must be locked, designed,
constructed, adapted, and maintained to suit the
operations to be carried out.
7. 4. Storage condition:-
A. Temperature
- Daily monitoring and recorded every house.
- Temp. in warehouse must not exceed 25-30oC.
B. Air
- All containers should be hermetically closed.
- Avoid prolonged unpack age material.
- 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 until and unless it is required in manufacturing.
11. 5. Shelf life of the product:-
A. Expiry Date
- It must appear on the package and/or on the product.
- The expiration date applies to a drug in its original closed
and undamaged package or container.
B. Management of outdated products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.
12. 6. 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.
- Facility of locking doors and protective windows.
- To provide extinguishers to fight fires.
- To fight against pests.
- Adapted and functional lighting as well as generators
ready to works.
13.
14. 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.
15. 8. Documentation:-
- Stock card
Definition:- 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
- Know the theoretical stock level at any point in time
- Monitor the consumption of the different users
- Monitor expiry dates
- Assess losses by comparing the theoretical and real
stocks
- Have data to plan subsequent orders.
16. 9. Inventories:-
Why do them
- It is essential to make an inventory of the quantities that really are in
stock.
- Mistakes, omission or thefts can explain the differences between the
theoretical and real stock. Those differences should of course be cleared
up.
- Inventory makes it possible to check the expiry dates of all the
pharmaceutical products.
How to do them?
- Inventories should be made on a regular basis with a frequency defined
by a procedure specific to each warehouse.
- On the day of the inventory, all activities should be stopped except the
counting of stocks: NO IN OR OUT MOVEMENT OF
PRODUCTES on that day.
- The inventory should be conducted in a minimum time and the results
should immediately be recorded to enable normal working to resume.
19. 10. Reception of goods:-
Inspection of an order
- A separate rack should be provided to store
approved raw and packaging materials. Materials
that are waiting for approval should be kept in
“Quarantine area”.
- After receiving approval, it should be taken into
stock. Quarantine materials should be labeled
“Under Test” till it released by Quality control
division.
20. 11. The warehouse staff:-
(1) The responsible pharmacist
(2) The warehouse keeper
(3) The warehouse worker
(4) The cleaner
(5) The security guard
21. 12. Quality Assurance:-
SOPs
Each warehouse 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 order for delivery
- Returns of drugs
- Managements of outdated drugs
- Safety and cleanliness of premises.
22. 13. Audits:-
Audits aim at assessing the activities and
organization of the warehouse. Their 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?
23. -:REFERENCES:-
1. Good manufacturing Practices For Pharmaceutics, 1st
edition, Sidney H. Willing, 173-175.
2. PSF-CI PHARMACEUTICAL GUIDE; How better to
manage pharmaceutical warehouses, March 2003, 2-21, 27-
31.
3. Quality Assurance of Pharmaceuticals; GMP & Inspection;
vol.-2. WHO Publication, Pharma book Syndicate; 28-32.
4. SOP GUIDELINES, D.H.Shah, business Horizons,
Pharmaceutical Publishers, 2nd reprint edition, 2004, 410.
