This document discusses the warehousing and storage of drugs. It outlines various factors that affect drug potency during storage such as temperature, humidity, light, and pest control. It describes appropriate storage conditions for different drug types and temperatures. The document also discusses stability testing of drug products and the causes of drug deterioration including physical, chemical, microbial changes. It covers expiry dates, shelf life, and recall procedures for unstable drug products.

1. WAREHOUSING OF DRUGS
Presented by;
AISWARYA.A.T
First year M.Pharm, Dept of Pharmacy Practice.

2.  Storage is the physical process of storing or
housing drug materials in a specified area.
 Schedule P
WAREHOUSING OF DRUGS

3. FACTORS AFFECTING THE POTENCY OF
DRUG DURING STORAGE
• Temperature
• Humidity (moisture content)
• Light
• Pest control
• Instability problems:
Aging of drug products
Packages
Expiry date
Shelf life

4. Storage conditions Temperature in oC
cold temperature 2 to 8
Cool temperature 8 to 25
Room temperature 25 to 30
Warm temperature 30 to 40
Excessive heat Above 4o
Controlled room temperature 15 to 30
Freezer -20 to -10
Extreme heat Above 40
Dry place 40% average relative humidity
STORAGE CONDITIONS

5. STABILITY OF DRUG PRODUCTS
Significance:
•To provide right & standard quality of drug.
•To ensure uniform dose of drug throughout during the
shelf life.
•Legal & statuatory requirements related to quality,
identity, purity & strength.
•To prevent economic repercussions of marketing an
unstable product.

6. The drug deterioration is
caused by:
 Physical changes
 Chemical changes
 Oxidation
 Photolysis
 Polymerisation
 Optical isomerisation
 Microbial stability
FACTORS AFFECTING STABILITY

7. STABILITY TESTING
Classical methods ASS

8.  Aging of drug
products
 Packages
 Expiry dates &
expiration dating
 Shelf life
How to manage the problem of instability of
medicines???

9. Expiry Date Control:
Maintenance of expiry registers
Computerization
Verification & checking
Stock replacement
‘Expiry date’ is the date up to which the dosage form is
expected to meet with the standards of identity, purity,
potency, safety & quality when stored in specific
conditions.
‘Expiration date’ is defined as the time period in which
the product will remain stable when stored under the
suggested/ recommended conditions.

10. DESIGN AND LAY OUT OF A DRUG STORE
i. PREMISES AND EQUIPMENTS
ii. PEST CONTROL
iii. FIRE PRECAUTIONS
iv. SECURITY MEASURES
v. STORAGE PATTERN

11. RECALL PROCEDURES
 Communication
 Product handling
 Record keeping
DRUG RECALL
REASONS FOR RECALL
Potency problems
Labelling/packaging problems
Miscellaneous product problems
Dissolution
Manufacturing discrepancies
Contamination

12. Important steps for a pharmacist to take to handle
recalls effectively are:
Establish procedures
Document what is performed
Use good judgement