Transcript
Storage is the physical process of storing or
housing drug materials in a specified area.
Schedule P
WAREHOUSING OF DRUGS
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
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
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.
The drug deterioration is
caused by:
Physical changes
Chemical changes
Oxidation
Photolysis
Polymerisation
Optical isomerisation
Microbial stability
FACTORS AFFECTING STABILITY
Aging of drug
products
Packages
Expiry dates &
expiration dating
Shelf life
How to manage the problem of instability of
medicines???
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.
DESIGN AND LAY OUT OF A DRUG STORE
i. PREMISES AND EQUIPMENTS
ii. PEST CONTROL
iii. FIRE PRECAUTIONS
iv. SECURITY MEASURES
v. STORAGE PATTERN
RECALL PROCEDURES
Communication
Product handling
Record keeping
DRUG RECALL
REASONS FOR RECALL
Potency problems
Labelling/packaging problems
Miscellaneous product problems
Dissolution
Manufacturing discrepancies
Contamination
Important steps for a pharmacist to take to handle
recalls effectively are:
Establish procedures
Document what is performed
Use good judgement
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