WAREHOUSING OF DRUGS

Presented by;

AISWARYA.A.TFirst year M.Pharm, Dept of Pharmacy Practice.

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

STABILITY TESTING

Classical methods ASS

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