Good Storage Practice Reference: World Health Organization (WHO) Technical Report

Series (TRS), No. 908

TECHNICAL TEAM

(5)GPP- STORAGE AND STOCK MANAGEMENT

• The expiry periods of pharmaceutical products have meaning only if the products are stored under properconditions, otherwise, products are likely to lose their potency before the actual date of expiry.

Every community pharmacy, however large or small, needs to store and manage its medicine stockseffectively. There must be systems to ensure

• Secure storage.• Clean and correct environmental

conditions during storage.• Accurate and effective record keeping.• Effective stock rotation and expiry

monitoring.• Effective fire and theft prevention.• Effective rodent/ pest control

1. Avoid wet and slippery floor.

2. Proper instructions for slippery floor to be in place.

Sample Stock record cardGeneric Name: XXX CAPS. Dosage form: CAPSULES Code No: XXXX 2014

DATE SUPPLIER QTY RECEIVED

QTY ISSUED

BALANCE REMARKS SIGNATURE

10/12/14

Xxxx Ltd. 100BXS 20BXS 80 10//2015 MOHHAMAD

Consequences can be VERY Expensive!!

Sample Stock record card

1. Use liquid correction fluid.

2. No Pencil or eraser & Gel Pen.3. Don't alter any record-this is a criminal offense.

STORAGE-The need for proper storage

• The storage of medicines and other products is an important requirement of Good Pharmacy Practice.Appropriate storage of medicines is essential –

Ø To ensure that the potency is maintained.Ø To prevent deterioration/spoilage/

degradation.Ø To ensure/maintain physical integrity.Ø To ascertain that the quality and safety is

maintained throughout their shelf life.

Storage requirements need to be considered on 2 aspects :• A) Integrity Of Medicines: Medicines

Should Be Stored In Such A Way So As To Maintain Their Integrity And Potency.

• Maintain the right temperature required.

• Protect from excessive humidity.• Keep medicines away from direct

sunlight.• Protect from pests and rodents.

B) Physical location• Should be easy to locate.• Accessible.• Orderly/systematically placed.

• Storage according to temperatures is a must, no matter which pattern of storage is followed. Also,within a particular storage area, segregated storage may be maintained. In a refrigerator, for example,medicines may be stored in trays, racks and the freezer, according to the temperature required.

Whatever pattern of storage is selected, all the personnel should ensure that• The stocks are stored in an orderly

manner.• The medicines are kept back in the same

place from where they were removed. • All medicines are arranged neatly once

in a while.• The personnel should be careful while

storing the medicines.• They should not throw the medicines

haphazardly.

DONT’S

• Direct storage of cartons on the floor should be avoided because, besides being an unhealthy practice, the contents may also be damaged by moisture.

DO NOT STORE MEDICINE

CARTONS ON THE FLOOR !!

DON’T’S

• Store medicines preferably in shelves with glass shutters for visibility.

• Closed shelves further prevent dust from going in, especially where most pharmacies are located along busy roads.

• Some medicines have to be refrigerated or stored in a cool or cold place. Having a refrigerator or two(as per the need of the pharmacy) is essential to store such medicines at temperatures mentioned on the label

Refrigeration• All cold chain equipment should meet

required standards.• Vaccines should not be stored on

refrigerator door shelves as they are exposed to warmer temperatures each time the door is opened. Vaccines should always be stored on the middle shelves of the refrigerator.

• Consumable products like juices, energy drinks, etc., should not be stored along with medicines in refrigerators. If required, they may be kept in a separate refrigerator.

Temperature/climatic conditions:

• An air-conditioned environment where temperature can be controlled is recommended for pharmacies.

• Air conditioning offers the option of setting the temperature as per requirements.

• It is ideal to have an air conditioner to maintain the temperature below 25 ° C, as most medicines

• require storage below this temperature. Secondly, this temperature is pleasing to both the staff and the

• visiting customers, too.• In the absence of an air conditioner, circulating fans

may be used.

“YOU CAN BE A THERMOMETER.If you feel hot, your medicines probably

too feel the same.”

Humidity or moisture control• Moisture or humidity can

adversely affect the stability of medicines such as tablets, capsules, powders.

• Gelatin capsules become soft, and swell on absorption of moisture

• The presence of moisture may encourage the growth of microbes. It is therefore essential to control humidity.

• Calibrated thermometers and manometers can be used to detect temperature and humidity in the pharmacy.

• Temperature charts should be available for ready reference.

ABC PHARMACY TEMPERATURE CHARTArea: DISPENSING AREA

DATE TIME TEMP in ᵒC MONITORED BY

Storage conditionsSTORAGE CONDITIONS SPECIFICATIONSCold Any temperature not

exceeding 8º C (Between 2º C and 8º C)

Cool Any temperature between 8º C and 25º C

Room temperature Temperature prevailing in a working area

Warm Any temperature between 30º C and 40º C

Excessive heat Any temperature above 40º C

STABILITY ISSUES:FACTORS

LIKELY EFFECTS ON DRUG

Exposure to light Increased oxidation or photochemical degradation

Exposure to air. Increased oxidationLoss of vapour. Loss of water or volatile

solventsAccess to microorganisms Increased contamination,

growth, spoilage andpossible harmful effects

Access to moisture. Hydrolysis, damage to powder, tablets and capsules

(6) STANDARD OPERATING PROCEDURES

- It is important that the Pharmacy should write out its own SOPs for the different activities in the pharmacy

A SOP SPECIFIES IN WRITING:- WHAT should be done- WHEN it should be done- WHERE it should be done- By WHOM it should be done

- SOPs is a useful tool for Training of a new staff/recruit

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