Good Storage Practice

Airene Barlin, RPh, MPH

FDRO II

(5)GPP- STORAGE AND STOCK MANAGEMENT

• The expiry periods of pharmaceutical products have meaning only if the products are stored under proper

conditions, 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

Sample Stock record card

Generic name: Chorionic gonadotrophin Strength: 5000 I.UDosage form: InjectionCode No: 8022 Unit price: Rs 450.00

DATE SUPPLIER QTY RECEIVED

QTY ISSUED

BALANCE REMARKS SIGNATURE

10/12/14 ACE DIST 100BXS 20BXS 80 10//2015 JANE

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 Cᵒ MONITORED BY

Storage conditionsStorage conditions Specifications

Cold Any temperature not exceeding 80C (Between2C and 8C)

Cool Any temperature between 8C and 25C

Room temperature Temperature prevailing in a working area

Warm Any temperature between 30C and 40C

Excessive heat Any temperature above 40C

Stability issues:Factors

Likely Effects on drug

Exposure to light Increased oxidation or photochemical degradation

Exposure to air. Increased oxidation

Loss of vapor. Loss of water or volatile solvents

Access 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

Thank you