ORGANISATION OF PHARMACEUTICAL PRODUCERS OF INDIA

OPPI GUIDELINES

ON

COLD CHAIN PHARMACEUTICAL PRODUCTS

 CONTENTS

™ Message 1

™ Foreword 2

™ Acknowledgement 3

™ Introduction 4

™ OPPI Guidelines on Cold Chain Management 6

♦ Guidelines for Storing and Handling Cold Chain 8

Pharmaceuticals at Seaports and Airports
♦ Guidelines for Customer Clearance and Sample 14
Testing of Cold Chain Products by the ADC office
♦ Guidelines for Using Refrigerated Vans for 16
Transporting Cold Chain Pharmaceutical Products
♦ Guidelines for Stockists / Distributors for Handling 21
Cold Chain Pharmaceutical Products
♦ Guidelines for Retailers / Chemists for Handling 30
Cold Chain Pharmaceutical Products

™ Members of Materials Management Committee 35

 MESSAGE

Medicines that require controlled temperature storage conditions need to be

handled with special care not only at the factory, but throughout the distribution
chain until it reaches the end customer. If the temperature is not maintained at
the required level, the product cannot deliver its promise.

In a country like India with its vast distances and varied infrastructure, cold chain
management poses major challenges. Everyone who has a role in the
distribution chain, like the transporter, the truck driver and the attendant at the
retail outlet, need to know the why and how of cold chain management.

It is the manufacturer’s duty to update everyone in the pharmaceutical

distribution chain and to ensure that the proper procedure is followed.

I hope this OPPI initiative will serve this purpose.

Ranga Iyer
President, OPPI
8th August, 2009
Mumbai

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ACKNOWLEDGEMENT

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 INTRODUCTION

Drugs are complex entities and many of these are temperature sensitive in
nature. This entails them requiring precise and continuous temperature
conditions in transit in order to retain their potency and resultant efficacy.

Many life saving drugs including biotech products and vaccines fall under such
category. Any break in the cold chain process for such drugs can lead to
immediate denaturing or deterioration in their quality parameters. It is imperative
that a careful consideration is given by all concerned including government
agencies and the seaports and airports while providing storage space at their
warehouses for such drugs.

A world class cold chain infrastructure and its efficient management within the
country will also help the domestic Indian Pharmaceutical companies immensely,
as they explore more and more opportunities to export temperature sensitive
Pharmaceutical products to the global market. This is also the need of the hour,
as the Government seeks to improve access to medicines across rural India. The
Drug Controller General of India, Dr. Surinder Singh well recognises the need for
cold chain management for temperature sensitive Pharmaceutical product and is
instrumental in driving the initiative of creation of Pharma Zones in Indian ports.
Modern cold chain logistics management will play a key role in ensuring right
product quality standard that India will export.

Realising a critical need, the Materials Management Committee of OPPI has

prepared this comprehensive booklet titled ‘OPPI Guidelines on Cold Chain
Pharmaceutical Products’, which covers Standard Operating Procedures (SOPs)
for various stakeholders.

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The preparation of these guidelines has been made possible due to the efforts of
the Materials Management Committee, spearheaded by its following members:

• Mr. Ashok Bindumadhavan, Eli Lilly (Project Leader)

• Mr. Sikander Yarkhan, Chiron Panacea
• Mr. Vasanth Kumar, GlaxoSmithKline Pharmaceuticals
• Mr. Rakesh Prasher, Ranbaxy
• Mr. Arun Manjeshwar, Roche
• Mr. Avinash Baadkar, Sanofi-Aventis
• Mr. Krishna Parab, Sanofi-Aventis
• Mr. Vishwanath Iyer, Wyeth

We convey our sincere thanks to each one of them.

Special care has been taken to ensure that this document conforms to the
prescribed standards and regulations. We hope that, ‘OPPI Guidelines on Cold
Chain Pharmaceutical Products” will meet the expectations of the stakeholders of
the Indian Pharmaceutical Industry.

Ajit Singh Tapan Ray

Chairman Director General
OPPI Materials Management Committee OPPI

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 OPPI Guidelines on Cold Chain Management

What are Cold Chain Medicines?

Cold chain medicines are those that require special temperature-controlled cold
storage to maintain their quality and efficacy. There are two commonly
recommended temperatures specified on the labels of cold chain products:

1. Products requiring temperatures of between 2°C and 8°C

2. Products requiring temperatures of around (-10°C) and (-20°C)

What is Cold Chain Management?

A cold chain is an uninterrupted series of storage and distribution activities that

maintains products at a required temperature range of 2°C and 8°C or between -
10°C and -20°C as per their requirements.

Why is Cold Chain Management Important?

Cold chain management in pharmaceuticals is important to ensure that the right

quality is maintained during storage and transportation, and also to meet the
regulatory commitments. Regulatory guidelines and standards around the world
focus on the right storage and transportation, and adhering to these standards is
important.

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Cold chain products are sensitive biological substances that can become less
effective or lose their potency if not stored properly. For example, products that
are required to be stored between 2°C to 8°C could become ineffective if:

i. They are frozen or stored below 2°C

ii. Exposed to temperatures above 8°C
iii. Exposed to direct sunlight or fluorescent light

The loss of potency is cumulative and irreversible.

In short, when products are exposed to conditions outside the established

temperature range, their quality may be negatively affected, reducing their
assigned shelf life, diminishing their effectiveness or making them ineffective.
Though the exposed product may look the same it will not have the required
potency, and have a direct impact on patient safety.

So it is important that the right temperature is maintained throughout the

distribution chain, starting from the dispatch of the product from the
manufacturing site to when it reaches the patient.

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 Guidelines for Storing and Handling Cold Chain Pharmaceuticals at
Seaports and Airports

Standard Operating Procedures:

Cold chain pharmaceutical storage and handling at airports and seaports

requires special care and attention. Since multiple products are stored and
handled at seaports / airports, personnel may not be able give cold chain
pharmaceutical products the attention they deserve. Therefore airport/ seaport
authorities should have documented Standard Operating Procedures for storing
and handling pharmaceuticals, with personnel strictly adhering to them.

Training:

A training programme should be put in place to educate personnel on Standard

Operating Procedures for handling the pharmaceutical consignments. Only
trained personnel should be allowed to handle pharmaceutical consignments.
There should be a documented record to show that new employees have
undergone training, and periodic refresher courses for all employees.

Storage Infrastructure:

• There should be dedicated cold rooms for pharmaceutical items.

Pharmaceuticals should not be stored along with food items or flowers.
• There should be separate cold rooms with specific temperature zones:
ƒ For storage between 2°C and 8°C
ƒ For storage between -10°C and -20°C
ƒ For storage between 15°C and 25°C

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• The facility should have adequate space and infrastructure for loading and
unloading cargo, with temperature-controlled chutes connected to the
aircraft so that cargo is not exposed to heat or rain.

• The facility should have adequate handling facilities/ equipment to

ensure effective handling of BUP (built-up pallets) and unit load
devices (ULD) arriving from the shipper’s factory.
• The facility should have proper X-ray units that can completely scan
BUPs or ULDs.
• There should be adequate material handling equipment to ensure
proper storage of pallets/ ULDs to the maximum binning height.

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 • There should be adequate height for release access gates so that both
main deck and lower deck pallets can be made in the cool chain facility.
• There should be proper ULD building platforms, so that the cargo is not
trampled while it is being built up and to avoid shoe impressions.

Qualification of Cold Rooms:

• Temperature mapping needs to be done to ensure uniform temperature in

all parts of the cold room.
• Professional agencies should do the qualification by keeping multiple
temperature monitors covering all parts of the room.
• Temperature mapping should be done under the following conditions:
o When the cold room is empty.
o When it has a full load.
o At different times of the year, preferably once in summer and once
in winter.
• The hottest and coldest points (areas) should be identified.
• Cold rooms are qualified according to the temperature mapping data, and
the qualification report should be documented and made available for
reference later.
• Re-qualification must be done preferably twice a year.

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Continuous Temperature Monitoring:

ƒ Cold rooms should have a datalogger to record temperatures on a

continuous basis 24 x 7.
ƒ One datalogger should be placed at the hottest point identified during the
qualification, and another at the coldest point.
ƒ There should be an alarm or hooter to indicate when the temperature goes
outside the prescribed limits in the cold room.
ƒ Temperature dataloggers should be calibrated annually to ensure
accurate recording.
ƒ Temperature dataloggers should have sufficient battery and shelf life.
ƒ They should be replaced every three years.

Temperature-Controlled Examination Area:

ƒ There should be a temperature-controlled area, preferably between 15oC

and 25oC, so that the product is not exposed to extreme temperatures
during examination.
ƒ The examination area should be just outside the storage cold rooms so as
to minimize excursion time.
ƒ It should be made mandatory for customs and drug authorities to examine
the stocks only in this exclusive temperature-controlled examination area.
ƒ The testing lab must have modern equipment so that the cargo can be
checked/ analysed for identification without opening the cargo containers.

Power Backups:

ƒ There should be a dedicated power backup to ensure uninterrupted power

supply to cold rooms.
ƒ There should be separate power backups for the cold room and the alarm/
hooter. The hooter can be connected to the inverter backup and the cold
room to the auto generator set.
ƒ Power backups should be routinely tested at night or on holidays to test
their effectiveness.

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Transportation and Handling:

ƒ Only trained personnel should handle pharmaceutical consignments.

ƒ Care should be taken to ensure that export cargo is unloaded from trucks/
vans directly or very near to the cold storage rooms to minimize exposure.

ƒ There should be adequate refrigerated containers/ vans to ensure that the

cargo, after being released from the cool chain facility, is maintained in the
cold chain till the final loading into the aircraft.
ƒ In the case of imports, the goods, after customs release, should be loaded
into the truck through a gate that is very near the cold storage room. There
should be sufficient protection to ensure that the temperature is
maintained and there is no exposure to extreme climate.
ƒ The goods should be immediately transferred to the cold storage after
being unloaded from aircraft or ships. Any reconciliation or verification of
stock by port authorities should be done only inside the cold storage to
avoid any temperature excursions.
ƒ Airports should have special docking stations to connect the cold storage
rooms through chutes or special passages to the aircraft to ensure speedy
loading/ unloading at the right temperatures.

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Preventive Maintenance:

ƒ There should be a documented preventive maintenance programme for all

major equipment so that they are always in good running condition.
ƒ Critical equipment should also be replaced in a time-bound manner to
ensure they are always in good condition.
ƒ Trained maintenance personnel should be always on duty to attend to any
malfunctions and also oversee periodic servicing.
ƒ Critical spares inventory should always be maintained for speedy
replacement.

Contingency Plan:

ƒ Personnel should be trained in a documented procedure in cases of cold

room breakdown or any other event that compromises product safety.
ƒ The list of contact numbers should be available so that the necessary
people can be immediately contacted. Repair and maintenance people
should be available at the site to repair equipment immediately.
ƒ There should be tie-ups with regional service centres so that they can be
contacted and can reach at short notice to repair major problems.
ƒ All efforts should be made to minimize temperature excursions and
transfer or restore products to the prescribed temperature storage limits.

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Guidelines for Customs Clearance and Sample Testing of Cold Chain
Products by the ADC office

• The customs, Assistant Drug Controller’s (ADC) office and port authorities
should give top priority to clear exports/ imports of cold chain products to
ensure that they are not exposed to adverse temperatures.

• Customs and the ADC office should process documents in advance to

speed up customs clearance.

• Customs and ADC should do the examination of cold chain stocks in the
cold room itself to minimize temperature excursions.

• Customs/ ADC office should not take out samples for testing at ports as
opening the cold chain packing will compromise the integrity of the packs
and lead to temperature excursions. They can request for samples, if
required, in advance and the importer or exporter concerned can give
them in separate cold chain packing.

• The ADC office should not test cold chain products more than once a year
unless there is any issue with the importer/ exporter that may necessitate
further testing.

• Cold chain samples at the ADC office for further testing/ forwarding to
government or other private testing laboratory should be stored in a proper
cold chain infrastructure and maintained at the required temperature.
There should be proper power backup arrangements to ensure an
uninterrupted cold chain.

• Samples of bulk drugs at ports should be taken by GMP trained personnel

in a sterile environment to avoid any contamination.

• If the ADC office intends to send samples of any cold chain consignment
to a testing laboratory, proper packing and transportation arrangements

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 should be made to ensure that proper temperatures are maintained during
transit.

• The ADC office should ensure that testing laboratory to which the samples
are sent for testing has adequate cold chain infrastructure for storage and
testing.

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 Guidelines for Using Refrigerated Vans for Transporting Cold Chain
Pharmaceutical Products

Identification of Refrigerated Vans:

ƒ Refrigerated vans should be qualified and validated by QC professionals

to ensure that recommended storage conditions are maintained uniformly
in the van. Qualification should be done by keeping sufficient temperature
monitors to cover all parts of the van.
ƒ The qualification should be done in the following conditions:
o Stationary with an empty load.
o Stationary with a full load.
o In a moving vehicle with a full load.
o At different times of the year, preferably once in summer and once
in winter.
ƒ Qualification should identify the hottest and coldest points in each van.
ƒ The validation report should be documented and made available for
reference later.
ƒ The vendor should have an understanding of the sensitivity of
pharmaceuticals and should preferably have worked with pharmaceutical
companies earlier.
ƒ The vendor should have a good fleet of vans and experience in handling
refrigerated vans.

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Requirements of a Refrigerated Van:

ƒ Refrigerated vans used in the pharmaceutical trade should not be used

to transport food or other products to minimise pest infestation and avoid
contamination of any form.
ƒ There should be an alarm in the refrigerated van to indicate when the
temperature goes out of specified limits.
ƒ There should be a power backup for the refrigeration unit so that it
continues to function even if the main engine is not working.
ƒ The vans should be in a roadworthy condition and have a fitness
certificate issued by the RTO.
ƒ The refrigeration unit should have thermostatic control to regulate the
temperature within set limits.
ƒ The refrigeration unit should be of a reputed brand.
ƒ The van should have a small window for loading and unloading.
ƒ There should be a temperature display in the driver's cabin.
ƒ There should be collapsible plastic curtains on the door of the van.
ƒ Drivers of the refrigerated vans should have mobile phones with national
roaming to keep track and communicate at all times.

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Temperature Monitoring in Dataloggers:

ƒ Refrigerated vans should have re-usable dataloggers to record the

temperature in transit.
ƒ One datalogger should be placed at the hottest point and another at the
coldest point.
ƒ Temperature dataloggers should be calibrated annually to ensure
accurate recording.
ƒ Temperature dataloggers should have sufficient battery and shelf life.
ƒ The dataloggers should be replaced every three years.

Training Plan:

ƒ Refrigeration van drivers and service operators must undergo mandatory

training before they commence work.
ƒ The drivers, before commencing any trip, should have a clear
understanding of the temperature requirements of the product they are
transporting.
ƒ There should be a record of past training undertaken by the drivers.
ƒ Drivers should be trained in a regional language they are comfortable in.
ƒ The Do’s and Don’ts list of requirements should be prominently displayed
in the van.

Loading Guidelines:

ƒ The vehicle must be clean.

ƒ The required temperatures and alarms must be set as per requirements.
ƒ The van should be run at the required temperature for at least 1-2 hours
before loading is started.
ƒ The datalogger should be restarted and set.
ƒ Pallets must be placed on the floor of the vehicle.

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 ƒ Loading should be done through a small window to minimize temperature
excursion.
ƒ Loading should be done within a short time span. If the temperature goes
up considerably, loading should be staggered to minimize excursions.
ƒ Stocks should be placed in such a way that there is air flow to all parts of
the van. There should be at least a six-inch gap between the stocks and
the walls, and a one-foot gap from the ceiling.
ƒ Productwise and batchwise segregation should be done to minimize mix-
ups.
ƒ After the loading is complete, check the temperature for 1-2 hours to
ensure that it is maintained property before starting the journey.

Unloading Guidelines:

ƒ The dataloggers should be monitored to check if the required temperature

was maintained during transit.
ƒ Unloading should be done through a small window to minimize
temperature excursions.
ƒ Unloading should be completed within a minimum stipulated limit.

Preventive Maintenance Programme for Refrigerated Vans:

ƒ There should be an annual re-qualification to ensure that the refrigerated

van is capable of maintaining the right temperature.
ƒ The vehicle and refrigeration unit should be serviced periodically.
ƒ There should be a “health checkup” of the refrigeration unit at least once a
year to check if it’s working properly.
ƒ Ideally, a re-qualification should be done if a major part in the refrigeration
unit is changed, to assess if the refrigeration unit is working as per initially
validated standards.
ƒ There should be a record of preventive maintenance, accessible to users
of the van’s services.

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Contingency Plan:

ƒ There should be a documented procedure, with training, for drivers to deal

with contingencies like refrigeration breakdown, or any other event that
compromises product safety.
ƒ A list of contact numbers should be available in van so that the people
concerned can be immediately contacted.
ƒ There should be tie-ups with regional service centres so that vans can be
rushed there for repairs.
ƒ All efforts should be made to minimize temperature excursions and
transfer or restore the products to the prescribed temperature storage
limits.

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 Guidelines for Stockists / Distributors for Handling Cold Chain
Pharmaceutical Products

Standard Operating Procedures:

Distributors/ wholesalers are important stakeholders in pharmaceutical

distribution. They play a vital role in proper cold chain management as products
spend a considerable time in their custody.

It’s quite common for distributors/ wholesalers to handle multiple products of

different companies, which makes storage and handling complex. Hence, it is
important to have comprehensive documented standard operating procedures so
that each product is stored and handled at the right temperature as prescribed by
the manufacturers.

Training:

There should be a training programme for personnel on standard operating

procedures for handling pharmaceutical consignments. Only trained personnel
should be allowed to handle pharmaceutical products. There should be a
documented record to show that new employees have undergone this training
and refresher courses at regular intervals.

Employees handling packing and dispatch should be specifically trained in

packing procedures.

Receipt of Products:

ƒ The pack containing the products should be physically inspected. It should

not be dirty, damaged or torn and safety seals or tapes should be intact
and not tampered with.

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 ƒ After unpacking, the product should be immediately transferred to the
storage facility. Instructions on the product packages, labels and invoice
should be followed.
ƒ The supply site should be notified immediately if any temperature
deviation is noticed.

Storage:

ƒ Stockists / distributors should have adequate cold storage infrastructure in

the form of cold rooms or special refrigerators to store pharmaceutical
products at 2oC to 8oC. Products requiring sub-zero temperatures should
be stored in a deep freezer.

ƒ The exclusive areas where the cold chain products are stored should be
clean.
ƒ Products should be stored in an orderly manner in the racks.
ƒ Medicines should be stored according to company/ product/ batch.
Products that are expiring first should be placed in the front.
ƒ The practice of FEFO (First Expiry First Out) should be followed.

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 ƒ Medicines should be stored within the specified storage area only. In no
case should cold chain products be stored outside the refrigerator/ walk-in
cooler.
ƒ Entry to the storage room should be restricted to authorized personnel.
ƒ Always plan for sufficient storage space in the refrigerator to
accommodate stocks purchased.
ƒ Orders should be placed once a week to stagger purchases and manage
storage capacity.

What a domestic refrigerator used to store medicines should be like

i) The refrigerator should be used exclusively to store medicines.

ii) It should maintain a temperature of between 2ºC and 8ºC without
major fluctuations. The freezer compartment should maintain a
temperature of below -15ºC. If the refrigerator is not frost-free, ice
should not be allowed to build up more than a quarter inch.
iii) It’s better to use special refrigerators like Visicoolers and Ice Lined
Refrigerators that are now available without freezers. These are
capable of maintaining uniform temperatures of 2ºC to 8ºC much better
than domestic refrigerators. Among domestic refrigerators, frost-free
models are recommended. These refrigerators do not have heating
cycles, but remain frost-free with low levels of frequent warming
temperatures.

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iv) The refrigerator should be well-maintained and not require frequent
repairs.
v) The seals should be in good condition and there should be no water or
coolant leaks.
vi) The door should close properly and automatically (it should comply
with manufacturer’s directions on refrigerator leveling).
vii) Food, beverages and other drugs should not be stored along with
medicines in the same refrigerator. This interferes with temperature
control and may contaminate the medicines.

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How to store medicines in a domestic refrigerator in an appropriate way

a) Placement of the refrigerator – The refrigerator must be placed away from

direct sunlight and any other source of heat -- for example, a warm
external wall. Doors must not be opened unnecessarily.
b) The power source -- Accidental disconnection from the power source can
cause damage to the medicines, particularly if it is unnoticed for a long
period. Ideally, the power source must be isolated and kept under lock and
key.
c) Place water bottles or ice packs/ gel packs inside the refrigerator – This
will help stabilize the temperature in the refrigerator compartment as cold
air is distributed from the freezer in most frost-free refrigerators.
d) Place water-filled plastic containers in the lower shelves and door – This
reduces warming periods when the refrigerator is opened. This is
particularly useful if the refrigerator breaks down because of a power
shutdown or any other cause.
e) Stabilize the temperature of the refrigerator before stocking – This will
minimize the effect of temperature variations on medicines.
f) Keep medicines in plastic containers – This allows easy identification of
medicines, thus minimizing the time the door is kept open. Avoid glass
and metal containers since they offer less buffering against temperature
deviations. Air circulation between enclosed plastic containers can be
maintained by not packing them tightly.
g) Door of the refrigerator – Medicines should not be stored in the door of the
refrigerator. The door lining should be checked regularly for any leakage,
and worn-out linings replaced immediately.
h) Chiller of the refrigerator – Medicines should never be stored in the chiller.
i) Monitoring the temperature inside the refrigerator – Each refrigerator
should have a good quality temperature monitoring device. The device
should be placed in a central location and the temperature recorded
regularly every day.

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Power Backups:

ƒ There should be a dedicated power backup to ensure uninterrupted power

supply to the cold rooms and an uninterrupted cold chain.
ƒ The power backups should be routinely tested at night or on holidays to
test their effectiveness.
ƒ Instead of a generator, the refrigerator should be connected to an inverter
so that power is automatically restored.

Qualification of Cold Rooms/ Refrigerators:

• There should be an annual qualification of cold rooms / refrigerators to

ensure uniform temperatures in all parts of the cold room / refrigerator.
• The qualification should be done by professional agencies with multiple
temperature monitors, covering all parts of the room.
• The temperature qualification should be done under the following
conditions:
o In an empty cold room / refrigerator.
o With a full load.
o At different times of the year, preferably once in summer and once
in winter.
• Qualification should identify the hottest and coldest points in each cold
room / refrigerator.
• Always remember that for medicines requiring temperatures of between
2ºC and 8ºC, any exposure to below 2ºC is far more dangerous than
exposure above 8ºC. Products exposed to sub-zero temperatures may
completely lose their potency, rendering them useless. Adequate
precautions should be taken to set the thermostatic controls in the cold
room / refrigerator to prevent such excursions.
• The qualification report should be documented and made available for
reference later.

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Temperature Monitoring:

Proper temperature monitoring is key to cold chain management. A temperature

monitoring device should be placed in the coldest point in the storage unit,
adjacent to the medicines. The temperature must be read and documented at
least twice each day, once when the premises opens and once at the end of the
day. Immediate action must be initiated to correct storage temperatures that are
outside the recommended ranges. All staff members working with medicines
should be familiar with proper temperature monitoring. Mishandled medicines
should not be administered.

ƒ Cold rooms / refrigerators should have a datalogger to record

temperatures on a continuous basis 24 x 7.
ƒ An alarm or hooter should go off if the temperature goes outside the
prescribed limits in the cold room/ refrigerators.
ƒ Temperature dataloggers should be calibrated annually to ensure
accurate recording.
ƒ Temperature dataloggers should have sufficient battery and shelf life.
ƒ Dataloggers should be replaced once every three years.

A round-the-clock monitoring system might be considered to alert staff to

emergencies after working hours, particularly if large medicine inventories are
maintained.

Packing for Despatch:

ƒ Packing must be done as per the prescribed system or as recommended

by manufacturers
ƒ Trained persons should be used for packing
ƒ Coolants (ice packs) must be conditioned in the deep freezer (temperature
between -20oC to -15 oC) for a minimum of 48 hours to five days before
use to ensure the desired effect throughout the transit period. The duration

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 of this pre-conditioning will vary depending on the ice packs used. The
optimal time to condition the ice packs should be established during the
qualification time of the packing system.
ƒ The number of ice packs and their arrangement in the thermocol box
should be as per the prescribed system.
ƒ There should be no direct contact of the ice packs with the product, as this
may damage the labels or packages and cause the product to freeze,
adversely affecting its quality and potency.
ƒ The time taken to pack the product in the assigned area, during which the
product remains outside refrigerated conditions, must be kept to a
minimum.
ƒ The temperature of the packing room must be monitored and recorded
during packing. The packaging area should be air-conditioned to minimize
temperature excursions.
ƒ A datalogger must be placed near the product without touching the ice
packs to determine the temperature of the product during transit.
ƒ Packing components must be qualified to ensure that they maintain the
right temperature taking into account:
o The means of transportation employed for distribution.
o The destination of the products to be delivered.
o The route to be used.
o The time taken to reach the destination.

Transportation:

ƒ Transportation should be done only in qualified packs that can maintain

the required temperature during transit.
ƒ Only trained personnel should do transportation and delivery.

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Preventive Maintenance:

ƒ There should be a documented preventive maintenance programme for all

major equipment so that they are always in good running condition.
ƒ There should be an annual maintenance contract with the supplier /
service provider for important equipment like cold room, refrigerators,
freezers, gensets, inverters, airconditioning units etc.

Contingency Plan:

ƒ Personnel should have a documented procedure, with training, to handle

contingencies like cold room / refrigerator breakdown or any other event
that compromises product safety.
ƒ A list of contact numbers should be available so that the necessary people
can be immediately contacted.
ƒ There should be tie-ups with regional service centres they can be
contacted and can reach at short notice to repair major problems.
ƒ All efforts should be made to minimize temperature excursions and
transfer or restore the products to the prescribed storage limits.

Excursion Handling:

This is a very important part of cold chain management. Any temperature

excursion during storage and distribution should be recorded and immediately
reported to a quality assurance (QA) representative or a person responsible for
the cold chain. The manufacturer concerned should also be notified of such
excursions.

The QA representative should assess the potential effect on the safety, efficacy
and quality of the product. Till that time, the suspect medicines should be isolated
in a refrigerator or cold room in a container labeled “Quarantined”. They should
not be used until advised.

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Guidelines for Retailers / Chemists for Handling Cold Chain Pharmaceutical
Products

Training:

There should be a programme to train personnel on standard operating

procedures for pharmaceutical consignments. Only trained personnel should be
allowed to handle pharmaceutical products. A retailer/ chemist stores different
products of multiple companies. So the focus should be on making the personnel
aware about the specific storage and handling requirements of each product.

Purchase of Cold Chain Medicines:

• Cold chain medicines should be purchased only from the authorized

stockist of the manufacturer or marketing company. No purchases should
be made from unauthorised sources as you can never be sure about the
quality and genuineness of the medicine. Besides, you can never be sure
if the products were stored properly.
• Retailers should ensure that the stockist/ wholesaler supplying the
medicines maintains the cold chain properly during storage and transit. If
not, he should report to the manufacturers and switch to another stockist
who follows the correct practices.

Receipt of Products:

• Physically inspect the temperature and expiry date of the pack. Ensure
that it is within the stipulated range. The pack should be intact with seals
and tapes and not tampered with.
• Never accept stocks from the stockist if they don’t have proper
temperature-controlled packing or you have reason to suspect that the
temperature has not been maintained properly in transit.

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 • If you or your personnel personally visit the stockist to buy the medicines,
take a full shipper in the recommended cold chain packing from the
stockist. If you are buying loose or less than shipper quantity, ensure that
you carry along special packs or containers that can maintain the proper
temperature during transit.
• Immediately transfer the stock into the refrigerator/ deep freezer as per the
storage condition prescribed on the product pack.

Storage:

• Retailers should have the necessary infrastructure to store cold chain

products -- adequate size Ice Lined refrigerators/ double-door domestic
refrigerators for storing products between 2°C and 8°C and deep
freezers for storing products at sub-zero temperatures.
• Products requiring temperatures of between 2°C and 8°C should be
stored in specially designed refrigerators like Visicoolers.

• All temperature-sensitive medicines/ vaccines should be stored in a

central place in the refrigerator or freezer as per product storage
requirements. They should not be stored in the door, chiller or at the
bottom of the storage unit, and be sufficiently away from the walls to
allow the air to circulate.

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 • There should be air-conditioning in the shop, with temperatures of
between 15°C and 25°C to store normal medicines and also to provide
the right ambient temperature to operate refrigerators and freezers.
• Eatables or beverages should not be kept in the fridge or freezer used
to store medicines.
• Glass bottles filled with water should be placed in the door and the
bottom shelf to ensure uniform temperature in the refrigerator.
• Purchases should be staggered to ensure proper storage. Do not
overstock cooling units.
• Products requiring temperatures of between 2°C and 8°C should never
be frozen.
• Stocks in the cooling units should be regularly rotated.
• All medicines should be stored batch-wise on a `First In First Out/ First
Expiry First Out’ basis.
• The temperature of the cooling units must be checked and recorded at
least twice a day. Technical assistance must be summoned in the
event of any abnormal fluctuation of temperature.
• Ideally, there should be a well-trained person in charge of operating
the cooling units.
• Never shut off the electricity at night or on holidays as it can severely
hamper the cold chain and the quality of the medicines.

Power Backup:

• Since power cuts are common it is absolutely essential to install

inverters/ auto start generators of the right capacity to ensure
uninterrupted power supply and maintain an effective cold chain.
• It is important that the power backup is automatically activated at night
or on holidays when the shop is closed to ensure that the refrigerators
or freezers are functional.

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Continuous Temperature Monitoring:

ƒ Refrigerators/ freezers should have a datalogger to record temperatures

on a continuous basis 24 x 7. If a datalogger hasn’t been installed, there
should at least be a min-max thermometer.
ƒ The datalogger/ thermometer should be kept in the centre of the
refrigerator.
ƒ Trained personnel should review the temperature data on a regular basis
to see if the correct storage temperature is maintained and take corrective
action where required.
ƒ Temperature dataloggers/ thermometers should be calibrated annually to
ensure accurate temperature recording.
ƒ Temperature dataloggers should have sufficient battery and shelf life.
ƒ They should be replaced every three years.

Preventive Maintenance:

ƒ There should be a documented preventive maintenance programme for all

major equipment so that they are always in good running condition.
ƒ There should be an annual maintenance contract with the supplier /
service provider for important equipment like refrigerators, freezers,
gensets, inverters, air-conditioning units etc.

Contingency Plan:

ƒ There should be a documented procedure to train personnel to handle

contingencies like refrigerator/ freezer/ power backup breakdown or any
other event that could compromise cold chain and product safety.
ƒ The list of contact numbers of necessary people should be readily
available so that they can be immediately contacted.
ƒ There should be tie-ups with regional service centres so that they can be
contacted and can reach at short notice for repairs of major problems.

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 ƒ All efforts should be made to minimize temperature excursions and
products should be transferred or restored to the prescribed storage limits
as soon as possible.

Educating Patients / Customers:

• When patients come to retailers to buy cold chain medicines, the buyers
should be informed about proper storage and handling.
• Retailers should provide some protective packaging to maintain the cold
chain till the medicine reaches the patient. If possible, retailers should
deliver the cold chain medicines to the patient’s home.
• Patients should be informed that cold chain medicines requiring
temperatures of between 2°C to 8°C should never be frozen.
• Cold chain products, once sold, should never be taken back by the retailer
as there’s no way of telling how the medicines were stored by the patient.
Patients should be informed about this while they are being sold the
medicines.

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 Members of the OPPI Materials Management Committee

Mr. Ajit Singh, Associated Capsules, Chairman

Mr. Ashok Bindumadhavan, Eli Lilly, Vice-Chairman
Mr. Lakshinarayana Neti, Abbott
Mr. Rajarshi Bhattacharya, Allergen
Mr. Sarang Dabadghao, Associated Capsules
Mr. Sameer Giri, AstraZeneca
Mr. Avinash Baadkar, Sanofi-Aventis
Mr. Krishna Parab, Sanofi-Aventis
Mr. Sikander Yarkhan, Chiron Panacea
Mr. Vik Thapar, Emcure
Mr. Muralidharan Nair, Ernst & Young
Mr. Niladri Biswas, Fulford
Mr. Vasanth Kumar, GlaxoSmithKline
Mr. Anand Misra, GlaxoSmithKline
Ms. V. Vijayalakshmi, Johnson & Johnson
Mr. Nitin Gokarn, Merck
Mr. B. Raveendran, MSD Pharmaceuticals
Mr. Madhukar Nayak, Novartis
Mr. B. K. Anderson, Pfizer
Mr. Siddhartha Pahwa, Piramal Healthcare
Mr. Arun Manjeshwar, Roche
Mr. Ninad Rawale, RPG Life Sciences
Mr. J. Shabarish, Sangfroid
Mr. Ashok Moodbirdri, Shreya Life Sciences
Mr. Sanjeev Suryavanshi, UCB India
Mr. Sanjeev Mehta, Wockhardt
Mr. Vishwanath Iyer, Wyeth

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 “Quality is never an accident.
It is always the result of high intention, sincere efforts, intelligent direction and
skillful execution”

-- William A Foster

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 OPPI MISSION

To make continuing contribution towards achieving

healthcare objectives of the nation while professionally
addressing the collective interests of its members
and encourage innovation for inclusive growth.
Mumbai Office:
Peninsula Corporate Park
Peninsula Chambers, Ground Floor
Ganpatrao Kadam Marg
Lower Parel, Mumbai 400 013.

Telephone : + 91 22 2491 8123

: + 91 22 2491 2486
: + 91 22 6662 7007
: + 91 22 6662 7008
Fax : + 91 22 2491 5168
e-mail : indiaoppi@vsnl.com
Website: : www.indiaoppi.com

Delhi Office :
P-37/38, Gomti Complex
Pandav Nagar, Mayur Vihar Phase I
Delhi 110 091
India.

Telephone : + 91 11 2275 9528

Fax: : + 91 11 2275 9481

Member : International Federation of Pharmaceutical Manufacturers &

Associations (IFPMA), Switzerland

© OPPI 2009