Professional Documents
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OPPI GUIDELINES
ON
Message 1
Foreword 2
Acknowledgement 3
Introduction 4
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.
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.
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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:
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.
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OPPI Guidelines on Cold Chain Management
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:
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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:
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Guidelines for Storing and Handling Cold Chain Pharmaceuticals at
Seaports and Airports
Training:
Storage Infrastructure:
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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.
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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.
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Continuous Temperature Monitoring:
Power Backups:
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Transportation and Handling:
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Preventive Maintenance:
Contingency Plan:
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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 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.
• 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
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Requirements of a Refrigerated Van:
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Temperature Monitoring in Dataloggers:
Training Plan:
Loading Guidelines:
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Loading should be done through a small window to minimize temperature
excursion.
Loading should be done within a short time span. If the temperature goes
up considerably, loading should be staggered to minimize excursions.
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.
Productwise and batchwise segregation should be done to minimize mix-
ups.
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:
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Contingency Plan:
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Guidelines for Stockists / Distributors for Handling Cold Chain
Pharmaceutical Products
Training:
Receipt of Products:
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After unpacking, the product should be immediately transferred to the
storage facility. Instructions on the product packages, labels and invoice
should be followed.
The supply site should be notified immediately if any temperature
deviation is noticed.
Storage:
The exclusive areas where the cold chain products are stored should be
clean.
Products should be stored in an orderly manner in the racks.
Medicines should be stored according to company/ product/ batch.
Products that are expiring first should be placed in the front.
The practice of FEFO (First Expiry First Out) should be followed.
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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.
Entry to the storage room should be restricted to authorized personnel.
Always plan for sufficient storage space in the refrigerator to
accommodate stocks purchased.
Orders should be placed once a week to stagger purchases and manage
storage capacity.
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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
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Power Backups:
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Temperature Monitoring:
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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.
The number of ice packs and their arrangement in the thermocol box
should be as per the prescribed system.
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.
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.
The temperature of the packing room must be monitored and recorded
during packing. The packaging area should be air-conditioned to minimize
temperature excursions.
A datalogger must be placed near the product without touching the ice
packs to determine the temperature of the product during transit.
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:
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Preventive Maintenance:
Contingency Plan:
Excursion Handling:
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:
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:
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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:
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Continuous Temperature Monitoring:
Preventive Maintenance:
Contingency Plan:
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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.
• 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
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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
Delhi Office :
P-37/38, Gomti Complex
Pandav Nagar, Mayur Vihar Phase I
Delhi 110 091
India.
© OPPI 2009