Current and Upcoming EU Regulations and Industry Standards


Pharma IQ
06/21/2011

The Pharmaceutical supply chain involves many members who are required to meet various global requirements and industry standards during the process of handling, storing and distribution of environmentally sensitive pharmaceutical products. Many of the pharmaceutical products consist of biopharmaceuticals, which is a fast-growing market. Such products are very temperature sensitive, and hence the cold chain is a very important factor in the pharmaceutical supply chain. Medicines which require a particular storing condition should be distributed in the regulated manner, as prescribed, so that the quality is not adversely affected.

The key regulatory guidelines and industry standards are set by WHO (World Health Organization), Food and Drug Administration, US Pharmacopeia, Health Canada and the European Union, among others. In the near future, most of the global pharmaceutical products will require cold-chain handling and with the complex global distribution chains, it is important to deliver medicines safely to patients in far-away lands. Visibility and control, along with risk analysis is of the utmost urgency. This will ensure chain monitoring in order to maintain the temperature and follow the country-specific regulations, while working on air, sea or road transportation.

The current EU regulations require that the quality of the products be maintained throughout the entire distribution network, without any alteration of the properties. Along with the quality, the wholesalers must also comply with all the guidelines of proper distribution as prescribed by the EU Commission. The storage conditions must be observed during transportation, so thatthere is no contamination. In   ddition, it should be noted that proper turnover of the stored pharmaceutical products take place and that the products are stored safely. The correct products should be delivered to the proper addresses within the stipulated time. The suppliers should also maintain a tracing system in order to detect any faulty products, and in this case be able to recall the products.

The EU regulations for pharmaceutical cool chain also stipulate that there should be representatives to manage each distribution point, so that the quality is implemented. This person should be suitably qualified, the exact qualification being specified by the member state of the European Union, in which the wholesaler resides. The products that are stored in warehouses should be properly handled and the management handling these should be properly trained in these duties, with the training sessions being recorded.

All important documents should be ready with the wholesalers and should be produced on
demand by competent authorities. The wholesalers should place orders only to authorized
suppliers of pharmaceutical products in accordance with the directives provided in the EU
regulations. There should also be written procedures regarding the distribution activity, such
as storage, cleaning, maintenance, security and so on. All records pertaining to the
consignments while being transported, and the removal of certain stock, client orders and plans
for recalling certain products should be mentioned and these procedures should be duly signed
and dated by the person responsible.
All significant records must be maintained, so that any important activity or event can be traced
and should be clearly available for validation, whenever demanded. Such records should be
maintained at least for the past five years. Every purchase and sale of pharmaceutical products
should be recorded with the date and name of the product. This should be maintained between
the manufacturers and wholesalers, as well as between wholesalers. The origin and destination
should be clearly traceable through the use of batch number, for easy identification of the
supplier and the receiver.
The premises should be suitable for proper conservation and distribution of the pharmaceutical
products, with proper monitoring of the activities. The deliveries at the receiving bays should
be protected from being affected by bad weather conditions, during unloading, with separate
areas for receipt and storage. When containers are delivered, industry standards require that
they should be thoroughly checked out for damage and also the consignment must be matched
with the order. Some medicinal products that require specific storage temperatures should be
stored accordingly and these should be immediately identified upon receipt and stored according
to the written instructions provided.
The industry standards for cold chain management also requires that the pharmaceutical
products should be stored according to the specifications provided by the manufacture, so that
there is no deterioration of the product, on account of light, heat, moisture or any other
conditions. The temperature for the storage should be regularly monitored and maintained. This should be done with the help of temperature recording devices and all parts of the storage area should be covered by the required temperature.

There should be no dust, litter or pests in the storage facilities and the wholesaler should also take care to see that there is no spillage, leakage or breakage and that the products are not affected by any micro-organisms or contaminated in any other way. Stock rotation should be properly done, with the first-in-first-out method being followed. It should be seen that products that have crossed their expiry date should be separated from the rest of the good stock and the former should not be supplied or distributed under any condition. There should be no broken  seals or any kind of damage to the packaging. On any such suspicious observations, the product should be immediately withdrawn from the sales point and kept separated, so that they don’t  contaminate the rest of the stock.

Whenever supplies are made to authorized persons, it should be done along with the necessary documents giving details of the date, name, description of the pharmaceutical product and the
amount supplied, along with the addresses of both the parties. The transportation should be
done in such a manner that the medicines do not lose their identification and are not affected by
spillage, breakage, theft and are delivered safely.

There are certain industry standards for returning non-defective pharmaceutical products
back to the wholesaler. The products should be returned to the wholesaler under certain
conditions, wherein the containers should be unopened and in good condition. The goods should
also have been handled under the required proper storage conditions along with having a
remaining shelf life period that is acceptable. An authorized person should have assessed the
product thoroughly and they should keep proper records of the goods returned.
The EU regulations for cold chain management also require that emergency plans are made
for immediate or urgent recall of products and these should be available in writing. Designated
authorities should be responsible for recalls, so that it can be done in an organized and
coordinated fashion. The recall operations should be recorded, with regard to the time and other
details and competent authorities of the Member states of the EU should be informed regarding
this. In case of any recall, all receivers of such pharmaceutical products should be identified and
notified, so that the emergency plan is effective, with all who received the batch being identified.

Everyone concerned in the cold chain link, such as the wholesalers, retailers, hospital
pharmacists and others selling the medicinal products to the general public, should be notified in
case of a batch recall. This also includes the customers in other EU member states. The message
sent out for recall should clearly specify the recalled products and this stock should be securely
stored. Due to all these regulations, more and more products are being required to be handled
properly with refrigerated conditions, thus widening the cold chain pharmaceutical marketing.
Shippers are now trying to design cost-effective solutions for transportation and packaging.
Novel technologies and logistics solutions, such as thermo stable vaccines, zero energy cold
chain vehicles, battery free refrigerators are being considered. The revision involves increased
guidance for the packaged goods and for the transportation processes. A new section has been
envisaged to guide the transport service providers, so that they can offer a high-quality
management system with responsible and designated officials. More training programs will also
be provided in Europe regarding the revised industry regulations.
A perishable cargo panel will meet to address certain important rules regarding perishables,
such as standard labeling and marking for all containers. So far, the pharmaceutical industry
was unwilling to put such labels, due to fear of theft, but the authorities need to know the
contents in the containers. The temperature in the cargo compartment also needs better control.
It should not be dependent on the shipper alone. Environment control systems have to be
implemented, though this might entail more cost. There is a proposal for ambient temperature
control of products all the way from loading to customer recovery. More expanded use of pallet
shippers with active temperature control need to be used. Water-based refrigerants are being
suggested, as they improve cost and minimize cost. The new regulations will address shipment
protection for longer durations, suitable for both summer and winter environments.

At the 4th International Symposium on Cool Chain Management held at Germany in
August, 2011, these challenging issues in the pharmaceutical supply chain will be discussed. The
EU regulations which are currently required will be reviewed and some changes are expected,
as the cold chain logistic solutions need to be updated. Both quality and cost need to be
balanced, while considering the present industry standards.

The upcoming EU regulations involve improving the selection and validation of transport
partners with the use of RFID and TTI labels. The last mile of transportation should be identified
and risks should be managed in this part of the cool chain. All industry standards along with
current and upcoming regulations should be implemented. It was suggested that modern
technical solutions, such as multiuse thermo containers and temperature data logger be used.
Thus, it is seen that the industry guidelines and regulations for packaging and transportation of
pharmaceutical goods will be advancing significantly. Such temperature-sensitive products need
to be provided with best practices set in for effective management of the cold-chain.