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Getting goods from A to B is hard enough. Finding the right way to carry those goods is another headache. Once, we loaded and unloaded goods item by item - those were the days when labour was cheap. Then the Second World War came. This mother of many inventions brought us the wood

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

en pallet. This, combined with a fork lift truck, enabled goods to be moved quickly and with less labour.

Wooden Pallets

The wooden pallet was a great idea. So good was the idea that it is still going strong to this day. However, things have changed. Pallet pooling can be

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

an expensive business. Rental and purchase costs have risen to reflect the increase in timber costs and the extra burden of fumigation and quality control.

Escalating fuel costs have taken their toll on the inevitable dedicated trips that are made to repatriate empty pallets whe

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

n imbalances occur in the supply chain. These fuel costs - and driver shortages - have also forced an examination of the space and weight taken up by the ubiquitous pallet.

The pallet is a bit like the air that we breathe. It is all around us yet we don't see it. It is easy to fo

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

rget the extra cost that the pallet adds to the value chain. Perhaps now the time has come when, in some eyes, the pallet has outstayed its welcome. Rather than being the carrier, is the pallet itself being carried by the value chain? Rather than wait for another world war, a read

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

solution has been found and is tried and tested. That is the Slip Sheet.

Enter the Slip Sheet

Slip sheets have been around for some time, especially in the U.S. where the free market has always had the knack of taking the path of least resistance. European countries ten

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

d to prefer centrally planned systems and standardization. Slip sheets lack firmly agreed international standards and this may be one of the reasons why they have not been popular in Europe. The greatest reason is ignorance. Many simply have no understanding of slip sheets and how

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

they work - so they don't bother.

So perhaps it's time to right this wrong here and now.

How Slip Sheets Work

1. Slip sheets are durable sheets of material that are designed to carry a uniform load of goods with plan dimensions (or "footprint") of roughly 1 metre squ

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

are/40 inches square (typically they may be designed to carry a footprint of 40 inches x 48 inches - 1m x 1.2m). The slip sheet is made to these dimensions plus a pull tab - an extension to the sheet - of up to 6 inches/15cm. There may be just one pull tab sticking out from under

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

the load on one side. There could, however be pull tabs on 2, 3 or all 4 sides. Slip sheets can be made of fibreboard or plastic.

2. Goods are loaded directly onto the slip sheet within the creases that border any pull tabs. A push-pull attachment on a forklift truck is

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

sed to drag the load onto the truck by gripping (one of) the pull tab(s). The push-pull attachment has very flat ground-level forks that are designed to go under the slip sheet whilst it is under load

3. To unload, the forklift truck pushes the load, complete with slip sheet of

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

f of itself and withdraws

Pros and Cons

Slip sheets are not the panacea to all distribution needs. For one thing, all parties in any supply chain will need to invest in the push-pull attachments, which are not cheap. The staff training that will be required, especiall

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

y for forklift truck operators, can also be expensive. Perhaps the greatest factor, though, is the uniformity of the load itself. This exposes the slip sheet's greatest advantage - and greatest disadvantage. Slip sheets may not be able to cope when boxes are awkwardly shaped or w

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

here there is a mixed load of different shapes. Conversely, if a company is shipping out large quantities of the same sized box, then slip sheets are ideal. As such, slip sheets lend themselves to operations further upstream of the supply chain. As loads are broken down further do

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

wnstream, then pallets may be more appropriate. The good thing is that loads of slip sheets can be easily transferred to pallets. A good example of the advantages of using slip sheets is where parts for goods are manufactured and shipped through a long distance sea route. The spac

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

and weight saving can result in a significant financial boost for the value chain.

Co-operative Value Chains

Another great factor in all this is uniformity of slip sheet systems. All parties in the supply chain need to be using the same specification of slip sheet and en

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

sure that all staff are fully trained to ensure delivered loads are configured correctly for the receiving party. This requires value chains that are highly co-operative, or, to be realistic, it requires a value chain that has one dominant party who will simply dictate their requi

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

rements. The U.S. has pioneered slip sheets and has used them for many years. However, the dominance of the supermarket sector in some European countries may be forcing the change there also. The ability of large supermarkets to influence their supply chains means that they are in

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

a position to take a strategic view of the benefits that slip sheets can bring. They are in a position to arrange for both senders and receivers to be ready to handle products on slip sheets. Things are changing. Perhaps the pallet industry is about to get a jolt.

Watch this spa

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ce. There are tremendous savings to be made and significant environmental benefits to be gained. Full conversion to slip sheets for any supply chain is not going to happen, but a partial conversion for particular product lines is not only desirable, but inevitable - even in Europe

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Unless companies adopt an holistic approach to security that focuses on building and fostering a culture of honesty and integrity, GAP's will appear in their defenses and in their ability to perform their mission; selling their products and services. Once GAP's are exposed, they can be exploited for the personal gain of the individual(s) exposing them.

Practical advice for Australian businesses seeking to understand some of the cultural differences between American and Australian business practices. Information presented here is based on extracts from a free guide authored by the Australian Trade Commission for Australian businesses seeking to enter the US market and based on the observations and experiences of the Commission's Senior Trade Commissioner in Los Angeles, Kylie Hargreaves.

Tips on preparing to sit for the PMP Exam. Choosing PMP Exam Prep Providers. About the PMP Certification.

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