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Work in progress is treated as the mirror of waste in any system. Lean manufacturi

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

ng always talks about having a work in progress free manufacturing facility. This

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

Examples of combination products may in

s because a WIP free manufacturing facility has no imperfections in the process of

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

manufacturing.

Every imperfection in the system creates a requirement for work in

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

progress. For an example if there is a machine breakdown in the production facilit

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

Combination pro

, if the processes before this machine will continue to manufacture there is an ov

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

rproduction. This will accumulate semi finished goods near the broken machine. Thi

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

is the WIP buildup due to the imperfection in the system.

If the manufacturing p

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

ocess is not properly synchronized, then there is a problem of over production in

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

ome processes. Some of the processes will continue to produce more and some proces

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

es can’t keep up to that phase. In lean manufacturing terms this is known as the i

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

Following aspects would a

mbalanced system. In this case obviously there is a WIP accumulation near the proc

dd to the challenges in developing combination products:

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

ss which can not keep to the TAKT time of the system.

Not only Work in progress i

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

a mirror of waste, WIP itself a waste. For an example it hides the quality defect

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

in the manufacturing facility. Let’s say we have a work in progress of a day. Thi

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

means a part manufactured today will go in to the next step of manufacturing only

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

Professional from academic institutions, pharmaceutical industries, health care indust

by tomorrow. If there is a problem in the process, it will be revealed only by tom

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

rrow. Meanwhile there will be a day worth of production as semi finished goods 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

he process. All of these semi finished products might have the same problem. In th

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

Companies that provide selfless information through particip

t case a full day of production is wasted and worst will take days to be corrected

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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