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Lean Manufacturing is a strategy followed by various industries to ensure a low cost manufacturing sys

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

tem to generate the maximum output. The strategy was first implemented by Henry ford, the owner of the

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

Examples of combination products may in

Ford Motor Company, which made a huge impact on the American Manufacturing Industry. Since its implem

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

entation the focus of the industrialists have been on optimizing the quality and the profit levels min

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

mizing the production costs.

Often, the waste of material, labor, time and effort can cause striking

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

Combination pro

differences in productivity, affecting the overall cycle from the production factory to the shop floor

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

. Lean manufacturing ensures methods and ways of producing results that can improve and change this sc

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

nario.

The Toyota Production System, also similar to lean manufacturing, came up to increase the prod

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

uctivity by centralizing the stockpiles, known as kanban, around the assembly line, lowering waste and

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

enhancing productivity on the production floor. They also put efforts into building and maintaining a

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

good partnership with the suppliers to keep the flow of the production cycle going.

According to this

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

Following aspects would a

concept, importance should be given to attain perfection while delivering the final product and all u

dd to the challenges in developing combination products:

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

n-necessary activities are required to be eliminated. Also, the use of scarce resources comprising of

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

capital, workers, and land should be utilized to their most in order to ensure its success.

Lean manu

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

acturing helps in saving millions of dollars and provide a better position in the competitive market.

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

Both Lean Manufacturing and the Toyota Production System believe in attaching value to the workers and

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

Professional from academic institutions, pharmaceutical industries, health care indust

empowering them to take important decisions regarding the progress of the production. This helps in p

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

oducing a flawless product since the workers are the closest persons to the product and make a differe

.

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

nce in ensuring the quality of it. In a nutshell, lean manufacturing is all about doing all the right

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

Companies that provide selfless information through particip

things to support productivity and profitability while cutting off the unwanted waste and cost factors

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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