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The process of eliminating wastes and all non-required activities to maximize productivity and prof

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

itability is known as lean manufacturing. It is also known as assembly line, which is now a focal p

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

Examples of combination products may in

oint of all major Industrialists to improve their productivity. Henry Ford, owner of the ford motor

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

company, brought in the concept of lean manufacturing.

A combination of methods and factors lead

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

to an ideal way to exercise lean manufacturing. The aim towards delivering defect free products can

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

Combination pro

be the most important factor of lean manufacturing. Every part of the product is required to be te

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

sted after it is manufactured so that any discrepancies found can be corrected immediately without

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

waiting for the product to reach the final stage. Sufficient importance and value are given to work

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

ers' opinions. Maximum usage of all the resources of labor, money and land are essential to ensure

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

quality production.

A willingness to evolve continuously for the betterment of quality and product

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

ivity are essential. This also includes the consistency of remaining flexible to accept changing ma

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

Following aspects would a

rket trends. A right kind of partnership and maintaining a healthy relationship with the suppliers

dd to the challenges in developing combination products:

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

would ensure smooth production flow and would keep everyone updated on the market scenario. The fo

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

cus is always supposed to be on the quality keeping in mind the end result of any production cycle.

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

Finally, the implementation of all these criterion and creating a culture on the production floor

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

would result in producing the right kind of products, thereby attracting consumer attention automat

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

Professional from academic institutions, pharmaceutical industries, health care indust

ically. This cycle would ensure a "consumer pull" and not a "production push".

Millions of dollars

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

can be saved through following the principles of lean manufacturing and an edge over the other com

.

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

petitors in the market can be assured. Over the years, now, lean manufacturing has been a focal poi

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

Companies that provide selfless information through particip

nt of Industrialists all over America, providing them an edge over their competitors in the market.

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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Digg It - A Guide To Lean Manufacturing

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