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Lean manufacturing refers to the ways of eliminating waste from the manufacturing process of any product. Lean

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

manufacturing increases the quality of the product including the profit levels and helps in reducing production

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

Examples of combination products may in

costs. A lower lead and set up time, low equipment costs and better position in the market can also be counted

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

as the additional advantages of the Lean Manufacturing System. However, to implement a proper lean manufacturi

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

ng system some basic principles are required to be followed or implemented.

One of the most important principl

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

Combination pro

s may be to produce a product without defects, where each part of the product is examined after manufacturing.

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

In this way, any defects detected can be corrected or eliminated at the earliest possible stage instead of reac

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

hing to the final stage and going over the whole process from the beginning. The final product can therefore be

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

kept perfect and flawless. Avoiding all activities and materials that do not add value to the final product is

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

also very important, which in turn requires to be replaced by the optimum use of valuable resources such as ma

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

power, capital and land.

Giving value and importance to the workers and all the people involved in the product

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

Following aspects would a

ion can also make a lot of difference. Workers are the people who are closest to the product and thus, their op

dd to the challenges in developing combination products:

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

inions and decisions regarding the betterment of the product can add a lot of value to it. Hence, their inputs

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

need to be valued and considered as important and necessary. Manufacturers also need to be constantly improving

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

themselves and remain flexible in their production depending on the market demands. Maintaining a healthy rela

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

ionship with the suppliers can help in analyzing market rates, demands and risks involved and in the process re

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

Professional from academic institutions, pharmaceutical industries, health care indust

sult in more productive outcomes.

Implementing and regular following of these principles would lead to a flawl

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

ess product that would automatically attract consumers and gain their preference. The best products are conside

.

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

red to be those, which are pulled by the consumer end and not pushed from the production end. The principles of

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

Companies that provide selfless information through particip

lean manufacturing are designed to meet this criterion containing the secrets of a successful production cycle

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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