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Lean manufacturing fundamentally aims to reduce waste and make companies more competitive by helping them turn into flexible firms which are open and

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

subject to positive developments, innovations and changes.

To put it simply, lean manufacturing espouses the 'no waste' philosophy in managing 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

orkplace and production processes. It does not know any company size, whether it's a major corporation or a small group of five housewives with a coo

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

ie business.

Due to this objective, the lean manufacturing principles function as the guideline for companies wanting to get the best out of their o

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

ganization. The lean manufacturing principles are taken as the outline for making a more productive working environment.

The key of lean manufacturi

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

Combination pro

g principles can be identified as:

Getting it right the first time with no defects

Identify and tackle the problems right at the source i

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

stead of wasting time during quality inspection at the end of production process. The key here is to reach the maximum efficiency by rectifying the

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

identified problem right from the beginning before it becomes a major problem.

Non-value added elimination and optimizing all resources

Better

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

se of the resources by eliminating any insignificant activities, people or departments. Identify their talent and capabilities. Then reassign them to

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

other sector where the company can utilize and get the best out of their talent.

KAIZEN or Continuous Improvement.

The focus here is to continu

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

usly improve and keep raising the bar of performance and excellence in the business. Examine any possibilities of reducing costs, improving the qual

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

Following aspects would a

ty and increasing the productivity. A better information sharing, streamlined operations and great teamwork is essential to keep KAIZEN live.

dd to the challenges in developing combination products:

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

tomer -demand drives in a pull not push system.

Instead of pushing at the beginning of the production line, the products are driven by the demand fr

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

m the customer. With this principles, the cost of inventory and wait times can be reduced and even eliminated where possible.

Flexibility and Ad

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

aptability

Always monitor the market and demand trend. The management should develop a practical business plan which can be flexibly adjustable to s

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

dden increase in demand without compromise the quality of the end product.

Relationship

The final key of lean manufacturing principles is to ex

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

Professional from academic institutions, pharmaceutical industries, health care indust

ent these efficiencies and efforts to the supply chain and other business partnerships. Side by side, both, the supplier and the company will create

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

n efficient system by building relationships that fit, work and last.

Of course, adopting lean manufacturing principles does not always

.

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

mean a leaner, more productive organization. It still takes careful planning, method-mapping and a lot of discipline to succeed. If the company is no

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

Companies that provide selfless information through particip

wary of the consequences of strategies that are haphazardly implemented, then these lean manufacturing principles will be in vain -- and total waste

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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