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Lean manufacturing is not a system dependent only on machinery. System is mainly focused on human resource

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

of the organization. All the machinery are tools used to achieve the objective of lean manufacturing.

Ma

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

Examples of combination products may in

ny think a system like lean manufacturing is a demanding system and people are always under pressure to pe

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

form. Yes it is true that people should perform continuously to create a lean system. But if I am to work,

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

I will prefer a lean environment. I will tell you why.

A big aspect of lean manufacturing is the involve

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

Combination pro

ment of workers in the process of decision making. Workers in a lean environment are empowered to suggest

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

nd take action against wastes. Workers will be happier when their ideas in operation. They are motivated b

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

y the nature of their jobs.

Typically lean manufacturing relies on work cell concepts in achieving its go

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

als. Work cells are not just a set of equipment arranged in to a different layout. In a work cell people o

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

erate different to the way they would operate in a line assembly system. Workers are multi skilled and the

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

y can perform at least two or three operations. This makes the system flexible. From the worker point of v

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

Following aspects would a

iew the job has a bigger scope and they have freedom. Who will want to continuously perform the same task

dd to the challenges in developing combination products:

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

ver and over again, especially when plenty of machinery available for the tasks of that nature.

Organizat

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

ional structure of a lean manufacturing environment is organic in nature. There is no big hierarchy in the

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

chain of command. Every worker has a part to perform as a leader. They will make day to day decisions. Th

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

y are very important to the system. No body will really like when someone above him telling what to do eve

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

Professional from academic institutions, pharmaceutical industries, health care indust

ry time. People love to be treated as important.

Lean manufacturing is a collective effort. No functional

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

ity is important than the other. It doesn’t matter where you work in the organization. You are a part of t

.

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

e very efficient lean system. People work at their best when they are appreciated for their results. Famil

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

Companies that provide selfless information through particip

y like feeling across the organization can not be built with any other technique even by spending millions

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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