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In this issue, I will share my experience acquired from the conglomerate and its operating companies. For the purpose of this article, I will articulate the Public Responsibility and Citizenship which is one of the Eleven

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

Values and Concepts in Malcolm Baldrige Criteria. As before, I will use case studies to show how some of the companies implement them.

To recap, below are the Eleven Core Values and Concepts of Baldrige Criteria:-

Visio

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

Examples of combination products may in

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

nship | Focus on Results and Creating Value | Systems Perspective

I will deal with the one of the Value in bold letters in this article as below:-

Articulated Public Responsibility and Citizenship

An organization’s lea

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

ers should stress responsibilities to the public, ethical behavior, and the need to practice good citizenship.

Leaders should be role models for your organization in demonstrating the practice of business ethics and public health, s

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

Combination pro

afety, and the environment. New product planning should include anticipation of adverse impacts from production, distribution, transportation, use, and disposal of your products. Hence, an effective planning to prevent it

Leaders

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

of organizations should stress to not merely comply to the local and export law and regulatory requirements, but they should treat these and related requirements as opportunities for improvement “beyond mere compliance”. All these s

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

ould be demonstrated by appropriate measures and target.

Case Study on Public Responsibility and Citizenship

In most of the companies I work with, minimum emphasis is put in placed to address these issues. Most of the time

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

, it is reactive to problem pertaining to it. While most companies attempted to comply to the legal and regulatory requirements, non has a plan to exceed the requirement to it advantage. At times, compliance are done only when autho

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

rity come along for inspection.

On the other hand, all companies complied to the export environmental requirement due to the stringent export controls. As this has a direct impact to the sales revenue, there is no incidence organiza

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

ion is ignoring the export safety, health and environmental requirements.

Opportunity for Improvement

I came across an electronic company in the United States has taken one environmental issue as a strategic issue. This comp

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

Following aspects would a

any has a structure program to reduced the energy consumption in order to reduced its fuel usage. Not only it reduces impact to the environment, it also brings about cost saving in term of reduction in energy usage. It has done to a

dd to the challenges in developing combination products:

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

n extent that it save the organization several million dollars in terms of operation expenses.

Companies should take this example as look critically its operation. As most of the waste come from the operations, perhaps look hard eno

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

ugh to the operation and focus on how to reduce the waste into the waste treatment plan. By doing so, it will certainly reduce the waste hence reduce the material cost.

In summary, having understood the Public Responsibility an

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

Citizenship in Values and Concepts of Malcolm Baldrige, it should be taken as a strategic issue rather an operational. Most companies have in placed a Marketing Strategy, some would have Operational Strategy, would you want to

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

consider having HR Strategy too? Leaders might benchmark their CEO of Baldrige Winners on their TQM successes in this value. My next article will articulate the next Core Values and Concepts in Focus on Results and Creating Value

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

Professional from academic institutions, pharmaceutical industries, health care indust

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Disclaimer: This article is written by the author based on his practical application experience. All definitions and interpretation of terminology are h

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

s point of view and has it has no intention to conflict with experts in similar topic. The author holds no responsibility for the use of this article in any way. Full Baldrige Criteria are available at .

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

ww.nist.gov/quality">http://www.nist.gov/quality

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Free to reprint or re-publish: All rights reserved. You are free to reprint or re-publish this article a

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

Companies that provide selfless information through particip

s long as you include my resource box at the end of this article. And ensure that the URL in the resource box remained intact and it is linked to the author's website.

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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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