Advice You - Business

Many big or small organizations had jump into the band wagon to look for a success formula for their business success. The Total Quality Management (TQM) is one of those formula. Though it has been a chal

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

lenge to implement TQM, there are many success stories. What are some of the Critical Success Factors in implementing TQM?

Total Quality Management concepts is not new in the manufacturing industries. 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 of them has witnessed successful organizations are also TQM organizations. If TQM can make an organization successful, who is it not all organizations adopting to the implementation of TQM?In this TQM

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

rticle, I am delighted to share my experience acquired from companies that I have worked with as a consultant/Facilitator as well as implementer.

For a big organization such as Multi Nat

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

ional Corporation (MNC), Electronic Original Equipment Manufacturer (OEM), there is a Vision and Mission Statement displayed prominently in pertinent locations. There is a systematic documentation system

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

Combination pro

that provides policies and procedure in their operations. For many of them, besides been certified in ISO18000, ISO14000 and ISO9001, they have obtained several product certification such as CE Marking, U

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

L, etc Due to these initiatives and its requirement for its maintenance, a systematic continuous improvement approach has to be in placed and evident throughout the organization in order to fulfill certif

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

ication requirements. Many of them adopted improvement methodology such as 6-sigma, lean manufacturing, TPM etc. Besides, all of these systems, organizations are very much customer driven.While some of

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

hem adopted the TQM in full version (according to the TQM guru's), some has their own version of TQM as they often employee internal expertise.

For medium organizations, many of them ha

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

s their Vision and Mission established too. And almost all of them are ISO9001 certified. On top of the Quality Policy, documentation system is in placed. For some, addition management system such as ISO1

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

000 and ISO18000. They are fairly active in the compliance to these ISO system. Improvement initiatives are scattered across the organizations and to some extend, ad-hoc problem solving approach is been

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

Following aspects would a

practiced. A Quality personnel is often assigned to maintain these systems and he is expected to drive it.

For small organization, many of them are ISO9001 certified hence has adopted a

dd to the challenges in developing combination products:

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

basic documentation system. There is a a minimum Quality Policy established due to the requirement by ISO9001. Basis documentation system is in place, compliance to the ISO documentation is often last mi

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

ute effort. Adoption to systematic improvement methodology seems to be rare. Fire-fighting approach to solve problem seems to be a formula for continuous improvement. TQM is not an approach to be consid

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

ered as it meant more manpower is needed. In many cases, production personnel is assigned to maintain these systems.

In summary: The adoption of the Total Quality Management system lies

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

with the leadership in the organization. The variation in adopting TQM as a way to run business depends very much on the scale of the organization, leadership and urgency.

-------------------------------

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

Professional from academic institutions, pharmaceutical industries, health care indust

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

of terminology are his 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.

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.

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

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

Companies that provide selfless information through particip

x 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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