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Measurement of actual performance does not only mean knowing what has happened, but also what is likely to ha

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

ppen. It means that deviations are predicted in advance, which helps the management to take corrective action

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

Examples of combination products may in

in advance for the achievement of goals. As such, it is desirable to measure performance as soon as the oper

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

ations are completed. Not only this, it can also be measured while the activity is in progress, so that appra

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

isal would be possible in time.

Measurement of performance can be done by personal observation, as in the ca

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

Combination pro

se of subordinates being observed while they are engaged in work, and by a study of various summaries of figu

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

res, reports, charts and statements. If the control system is well organized, quick comparison of these figur

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

es with the standard figures is quite possible. This will reveal variations. Some variations are desirable, s

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

uch as the output above the standard or expenses below the standard. But some other variations are undesirabl

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

e, such as a variation in the delivery schedule agreed upon with customer or a variation in the speed limit f

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

ixed for all drivers.

One important point to be considered before introducing a control system is whether me

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

Following aspects would a

asurement and comparison are to be done at various stages in the total process, or at the end. If the purpose

dd to the challenges in developing combination products:

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

of control is to troubleshoot while trouble is forming, then observation should be done at various strategic

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

points as work progresses.

The actual performance can be easily compared if the standards are properly dete

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

rmined and methods are clearly communicated. The manager should concentrate on those main deviations, which a

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

re noticed while making the appraisal. But he/ she should not waste his time and energy on small deviations.

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

Professional from academic institutions, pharmaceutical industries, health care indust

This approach will give the correct, quick and favorable results. At the same time, simple and effective acti

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

on also avoids uneconomic watching, wastages of time and attention.

While comparing the actual and standard

.

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

performance, it is wiser to find out the extent, nature and basic causes for deviations. A competent manager

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

Companies that provide selfless information through particip

does not find any difficulty in locating the deviation points while measuring the actual performance properly

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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