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Six Sigma has become a buzzword in industry circles since its introduction in the 1990's. The methodology is based on a disciplined and data driven approach and is used for eliminating defects

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

and achieving near perfection by restricting the number of possible defects to less than 3.4 defects per million. It is being used effectively for managing processes of both, manufacturing an

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

Examples of combination products may in

d services industry. In the manufacturing industry, it is used for limiting defects in the goods produced whereas in the services sector it is used mainly for reducing transactional errors.

W

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

at Is Process Simulation And Modeling?

Simulation software based on Six Sigma methodologies can be used for simulating a wide range of processes in order to eliminate common industry problems

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

related to defects, wastage of productive resources, and quality control. The basic idea governing Six Sigma process simulation is to provide an accurate system of measuring defects in a proc

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

Combination pro

ss, so that these can be eliminated during the actual production. The emphasis is on measurement and statistics for ensuring that the process is properly set up and measured. The methodology 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

s also used for measuring baseline performance, which helps predict the effects of any improvements made in the process. Proper application of Six Sigma methodologies leads to tangible improve

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

ents effected by decisions that have been explored and proven in detail.

Scope

The Six Sigma philosophy covers different aspects of industrial processes ranging from pure defect management t

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

o process performance improvement. With the increasing use of Six Sigma methodologies, it has become widely accepted that process simulation and modeling techniques can be used for improving a

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

most any type of manufacturing or transactional process. Most of the process simulation and modeling techniques are based on DMAIC (Define, Measure, Analyze, Improve, Control). In the 'Define'

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

phase, the process simulation techniques are used for identifying the changes that would have made the most impact on the outcome. This helps in making the most appropriate changes. Various s

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

Following aspects would a

imulation tools are used throughout the other phases for providing detailed statistical data on the effect of any proposed changes related to throughput, utilization, delays, service levels, a

dd to the challenges in developing combination products:

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

d any other factors related to the process.

How The Simulation Model Works

• The simulation software coverts numerical data into graphic representations, which are relatively easier to under

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

stand.

• Commercial companies that specialize in providing Six Sigma services offer customized services, wherein the simulation model is an exact replica including all the elements used

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

n the actual process such as machines, labor, conveyor and belts.

• All these elements are represented by icons and once they are in place, one can define the link between these elements, est

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

ablish the process flow, and add as much detail as possible for simulating the actual process more accurately and more effectively.

• After setting up the simulation, one can simulate an infi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ite number of hypothetical scenarios both positive and negative that might affect the process. For example with the help of simulation, a manager can know exactly what will happen if a crucial

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

machining tool breaks down or half the labor force does not turn up for work.

• All these factors can severely affect production. However if the extent of potential damage is known beforeha

.

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

d, appropriate contingency plans can be put in place for restricting or even eliminating the possible loss of production.

Process simulation and modeling techniques help executives make infor

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

Companies that provide selfless information through particip

med decisions. The data generated by the simulation tools empowers decision makers with a deep insight about the process and procedures, allowing them the ability to make the necessary changes

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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The service industry is the fastest growing industry. It becomes imperative to ensure the management of such services. There are many professional management organizations that cater to quality control requirements of an industry.

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