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Statistics are at the heart of Six Sigma’s powerful methodology for quality improvement. It pays to get to know some of the most important of the Six Sig

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

ma statistical tools.

Control Charts

The control chart is the fundamental tool of statistical process control; a proven technique for improving product

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

Examples of combination products may in

vity. It monitors the variation of key characteristics and indicates the range of variability that is built into a system. Control charts provide diagnos

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

ic information about process capability that can be used to analyze variation in process data to demonstrate whether a process is operating consistently.

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

The bounds of the control chart are marked by upper and lower control limits that are calculated by applying statistical formulas to data from the proces

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

Combination pro

. Data points that fall outside these bounds represent variations due to irregular causes, which can then be identified and eliminated. Control charts ar

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

effective in defect prevention and will help ensure that your process performs consistently. From them, you can, in a precise manner, monitor, control,

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

nd improve on process performance over time. This will allow you to be able to predict fluctuations, lower costs and ensure the process has a higher effe

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

tive capacity.

Failure Modes and Effects Analysis (FMEA)

FMEA is a powerful structured approach that helps you to identify and counter weak points in t

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 early conception phase of products and processes. Using FMEA allows you to analyze any system or subsystem in manufacturing or service industries in th

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

early stages of the process. This systematic methodology identifies potential failure modes in a system caused by either design or process deficiencies.

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

Following aspects would a

It also identifies critical or significant design or process characteristics that require special controls to prevent or detect failure modes. FMEA impr

dd to the challenges in developing combination products:

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

ves the quality of products and services and processes by preventing problems from occurring. It documents and tracks action taken to reduce risk while i

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

integrates with the DMAIC methodology.

Histogram

A histogram is used to graphically summarize the distribution of a data set. A histogram is construct

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

d by dividing the range of data into equally sized segments. This data tool enables you to quickly and easily answer several important questions: what di

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

tribution does the data have? What is the most common system response? Is the data symmetric or does it contain outliers?

Pareto Chart

A pareto chart i

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

Professional from academic institutions, pharmaceutical industries, health care indust

used to graphically summarize the relative importance of the differences between groups of data. A pareto chart is constructed by dividing the range of

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

ata into groups. The vertical axis of the pareto chart is the cumulative percentage, and the horizontal axis of the pareto chart is the groups of respons

.

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

variables. Unlike the histogram, the pareto chart is ordered in descending frequency magnitude. The Pareto Chart allows you to focus your efforts to ach

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

Companies that provide selfless information through particip

eve the greatest improvements by identifying the largest issues facing the process. It identifies the 20% of sources that are causing 80% of the problems

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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In the previous article, the author dealt with Part 10 of the Baldrige Values and Concepts – Managing for Innovation. This Part 11 issue will share his research on Systems Perspective: one of the Eleven Values and Concepts of Malcolm Baldrige Criteria. He compared the direction set by the CEO of the researched companies and CEO of Baldirge winners.

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