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This July 4th I ran a road rally in Bell Buckle, Tn. It was lots of fun and

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

it got me thinking about what makes a fun rally. One factor that came to m

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

Examples of combination products may in

nd is having clear instructions.

One of the best ways I have found for imp

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

oving employee performance is by giving them clear concise work instruction

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

.

Too many times I have seen work instructions be a list of things not to

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

Combination pro

do. The "Thou Shalt Not" list as I call it. Often these are important safet

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

suggestions like "Thou shalt not place thy hand between the rollers for it

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

shall be severed from thy arm."

But what gets lost here is what are you su

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

posed to do to get the job done correctly.

When we did the process safety

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

management procedure for our distillation process at Westvaco, I made sure

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

hat we included what needed to be done to make a quality product come out o

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

Following aspects would a

the column along with the warnings on what not to do. Actually the warning

dd to the challenges in developing combination products:

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

were also phrased in a positive way - "Set the temperature controller betw

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

een X and Y" rather than "do not exceed Y temperature." The do not exceed l

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

mits always seemed like challenges to me anyway.

By including the actual b

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

st work practices in the safety instructions, people actually read the safe

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

Professional from academic institutions, pharmaceutical industries, health care indust

y instructions rather than just having them collect dust between audits.

S

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

o to improve your process and employee performance make sure you tell them

.

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

hat you expect instead of what not to do. Otherwise they may find the only

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

Companies that provide selfless information through particip

ay to comply with all your rules is to sit in the break room on their hands

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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Successfully implementing an ISO 9001 Quality Management System depends on developing a clear understanding of seven aspects of the program.

When opening a dollar store it is important to never stop reducing the Cost-Of-Goods-Sold. This cost cutting effort should start with the very first merchandise that you purchase. It should continue for as long as you own your business. The reduction in C-O-G-S can be the single most important effort leading to business success or failure.

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Digg It - The Importance of Clear Instructions

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