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Subjects - Lean Manufacturing Quality Concept And Traditional Quality Concept – A Comparison
Have you ever thought “quality products are expensive”? You might be prepared to pay some e
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
xtra money for a high quality product. I believe you have taken the correct move. It is alw
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ys better to buy a better quality product or service than a low quality one. But I have a s
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
all problem regarding your concept about higher price you are paying. Why you should pay ex
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ra money to get good quality product. Strange question isn’t it? But I believe it is very m
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ch a valid question. I do not believe that you have to pay extra money for the quality. I w
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
ll explain why.
There are two types of manufacturers around. One is quality manufacturers.
There are two types of manufacturers around. One is quality manufacturers.
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
They produce quality products and services. Lean manufacturers are naturally quality manufa
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
turers. The other type is average manufacturers. They produce average quality products. The
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
pick best from these products. These selected products are high in quality of cause. Then
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
hey sell these products as high quality products. Remember these are not quality manufactur
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
rs. They are quality pickers.
When your manufacturer is a quality manufacturer, you will b
When your manufacturer is a quality manufacturer, you will b
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
paying only for the products you are buying. It is obvious isn’t it? You will pay only for
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
the products that you buy. But when you buy a product manufactured by a quality picker, yo
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
are paying for the other low quality products as well. Have you thought before? You are ac
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
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
ually paying for the product you are buying, and you are also paying for the products which
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
are removed in selecting best quality products from the bunch of average quality products.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
he cost of low quality products are added to the high quality product. That is why most of
.
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
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
he manufacturers will say “High quality products are costly”. If this is a lean manufacture
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
he will say “Cost is free” instead.
You can read the first part of this article on my blo
You can read the first part of this article on my blo
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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