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ISO 9000 grew out of BS 5750, a standard published by the British Standards Institution (BSI) in

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

1979. Initially, it was used only in manufacturing industries. ISO 9000 is now employed across

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

Examples of combination products may in

variety of other types of businesses. It is a set of international standards of quality managem

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

ent systems. ISO 9000 has been accepted by more than 100 countries as their national quality ass

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

rance standard by the end of 1997.

The history of ISO 9000 dates back to Mil-Q-9858a, the first

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

Combination pro

quality standard for military procurement established in 1959 by the US. By 1962, NASA (Nationa

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

Aeronautics and Space Administration) developed its quality system requirements for suppliers.

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

In 1965, NATO (North Atlantic Treaty Organization) accepted the AQAP (allied quality assurance p

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

ocedures) specifications for the procurement of equipments.

During the 1970s, BSI published BS

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

9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance

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

norms. In 1979, it created BS 5750, a series of standards for use by manufacturing companies. T

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

Following aspects would a

ey were enforced through assessments and audits. In 1988, ISO (International Standards Organizat

dd to the challenges in developing combination products:

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

ion) adopted the BS 5750 standard without changes and published it globally under the name ISO 9

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

00. The ISO adopted this standard with a view to create an international definition of the neces

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

sary characteristics of a quality system for all businesses, regardless of industry. In 1994, th

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

ISO revised the ISO 9000 standard and published it globally.

In the beginning, ISO 9000 was im

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

Professional from academic institutions, pharmaceutical industries, health care indust

plemented exclusively by large companies. But by mid-1990s, small and mid-sized companies began

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

o increasingly implement these standards. In the United States, the total number of registration

.

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

s increased from a little more than 2,200 in 1993 to more than 17,000 in 1998. Of these 17,000 r

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

Companies that provide selfless information through particip

gistrations, almost 60 percent were held by businesses with annual sales of $100 million or less

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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Advice Pool - History of ISO 9000

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