Advice You - Business

ISO 9000 is a set of international standards that ensure product and service quality. In 1987, International Organi

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

zation for Standardization (ISO) created the ISO 9000 standards providing guidelines to implement and operate quali

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

Examples of combination products may in

y management systems.

The ISO revised the standards in 1994, and again reorganized the standards and published an

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

pdated version in December 2000. The revised version includes three quality standards, namely, ISO 9000:2000, ISO 9

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

01:2000, and ISO 9004:2000. The first one presents requirements, while the last two present guidelines.

ISO 9000 s

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

Combination pro

andards help businesses create in-house quality systems and monitor their existing quality systems. To develop qual

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

ity systems, businesses should first identify areas in which quality control is required. Next step is to recognize

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

what changes are to be made. After that, they should implement the standards by updating and managing their new qua

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

ity processes.

ISO 9000 certification provides several benefits that can influence almost all activities of a comp

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

ny. The advantages range from increased stature to bottom-line operational saving. Of the numerous benefits include

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

increased marketability, reduced operational expenses, better management control, improved internal communication,

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

Following aspects would a

reduction of product-liability risks, and improved customer service.

For quality management, ISO 9000 standards re

dd to the challenges in developing combination products:

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

uire a total of twenty elements (sections.) They include management responsibility, quality management system, orde

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

entry, design control, document and data control, purchasing, control of customer supplied products, product ident

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

fication and tractability, and process control.

ISO 9000 standards are generic as they can apply to any business,

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

ervice or product, regardless of the industry. Businesses that employ these standards include manufacturing, proces

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

Professional from academic institutions, pharmaceutical industries, health care indust

sing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting,

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

trucking, and banking.

ISO 9000 is of great importance owing to its worldwide orientation. It has become the logic

.

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

l selection of all organizations that do business internationally, and for customers who want an international stan

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

Companies that provide selfless information through particip

ard of quality. At present, national standards bodies from more than 120 nations support ISO 9000 quality standards

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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