Summary - Reference and Education

ISO is the International Organization for Standardization which was established in 1947 and it's head office is located in Switzerland.The members of ISO came from over 1

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

20 national standards bodies. The word ISO was taken from ISOS which means Similar.

What is ISO 9000:2000?

•ISO 9000 is a family of ISO standards for quality man

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

Examples of combination products may in

gement systems.
•ISO 9000 was developed from the British Standards Institution's BS 5750.
•The ISO 9000 2000 Standards apply to all kinds of organizations in al

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

l kinds of areas.

Revisions

•The standard has evolved over several revisions.
•The initial 1987 version, ISO 9000:1987
•The 1994 version, ISO 9000:1994

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

br> •The 2000 version, ISO 9000:2000

ISO 9000 Document suite
•ISO 9000:2000 Quality management system s - Fundamentals and vocabulary.
•ISO 9001

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

Combination pro

Quality management systems - Requirements
•ISO 9004 Quality management systems - Guidelines for performance improvements.

Benefits of ISO 9000:2000

•I

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

proved customer satisfaction
•Improved productivity and quality
•Transparency of process
•Increase the competitive power
•Brings commitment of the top

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

management

ISO 9001: 2000 QMS Requirements

•ISO 9001 applies to all types of organizations. It doesn't matter what size they are or what they do. It can h

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

lp both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.
•ISO 9001 2000 has replaced 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

he old ISO 9001 1994 standard. In addition, the old ISO 9002 1994 and ISO 9003 1994 quality standards have been discontinued. They are now obsolete.
•This is the act

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

al standard we need to use if we wish to become certified.

Contents of ISO 90001: 2000

ISO 9000 seeks to set criteria which achieve a goal and is not prescri

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

Following aspects would a

ptive as to methods.
• The requirements come in Sections 4 to 8.
•Section 4 is entitled General Requirements
•Section 5 is entitled Management Responsibi

dd to the challenges in developing combination products:

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

ity
•Section 6 is entitled Resource Management
•Section 7 is entitled Product Realization
•Section 8 is entitled Measurement, analysis and improvement <

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

br>

In the standard, there are 6 documents that ISO specifies:
•Control of Documents (4.2.3)
•Control of Records (4.2.4)
•Internal Audits (8.2.2)

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

Control of Nonconforming Product / Service (8.3)
•Corrective Action (8.5.2)
•Preventive Action (8.5.3)

In addition to these, ISO 9001:2000 requires a Qu

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

ality Policy and Quality Manual (which may or may not include the above documents).

8 management principles of ISO 9001: 2000

1.Customer Focus
2.Leadership<

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

Professional from academic institutions, pharmaceutical industries, health care indust

r> 3.Involvement of People
4.Process Approach
5.System Approach to Management
6.Continuous Improvement
7.Factual Approach to Decision Making
8.M

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

utually Beneficial Supplier Relationship

QMS Documentation Structure

Level 1: Quality Manual
Level 2: Quality Procedures
Level 3: Work Instruction

.

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

Process sheets

Inspection Standard

Control Plans

Drawing / Specification
Level 4: Records

Although ISO describes a lot and suggests to do

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

Companies that provide selfless information through particip

a lot of things it is not a SILVER BULLET. It just shows the way. ISO is silent on teh aspect as to HOW the things have to be doen it only specifies WHAT needs to be done

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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