Main Subject - Business

If you have been unlucky enough to have been saddled with the onerous task of achieving ISO 9001:2000 compliance for your company, this article may prove to be your big break. At the very least it will put you

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

on a minimum fuss path to ISO 9001 certification. It may very well also rescue your career, because--as you already know--as a great deal is riding on your success.

ISO, of course, stands for the Internation

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

Examples of combination products may in

al Organization of Standardization, a worldwide organization responsible for the development of many different kinds of standards. ISO 9001:2000 is the most recent version of their Quality Management System

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

Standard. It consists of a collection of documentation that describes how a company should implement their quality management system.

To achieve certification, a company must produce both a Quality Manual

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

and a Quality Procedures Manual. This is no light undertaking. These manuals must be audited by a registrar for compliancy, and renewed at the end of each 3 year period. The larger and more complex your compa

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

Combination pro

ny, the more difficult the process will be.

So why would a company chose to conform to an ISO 9001 profile? Rarely is it because it seems like a good idea. Many companies are filled with bright people who can

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

develop their own quality management system. The primary motivating force is market pressure. Your quality management system may well be up to scratch, but who is to say?

A potential customer surveying the ma

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

rketplace, and presented with two or more competing companies he might choose to do business with, needs to feel good about his final choice. If the decision comes down to who has the best quality management system i

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

n place, common sense suggests he go with the company that has gone through the ISO 9001 certification process.

In the long run, an organization that implements an ISO 9001 system is likely to discove

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

the company runs better, with improved performance and higher profitability. But for a company just getting started, such considerations are often seen as "ideals" that get short shrift as managers race to make the

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

company profitable in the shortest amount of time. It therefore takes commitment and foresight, as well as an acute understanding of market vision in order to get to the ISO 9001 finish line.

If your company

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

Following aspects would a

already has a decent quality management system in place, your main task will be to redesign the system so that it addresses all the sticking points of the ISO 9001 documentation. If your company is large, this

dd to the challenges in developing combination products:

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

may prove to be some not insignificant undertaking.

You might be tempted to hire ISO 9001 consultants. This will be expensive, and may not in fact lead to the desired result, which is a streamlined version of

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

the Quality Manual and Quality Procedures Manual that you must submit for certification.

The reason for this is that consultants never fully appreciate the scope and depth of your company, and cannot

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

be expected to share the urgency of your plight to get it right the first time. For this reason, choosing the right in-house person to head the job may be the best option for your company. Perhaps, even, that person

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

s you. If so, you definitely have your work cut out for you, particularly if you work for a company of any real size.

The benefit, and it is a big one, of having been tasked with preparation for ISO 9001 certific

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation is that your personal value to the company is going to be cemented--no, it will be cast in iron--by a successful conclusion to certification.

The trick then, is to find a way to achieve the desired result

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

WITHOUT saddling yourself with all the headaches this job can provide. If you have already peeked at the ISO 9001:2000 documentation you can be forgiven for thinking that you may have bit off more than you can

.

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

chew. Going from zero to sixty on this task can seem like a formidable proposition.

But it need not. If it seems like you are destined to begin dreaming that you personally will be taking the ISO 9001 certificati

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

Companies that provide selfless information through particip

on test, night after restless night, instead of your quality management system, take heart. Because there is a way to get a jump start on the process, and avoid so much of the hassle that you have taken on

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.mainsubjects.org.ua/article/19986/mainsubjects-ISO-9001--2000--Implement-Your-Quality-Management-System-With-Minimum-Headaches.html">ISO 9001 - 2000 -- Implement Your Quality Management System With Minimum Headaches</a>

BB link (for phorums):
[url=http://www.mainsubjects.org.ua/article/19986/mainsubjects-ISO-9001--2000--Implement-Your-Quality-Management-System-With-Minimum-Headaches.html]ISO 9001 - 2000 -- Implement Your Quality Management System With Minimum Headaches[/url]

They started out as a small, family owned retailer and gradually began to spread beyond its small town roots to towns across America. Along the way they changed the company’s name and quickly became known for offering low prices on a wide variety of items. Consumers flock to them and they are opening more stores annually in the US than any other retailer. I’m talking about Wal-Mart, right? No, Dollar General! Let’s take a closer look at another one of America’s retail success stories, the Dollar General Corporation.

When it comes to inducting new employees into your business you only get one chance. Get it wrong and you have started to sow the seeds of doubt in the mind of your new starter in the first few weeks. Get it right and it will make a huge difference to how the person settles in. Without being perfectionist, the key is to make sure that every new starter feels excited and positive that they have made the right choice in joining your business.

India is a country of vast culture and various communities as Information technology (IT) outsourcing exports of India getting a boom in business. If India would focus on multi-dimensional projects and have the motivation to grab all the outsourcing jobs.

Tags

Links

Main Subject - ISO 9001 - 2000 -- Implement Your Quality Management System With Minimum Headaches

Related Articles: