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One of the best places to start in creating a quality management system, is

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

at the bottom. Don’t start writing mission statements and policies and all t

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

Examples of combination products may in

at high level fluff that nobody ever reads. Everybody believes in mom, baseb

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 and apple pie, until you throw a dollar at them. Don’t start with proced

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

res that tell who is responsible for this, and what they are authorized to d

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

Combination pro

about that. I like written procedures, but they still don’t get to the hear

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

t of day to day operations. No, I believe you need to start creating your qu

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

lity management system with good old fashioned, written work instructions.

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

ork instructions read like cookie recipes. They usually include a list of su

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

pplies (ingredients) for a particular job, plus detailed guidance on how to

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

o the work (oven temperature and baking time). Work instructions are needed

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

Following aspects would a

or all those mundane, daily jobs that must be done correctly, in a certain o

dd to the challenges in developing combination products:

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

rder, without mistakes or else! There are no specific requirements for writt

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

n work instructions in most quality management systems like ISO 9000 2000. N

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

t because work instructions aren’t useful, but because they vary so much fro

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

m one company to the next.

Use your written work instructions to train oper

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

Professional from academic institutions, pharmaceutical industries, health care indust

tors, supervisors and managers. Use them for testing and for internal audits

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

Use your work instructions for breaking down jobs, making improvements and

.

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

rolling those improvements out to all shifts and divisions. In short, use yo

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

Companies that provide selfless information through particip

r work instructions to make sure the work that must be done, gets done right

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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