Useful Advices - Business

Establishing and maintaining clear written policies and procedures is one of the key factor i

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

s having a successful business. Even if you have just one employee, you need written procedur

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

Examples of combination products may in

es to prevent mistakes.

Most people it seems would rather eat dirt than sit down and write a

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

policy and procedure manual, but when you understand the benefits of having one, you will re

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

alize it is worth the effort. Also, eating dirt may be good for you according to the sea salt

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

Combination pro

advocates.

Some of the Benefits of written procedures:

Having written procedures prevent m

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

istakes
Having written procedures frees your creativity
Having written procedures

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

saves time
Having written procedures ensures consistency and improves quality
Havin

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

g written procedures will free you from worry about your employee's decisions

The more detai

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

led the procedure the better. Instead of telling employees things not to do and inspiring a n

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

gative emotional environment, tell them exactly what you expect them to do and when. If they

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

Following aspects would a

know exactly what to do and how to do it then the other stuff will often take care of itself.

dd to the challenges in developing combination products:

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

Let's that a dress code for example. Instead of making a long list of things people can't w

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

ear, make a policy that describes acceptable dress. Be as detailed as possible about the kind

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

of image you want your employee to portray and why it is important that they portray that im

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

age. Allow some freedom of expression and you employees with be happy to comply.

Having clea

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

Professional from academic institutions, pharmaceutical industries, health care indust

r written procedure will also help you in the case there is ever any disagreement. You simple

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

point to the written procedure and make sure that it is consistently applied. If you allow e

.

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

xceptions to the policies write them down as well.

But generally having clear, detailed writ

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

Companies that provide selfless information through particip

ten procedure and policies will avoid many workplace communication problems before they begin

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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Useful Advices - Policies and Procedures are Important

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