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Step 4. Record your findings.

If you have less than 5 employees then you do not need to write anything down. Although you will fi

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

nd it useful to keep a written record of what you have done.

If you have five or more employees, then you must put in writing the

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

Examples of combination products may in

significant findings of your risk assessment. This means writing down the significant hazards and your conclusions.

Examples migh

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

be something like:

Electrical installations: insulation and earthing checked and found OK.

or

Fumes from welding: local exhaus

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

ventilation provided and regularly checked.

You must also tell your employees about your findings.

Suitable and sufficient, not

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

Combination pro

perfect.

Risk assessment must be suitable and sufficient. You need to be able to show that:

a proper check was made,
you as

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

ed who might be affected (at risk),
you dealt with all the obvious significant hazards, taking into account the number of peo

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

le who could be involved,
the precautions are reasonable, and the remaining risk is low.

Keep your written record for refere

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

ce in the future. It will help you if a Health and Safety Inspector decides to pay you a visit and asks what precautions you have

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

lready taken. Or if you become involved in any legal action for civil liability.

It can also act as a reminder for you to keep an

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

eye on any particular hazards and precautions.

You should also make sure that any new employees read the documentation so that th

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

Following aspects would a

ey are aware of what is being done.

To make things easier, you could refer to other documents, such as manuals, the arrangements

dd to the challenges in developing combination products:

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

n your health and safety policy statement, company rules and regulations, working instructions, health and safety procedures, and

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

our arrangements for general fire safety.

You may already list these procedures elsewhere. You do not need to repeat all of them,

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

but it is up to you how you wish to present the documents. You could keep them seperately or combine them all into one document.

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

tep 5. Review your assessment and revise it if necessary.

Sooner or later you are going to bring in new machinery, substances or

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

Professional from academic institutions, pharmaceutical industries, health care indust

rocedures which may lead to new hazards. If there is any significant change, add this new hazard to your assessment. You do not ne

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

d to amend your assessment for every trivial change, or for each new job.

But if any change, or new job, brings in significant ne

.

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

hazards, then you should consider them in their own right and do whatever is necessary to keep the risks down.

And finally, it i

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

Companies that provide selfless information through particip

a good working practice to review your assessment from time to time, to ensure that the precautions are still working effectively

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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