Advice You - Business

Industrial safety is important for all employees on a daily basis and working in an area without safety awareness may result in serious bodily harm or possi

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

bly even death. Industrial safety is a key factor in running a company and there are many aspects to consider when providing overall safety for your employe

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

Examples of combination products may in

s. You must ensure that employees have special equipment and procedures to ensure eye safety, ear safety, head protection, fire prevention and respiratory p

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

otection. Here are ways to ensure you (or your employees) are protected in each of these areas.

Eye Safety - Any injury to the eye can be very serious and

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

ossibly cause permanent eye damage to the victim. It is important to make sure your eyes are covered at all times by wearing goggles or other forms of eyewe

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

Combination pro

ar. Make sure the goggles you are wearing provide protection around the sides of your eyes as well, otherwise flying debris may come in through the side and

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

puncture your eye.

Ear Safety - Ear safety is important because without it, our ear drums would be severely damaged from the loud noises constantly occurri

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

g in the workplace. Ear plugs and ear muffs are the most common forms of ear protection, however there are other alternatives as well, such as disposable he

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

ring bands. By wearing these pieces of equipment, you are not only protecting yourself from loud noises, but also from flying debris which may enter the ear

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

and possibly cause infection.

Head Protection - Protecting your head is easy and can end up saving you a lot of pain if an unwanted situation does occur.

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

earing protective head gear can be as simple as putting on a helmet or hard hat before entering a location where there may be falling objects. Head injuries

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

Following aspects would a

may result in brain damage, but you can significantly decrease the chance of serious injury by wearing head protection.

Fire Prevention - Working in an ind

dd to the challenges in developing combination products:

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

strial area means that there is always a possibility that a fire may occur. If a situation like this arises, you will want to be prepared and the best way t

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

o do so is by having a fire extinguisher on hand at all tomes. Fire extinguishers are the best way to eliminate or control fires until the fire department a

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

rives.

Respiratory Protection - Working in an area in which the air is constantly filled with pollutants can be dangerous and may ultimately result in seri

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

us respiratory problems for individuals working in these areas. A simple way to protect yourself from poor air quality is to wear a respiratory mask when wo

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

Professional from academic institutions, pharmaceutical industries, health care indust

king in these areas. Wearing a face mask can greatly decrease your chances of suffering from respiratory problems in the future.

Other Safety Wear - Other

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

forms of safety wear which are critical in industrial areas include work boots and gloves. These are important in areas which you will have hands-on contact

.

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

with dangerous equipment or areas where you may possibly drop the equipment onto your feet.

It is important to research and follow all safety rules when wo

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

Companies that provide selfless information through particip

king in an industrial area. Everything can change in a split second and you want to ensure you are as prepared as possible for any situation which may arise

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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