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In Part 1 of this article we looked at how your employees could be brought to a level of good understanding of the hazards and how to overcome them. Part 2 looks at other aspects

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

of your role as an employer in meeting the necessary requirements connected with your ‘duty of care'.

Are you supervising your employees enough? This is not simply a matter of s

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

Examples of combination products may in

owing your face every so often, but ensuring that you meet with them regularly to discuss any issues that may be occurring concerning their work. Often, when Cleaning Companies s

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

aff out jobs, it is the cleaners themselves who know more about what is going on in the contracts than the managers themselves. Employees should be encouraged to come to you with

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

any problems they may be having with any of the techniques, equipment, language, or the client. It may be that after discussions with your cleaning staff you decide to review the

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

Combination pro

e aspects of the contract, or it may be that everything is running smoothly and no action is required. Either way, the opinions of your employees matter, and these meeting times

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

an provide a simple and effective way of dealing with problems before they begin.

It is your responsibility as an employer to provide all of your staff with the correct Personal

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

rotective Equipment. Cleaning staff are not responsible for providing their own PPE. It is essential that you make you employees aware of the reasons that they need PPE, the cor

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

ect use of such items and procedures for replacing and/or repairing items. Communication should be encouraged, and you should always respond promptly to any issues that your empl

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

yees raise concerning PPE. Items of PPE must be suitable for the task and must be a correct fit for the individual. It is your responsibility to do your research into the proper

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

ies and correct use of PPE to determine suitability, for instance, the resistance of certain gloves to particular chemicals. Because PPE is a last resort after other methods have

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

Following aspects would a

been deemed unsuitable, it is essential that it is treated with great importance.

It is your responsibility to ensure that all equipment and materials provided for use by your em

dd to the challenges in developing combination products:

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

loyees are well maintained. Do not rely on your cleaning staff reporting issues back to you. Electric equipment should be out to date with PAT assessments, chemicals should not

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

e allowed to go beyond their shelf life and should be disposed of according to manufacturers instructions, and broken and/or faulty equipment should be removed from premises as so

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

n as it happens. These are not the responsibilities of cleaning staff, and procedures such as disposal of chemicals and the repair of equipment should only ever be carried out b

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

a competent, trained and authorised person.

In cases where cleaning companies have placed staff in specific places of work, employers should be aware that a common problem is th

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

Professional from academic institutions, pharmaceutical industries, health care indust

t the customer themselves ask the cleaners, not yourselves, to carry out certain tasks beyond the realms of their normal cleaning schedule. It happens frequently in cleaning cont

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

acts, and may seem to be a small point, but could prove to be a major Health and safety concern. Cleaning staff commonly feel obliged to meet your customers requests, but if a ta

.

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

k is beyond their usual cleaning schedule, it is likely that it requires different materials, equipment and even certain training and/or supervision, it may even require a risk as

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

Companies that provide selfless information through particip

essment and resulting risk control systems. Should there be changes to the cleaning schedule it is important the the client contacts you directly, and not simply ask the cleaners

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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You fill up your mug, jump in your car and head onto the dreaded commute of the day. Once you get to work chaos and more chaos surround you. Those half-an-hour breaks really don't cut it anymore. By the time you get home late into the evening you really don't have much time for anything but eating and sleeping which seems to keep adding to your waistline like your boss adds to your in box.

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