Tags |
|
|
Links |
|
|
Business Articles - Risk Assessment in The Workplace - Part 1
What is risk assessment?
A risk assessment is simply a careful examination of your workplace, to identify what could cause harm to people, so that you can decide as to whe
A risk assessment is simply a careful examination of your workplace, to identify what could cause harm to people, so that you can decide as to whe
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
ther you have taken enough precautions or should do more to prevent harm from being caused.
Work accidents and work related ill health, can ruin lives, and seriously affec
Work accidents and work related ill health, can ruin lives, and seriously affec
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
t your business also, if output is lost, machinery is damaged, insurance costs increase, or you have to go to court.
You are legally required to assess the risks in your w
You are legally required to assess the risks in your w
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
orkplace.
The important thing you need to decide is whether a hazard is significant, and whether you have taken satisfactory precautions to minimize the risk.
If you are
The important thing you need to decide is whether a hazard is significant, and whether you have taken satisfactory precautions to minimize the risk.
If you are
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
a small firm owner, and you are confident you understand what is involved, you can carry out a risk assessment yourself. You do not have to be a Health and Safety expert. I
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
you are a larger firm, then you may want to assign a responsible employee, safety representative or safety officer to carry out the task. You can also obtain advice from o
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
utside companies, who have specialised in this type of work.
What is Hazard and Risk?
A hazard means anything that can cause harm. To give you a basic idea, think of chem
What is Hazard and Risk?
A hazard means anything that can cause harm. To give you a basic idea, think of chem
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
icals, electricity, working at heights etc etc.
A risk is the chance, high or low, that somebody will be harmed by the hazard.
There are five steps in a risk assessment:
A risk is the chance, high or low, that somebody will be harmed by the hazard.
There are five steps in a risk assessment:
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Step 1. Look for the hazards.
Step 2. Decide who might be harmed and how.
Step 3. Evaluate the risk and decide whether the existing precautions are adequate or whether m
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
ore should be done.
Step 4. Record your findings.
Step 5. Review your assessment and revise it if required.
Do not overcomplicate matters. In the majority of firms in th
Step 4. Record your findings.
Step 5. Review your assessment and revise it if required.
Do not overcomplicate matters. In the majority of firms in th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
commercial, service and light industrial sectors, the hazards are few, and those that do exist are fairly obvious. Checking them is mainly a matter of common sense, but a
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
lso a required and necessary action.
You probably know already, whether you have machinery that could cause harm, or if there is an awkward entrance or stairway where some
You probably know already, whether you have machinery that could cause harm, or if there is an awkward entrance or stairway where some
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
one could be hurt. If so, check that you have taken all reasonable precautions you can to avoid accidents and prevent injury.
Lets take a closer look at Steps 1 and 2.
St
Lets take a closer look at Steps 1 and 2.
St
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ep 1. Look for the hazards.
If you are doing the assessment yourself, walk around your workplace and look at what could reasonably be expected to cause harm. Ignore the tr
If you are doing the assessment yourself, walk around your workplace and look at what could reasonably be expected to cause harm. Ignore the tr
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ivial (for now) and concentrate on significant hazards which could result in serious harm.
Ask your employees what they think. They are the ones who are working with the v
Ask your employees what they think. They are the ones who are working with the v
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
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
rious components on a daily basis, and will therefore know where the problems are. They may have noticed things which are not immediately obvious. Manufacturers instruction
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
s or data sheets can also help you spot hazards and put risks in their proper perspective.
Step 2. Decide who might be harmed and how.
For each identified hazard you shou
Step 2. Decide who might be harmed and how.
For each identified hazard you shou
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ld then decide who might be harmed and how. And of course you will then be able to decide on a course or action that will prevent the hazard from causing risk.
Do not forg
Do not forg
.
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
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
et about young workers, trainees, expectant mothers etc who may be at particular risk.
Do not forget cleaners, visitors, contractors, maintenance workers etc who may not b
Do not forget cleaners, visitors, contractors, maintenance workers etc who may not b
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
e in the workplace all the time.
Do not forget members of the public, or people you share the workplace with, if there is any chance they could be injured by your activity
Do not forget members of the public, or people you share the workplace with, if there is any chance they could be injured by your activity
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.businessarticles.org.ua/article/3841/businessarticles-Risk-Assessment-in-The-Workplace--Part-1.html">Risk Assessment in The Workplace - Part 1</a>
BB link (for phorums):
[url=http://www.businessarticles.org.ua/article/3841/businessarticles-Risk-Assessment-in-The-Workplace--Part-1.html]Risk Assessment in The Workplace - Part 1[/url]
Related Articles:
Golf Course Designers - How to Choose an Architect to Design Your Golf Course
Productivity in Spain - Where are the Opportunities?
How To Win New Graphic Design Clients And Keep Old Ones Coming Back
Bookmark it:
|