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Digg It - Ensuring the Legal Standard of Health & Safety in Your Business
Whether you’ve recently launched a new business or just taken over from a previous owner, it’s likely you’re floundering amidst the multitude of regulations and requirements the law bestows upon you. Perhaps the worst mistake of all is complete ignorance – something which is hard to avoid when there are several hundred issues vying for your attention.
So what exactly do you nee
So what exactly do you nee
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
d to cover in your workplace? It’s all very well putting the equipment and workers you need into a room with some desks, but just like setting up a hamster cage – you need to be aware of safety concerns. Luckily though, it’s unlikely you’ll have to worry about your employees trying to gnaw their way out…
So what do you need to look into? Follow these guidelines and you can be s
So what do you need to look into? Follow these guidelines and you can be 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
Examples of combination products may in
re your workplace falls under government requirements to ensure you do everything you can to make your business safe and healthy for workers and the environment.
1. Fire Safety
It’s highly likely that your local fire station will have a designated Fire Safety officer who will be more than pleased to talk to you about fire safety in your workplace. The kind of things
1. Fire Safety
It’s highly likely that your local fire station will have a designated Fire Safety officer who will be more than pleased to talk to you about fire safety in your workplace. The kind of things
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
they’d be asking you to look at are escape routes, fire-fighting equipment (which requires regular maintenance), emergency lighting, staff training, storage of flammable materials, fire alarms and fire-resistant doors and walls.
Some businesses require a fire certificate – this is you if your workplace is a public place (restaurant or shop), has more than one business operatin
Some businesses require a fire certificate – this is you if your workplace is a public place (restaurant or shop), has more than one business operatin
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
in the same building, or employs more than 20 people (or more than 10 of your people work above or below the ground floor).
New legislation coming into effect in 2006 will also require that your Fire Safety is put in the hands of a responsible person at your workplace. Designating those responsibilities to one of your employees can be efficient delegation, and also of course i
New legislation coming into effect in 2006 will also require that your Fire Safety is put in the hands of a responsible person at your workplace. Designating those responsibilities to one of your employees can be efficient delegation, and also of course 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
crease staff morale (by demonstrating confidence in their abilities).
By far though, the best first step is to get in touch with your local Fire Officer. Phone the non-emergency fire station number and ask them for some information.
2. Risk Assessment
Every workplace is expected to carry out risk assessment, in order to ensure that every precaution has been put int
By far though, the best first step is to get in touch with your local Fire Officer. Phone the non-emergency fire station number and ask them for some information.
2. Risk Assessment
Every workplace is expected to carry out risk assessment, in order to ensure that every precaution has been put int
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
place. If there are more than five people in your office, you are also expected to record your risk assessments and store them for reference.
When carrying out your assessment, you should be looking for potential hazards such as trips or falls, tasks carried out at height, possible exposure to toxins, high noise levels, moving vehicles and exposure to fire and explosions.
You
When carrying out your assessment, you should be looking for potential hazards such as trips or falls, tasks carried out at height, possible exposure to toxins, high noise levels, moving vehicles and exposure to fire and explosions.
You
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
can find more information on properly putting together and recording a risk assessment here. As a conclusion to your risk assessment, you will also want to designate a First Aider amongst your employe
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s, and ensure they have covered the basic first aid courses.
3. Sanitary Facilities
There are some basics standards of comfort that all businesses are expected to maintain for their employees and clients. These include adequate and sanitary lavatory facilities, hand towels and soap. Hot running water and drinking water should also both be available.
Room temperatur
3. Sanitary Facilities
There are some basics standards of comfort that all businesses are expected to maintain for their employees and clients. These include adequate and sanitary lavatory facilities, hand towels and soap. Hot running water and drinking water should also both be available.
Room temperatur
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
should be at least 16 degrees Celcius for seated and relatively inactive employees, or 13 degrees Celcius for active and mobile employees. If your room temperature falls below these levels, you must provide local heating such as fan heaters or gas heaters.
Comfort and sanitation is often a matter of common sense, and keep in mind that your employees have no choice but to come
Comfort and sanitation is often a matter of common sense, and keep in mind that your employees have no choice but to come
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
o their place of work every day. Make it a comfortable, appealing and clean place of work, and not only will you be fine in the eyes of the law but you’ll have a happy workforce too.
4. Equipment Safety
The Provision & Use of Work Equipment Regulations 1998 (PUWER) state that you must ensure all equipment given to employees is safe and of good standard. Depending on
4. Equipment Safety
The Provision & Use of Work Equipment Regulations 1998 (PUWER) state that you must ensure all equipment given to employees is safe and of good standard. Depending on
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
your business, this may encompass a very large part of the work you will have to do to make your workplace safe and legal. For workshops and building contractors, all your machinery will need to be tested and regularly maintained. Even in a small office, ensure all electrical equipment is tested and certified (this is not a legal requirement, but you are required by law to ensur
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
electrical equipment is as safe as you can make it, and testing covers all the legalities)
You also have a responsibility to ensure all employees are fully trained to use the equipment they work with, and you can benefit from having such training documented somewhere for future reference.
It is also a good idea to have some focus on employee health, such as posture (for chair
You also have a responsibility to ensure all employees are fully trained to use the equipment they work with, and you can benefit from having such training documented somewhere for future reference.
It is also a good idea to have some focus on employee health, such as posture (for chair
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
based workers), eye-strain (when using screens and computers), repetitive strain injury and other work-related health risks. Investing in your employees in this way will pay dividends.
5. Reporting Accidents
In accordance with the Recording of Injuries, Diseases & Dangerous Occurrences Regulations 1995 (RIDDOR), you are required to document any of those stated occur
5. Reporting Accidents
In accordance with the Recording of Injuries, Diseases & Dangerous Occurrences Regulations 1995 (RIDDOR), you are required to document any of those stated occur
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
rences in your workplace. Such records must be kept at your usual place of business for at least three years after the fact, and you can store them in whatever form you please. Hand written, typed and electronic reports are all fine, or you can use the statutory Accident Book (B1510) as a record.
Occasionally an incident may have to be reported to the authorities, if it is part
Occasionally an incident may have to be reported to the authorities, if it is part
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
cularly serious. Major injuries, any resulting in death, certain diseases and any injury preventing an employee carrying out their duties for over three days should all be reported to the authorities.
For more clarification on what accidents need to be reported, and how to keep concise and legal records of staff mishaps, see ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
For more clarification on what accidents need to be reported, and how to keep concise and legal records of staff mishaps, see ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
ayer?topicId=1073956375&r.l3=1073961069&r.l2=1073859149&r.t=RESOURCES&r.i=1073791658&r.l1=1073858805&r.s=e">this page.
In a first read-through, that might all seem overwhelming, but once put into action a lot of these things take care of themselves. Good Electrical Testing companies, for example, will give you the option of booking maintenance and re-testing so that you don
In a first read-through, that might all seem overwhelming, but once put into action a lot of these things take care of themselves. Good Electrical Testing companies, for example, will give you the option of booking maintenance and re-testing so that you don
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t need to remember yourself. Delegating responsibility to staff members saves a bit more memory, and documentation and reports are easy to keep if you don’t leave them to build up.
You can find further helpful sources of information on Health & Safety for business-owners at these websites:
.
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
You can find further helpful sources of information on Health & Safety for business-owners at these websites:
.
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
&itemId=1074408849&r.l3=1073961069&r.li=1075904481&r.l2=1073859149&r.l1=1073858805&r.s=a">Book a Course on Health & Safety
Health & Safety Homepages
Governments Webpages for Health & Safety at work
Health & Safety Homepages
Governments Webpages for Health & Safety at work
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
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Health & Safety Executive for England
Health & Safety Executive for Northern Ireland
American Health & Safety Institute
U.S Department of Labour
Health & Safety Executive for England
Health & Safety Executive for Northern Ireland
American Health & Safety Institute
U.S Department of Labour
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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