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Advice You - Am I Providing a Safe Working Environment for my Staff?
Health and Safety is a very in depth and complicated subject, the aim of this article is to highlight a few of the legal issues a business owner should consider if they want to improve wor
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
king conditions.
1. By law every business that employs 5 or more employees, including part time staff, must display an up to date Health and Safety policy. An up to date policy must be si
1. By law every business that employs 5 or more employees, including part time staff, must display an up to date Health and Safety policy. An up to date policy must be si
; 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
ned and dated annually.
2. By law every business that employs 5 or more employees, including part time staff must carry out and record their risk assessments.
Other considerations to con
2. By law every business that employs 5 or more employees, including part time staff must carry out and record their risk assessments.
Other considerations to con
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ider when looking to improve working conditions:
1. Temperature – The temperature should be comfortable all year round
2. Computer users – Should use a suitable ergonomic chair, a footre
1. Temperature – The temperature should be comfortable all year round
2. Computer users – Should use a suitable ergonomic chair, a footre
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
t, a wrist support mouse pad and work in a well ventilated well lit (by diffuser lighting) office. Computer users should also be given free annual eye tests.
3. Toilets - Toilets and runn
3. Toilets - Toilets and runn
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ng water should be provided and be easily accessible for your staff. Toilets should be cleaned and stocked regularly.
4. Lone workers – If you have a cleaner who works out of hours alone,
4. Lone workers – If you have a cleaner who works out of hours alone,
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
you must provide some means of a safety system, this can be done easily by a call from a mobile at set times. The cleaner should also be fully aware of all the Health and Safety issues wit
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
in the building this should also include the chemicals they are using and what to do in the event of an accident, especially as most cleaners work alone.
5. PPE – Make sure you provide yo
5. PPE – Make sure you provide yo
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
r workforce with the proper protective equipment, not the cheapest. Too often unsuitable PPE is obtained for the workforce; this usually results in employees not using the equipment as the
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
see it as a hindrance.
6. Rest – Make sure all your staff take a break, accidents are more likely to happen when staff are tired or not concentrating. This is very important for workers
6. Rest – Make sure all your staff take a break, accidents are more likely to happen when staff are tired or not concentrating. This is very important for workers
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
perating heavy plant and machinery or using hazardous substances.
7. Slips & Trips – If you have any external concrete steps they should be covered with non slip paint for wet conditions.
7. Slips & Trips – If you have any external concrete steps they should be covered with non slip paint for wet conditions.
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
If there are any trailing leads they should be covered. Signs are usually only seen after you have tripped over something.
8. Do you have a fire alarm? How often is it tested?
9. Heavy l
8. Do you have a fire alarm? How often is it tested?
9. Heavy l
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
fting – Provision should be taken so workers are not expected to lift heavy equipment.
10. Accident procedures and reporting – Accidents happen it is an avoidable part of our lives, howev
10. Accident procedures and reporting – Accidents happen it is an avoidable part of our lives, howev
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
r it is how we deal with them and learn from them, even ‘near misses’ that make us all more aware of our surroundings.
11. Do people visit your workplace? If yes, they should be fully awa
11. Do people visit your workplace? If yes, they should be fully awa
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
e of the dangers within your workplace.
This article has just touched the surface of a complicated often misleading subject. In my last job I was responsible for the Health and Safety of
This article has just touched the surface of a complicated often misleading subject. In my last job I was responsible for the Health and Safety of
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
ver 300 people most working with heavy plant and machinery. It took me a long time to improve working conditions and change ethos’s my advice to anyone who would like to improve working co
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
ditions is prioritise what you would like to do and implement it in order. Everyone dislikes change so look to implement systems and changes in a steady fashion. The workforce should be aw
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
re it can be very difficult for the owners of a company to make or introduce improvements if there are financial constraints of the company.
If you would like any more information on this
If you would like any more information on this
.
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
subject then please visit our website at www.bizseller4u.com
Peter Arkwright recently retired from the military; he is now the Mana
Peter Arkwright recently retired from the military; he is now the Mana
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
ing Director of Bizseller4u Ltd - Providing business solutions in sales, advertising, funding, debt collection and recovery plans
This article is free to republish with the signature bloc
This article is free to republish with the signature bloc
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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