Main Subject - Business

Any responsible person, even with limited formal instruction or experience, can do a simple fire risk assessment. More complex buildings will need to be assessed by a person with full trai

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

ning and experience in fire risk assessment.

Mainly companies and building owners will be affected by the new legislation but it could be anyone who has some control over premises. Fire c

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

Examples of combination products may in

ertificates will no longer be valid.

Under the new regulations it is the responsibility of employers to do a risk assessment of their places of work, which must contain provisions concern

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

ng fire safety measures in the workplace.

The responsible person must go over the risk assessment frequently to keep it current, particularly if: . There is reason to believe that it is

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

no longer valid; or . There has been a major change in the matters to which it relates, or there have been expansions or substantial changes in the organisation of work

The risk assessme

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

Combination pro

t should be done to make sure that appropriate fire precautions, maintenance and management measures are in place to guarantee the safety of anyone who might use your premises.

The Fire a

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

nd Rescue Authority will now examine premises and undertake audits of fire risk assessments to put into effect the requirements of the Regulatory Reform Order.

The Five Steps To Fire Risk

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

Assessment:

Step 1: Identify fire hazards
Is there a system for controlling the amounts of combustible materials and flammable liquids and gases, including cleaning fluids, station

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

ry and waste, kept in the workplace?

Is the system working correctly? Are all combustible materials and flammable liquids and gases stored safely? Are all items of portable electrical equ

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

ipment checked frequently and fitted with the correct rated fuses?

Step 2: Identify the persons at significant risk in case of fire
Think about who might be in or near your premises

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

that would need to know about your fire protection systems - including employees, people in adjoining buildings, visitors or contractors.

Is there an adequate number of proper exits of su

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

Following aspects would a

itable width for the persons present? Do the exits lead to a place of safety? Are passageways and escape routes free from obstacles and tripping hazards? Are steps and stairs in a good sta

dd to the challenges in developing combination products:

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

te of repair? Are final exits always unlocked when the premises are in use?

Step 3: Evaluate the risks
Control sources of ignition and the use and storage of flammable materials. Do

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

rocedures and practices avoid the use of combustible materials or processes that use heat?

Has thought been given to all cost-effective measures that can be taken to prevent the incidence

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

of arson? Have employees been taught how to call the fire brigade, the use of the fire extinguishers and basic fire prevention?

Step 4: Record your findings and action taken
This de

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

ends on the size of your workplace and the likelihood of fire. If you employ five or more people have you recorded the findings of the fire risk assessment?

Have you told your employees o

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

Professional from academic institutions, pharmaceutical industries, health care indust

r their representatives about your findings? If you have prepared a final report has it been shown to your employees? If you share the workplace with others do they know about the risks yo

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

u have identified?

Step 5: Keep assessment under review
Has a procedure been set up to go over the fire risk assessment at regular intervals?

The task of complying with the Fire Saf

.

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

ty Order rests with the "responsible person". Under Article 9 of the Order the responsible person must ensure that a fire risk assessment is carried out to identify the general precautions

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

Companies that provide selfless information through particip

required.

Detailed advice on carrying out a fire risk assessment is contained in the Home Office/Scottish Executive/Northern Ireland DoE/HSE publication, Fire Safety: An Employer's Guide

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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