Useful Advices - Business

Electrical Safety Rogue Traders.

There are many companies out there who do not carry out the testing correctly. They do

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

not check the plugs or fuse ratings for appliances. All standard plug tops should be checked to ensure they are wired 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

orrectly, the terminals are secure, the fuse rating is correct and the general condition is ok. On moulded plugs the fus

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

rating should always be checked. On numerous occasions we have been called out to re-test another so called specialists

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

work. When selecting a company to carry out works look for the following:

1/ Are all engineers City&Guilds 2377 qualif

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

Combination pro

ied.

2/ Are the company accredited by an external organization for Portable Appliance Testing.

3/ Can the company prov

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

de full method and risk assessments.

4/ Is the equipment calibrated on at least an annual basis. (They will have certif

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

icates for each piece of equipment.)

5/ Does the company have relevant insurance cover.

6/ Obtain references from some

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

of there clients.

7/ Ensure that you are aware of the frequencies required between tests ie I.T equipment in an office

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

environment does not require an annual test.

If the company is genuine and proficient they will be able to provide all

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

of the above documents and advise on re-test frequencies for your business.

Hidden Costs

Watch out for hidden costs. C

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

Following aspects would a

ertain companies will also charge extra for replacement fuses, plug tops, extension leads and any minimal repairs. Norma

dd to the challenges in developing combination products:

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

ly these companies will use sub-contracted engineers and they are paid an added bonus for the amount of fuses, plugs the

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

y replace. Even if the item is ok. Be aware of the following points when selecting a contractor.

1/ Ensure that the quo

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

tation states whether fuses, plug tops, minimal repairs etc are included or not.

2/ Are there any extra charges for out

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

of hours or weekend work.

3/ How many sub-contractors do they use.

NOTE: Portable Appliance Testing covers 230v/110v a

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd some 415v appliances. All of these have a plug. Items that are isolated or are spurred ie Hand dryers, Wall Heaters,

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

industrial machinery would be covered under a periodic inspection and test to BS7671 and should not be tested as they ar

.

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

FIXED items not PORTABLE.

If you are unsure of work you have had carried out, or require any further information conta

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

Companies that provide selfless information through particip

ct us.

Call Free on 08000-856-996 e-mail mjenkins@earthcheckltd.co.uk

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Moving boxes and packaging materials provided by Red Line movers are the safest and easiest packaging solution of New York NYC. Red line movers provide packing boxes, Bubble wrap and other packaging material for safe moving

When a product is first launched into a market a firm will have to decide what price to charge.

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Useful Advices - Are You Safe? The Truth About Portable Appliance Testing

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