Advice You - Business

All mobile car washers and mobile auto detailers in Southern Californ

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

ia are required to prevent their wash water runoff from flowing into

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

Examples of combination products may in

storm drains. California law requires this and it is written right in

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

to the California Water Codes in 13.260, additionally it is aggressiv

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

ely enforced by municipality code enforcement along with the Californ

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

Combination pro

an Regional Water Quality Control Boards.

Mobile washers would be de

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

fined under a category of: Non-point source discharges under the city

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

or counties NPDES permit. The sub-category is called: surface cleane

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

rs. Mobile Auto Detailing often falls under this category too, althou

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

gh some municipalities have considered it automotive services. Orange

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

County CA, Los Angeles CO and Santa Clara Country all have automotive

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

Following aspects would a

services categories, which have re-classified the mobile car washes

dd to the challenges in developing combination products:

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

and mobile detailers into.

Remember even if this is done there will

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

still be people who clean gas stations concrete and restaurants equip

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

ment and facilities in the middle of the night which also will need c

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

tegories and different classifications; Fleet washing is a good point

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

Professional from academic institutions, pharmaceutical industries, health care indust

in that generally the water amounts used will preclude the evaporati

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

on and water will need to be picked up and discharged in almost all c

.

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

ases.

Please do not pollute the water as it puts a negative connotat

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

Companies that provide selfless information through particip

ion on the entire mobile cleaning and washing industry. Think on this

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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Advice You - Wash Water Runoff Issues in Mobile Detailing for CA

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