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Companies are required to take steps necessary to ensure that the Pollution Prevention plan works efficiently. These plans when implemented are considered Best Management Practices or

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

(BMPs) Examples of these practices include:

Maintenance procedures
Employ positive activities and procedures that prevent or reduce pollutants from entering waterways
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in
l>

BMPs can be written plans or devices that physically prohibit discharge of pollutants A sample of products that help companies comply with the requirements of the BMPs:

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

on Prevention Act extends to all media including air water and land. Reducing pollution at the source is the main goal for the P2 act. To clarify the new initiative regarding Pollution
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Prevention, new industries sprang up to bridge the knowledge gap between the government statues and the proper implementation of the governmental regulations. These professional consult
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
nt were advisers to business clients on pollution prevention products.

The governmental response to the global pollution is found in the Pollution Prevention Act enacted in 1990 throu
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
gh the Environmental Protection Agency. The EPA has specific mandates considered as the Best Management Practices to prevent pollution by following specific activities that not only
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
reduce but eliminate polluting activities.

The purpose and scope of the document seeks to provide the following results

1)Reducing or eliminating waste at the source

(This is done
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
by modifying production processes)

2)Promoting the use of non-toxic or less-toxic substances

3)Implementing conservation techniques

4)Recycling of materials rather than adding these m
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
aterials to the waste stream

Taking the Pollution Prevention Act from a paper document to implementation involved strict guidelines that states and municipalities had to follow: Spe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ialized consultants can provide products and information to industrial locations to help them develop a comprehensive program to address the problem. Specific guidelines for spill con
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
tainment, hazardous material handling and safety measures may require onsite analysis.

Some of the far reaching activities that are implemented by companies and municipalities includ
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
e:
- Wastewater pretreatment
- Septic tank programs
- Watershed
- Groundwater protection programs
- Educational activities targeted at residents
- Technical assi
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
stance and compliance assistance provided to local businesses and industries
Local partnership activities between government agencies
Specific guidelines and practices of munic

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

ipal and county facilities

The Environmental Protection Agency (EPA) developed the standards and procedures to enforce the activities that would insure a measurable and positive

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

effect on the quality of the environment.

As better methods of detection of pollution were discovered, the serious consequences of the problem of pollution is ever expanding. The sou

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

Professional from academic institutions, pharmaceutical industries, health care indust

rce of pollution was more extensive than first realized. The most difficult sources of pollution were identified and brought to the attention of governmental agencies that educate indus

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

tries and the public regarding the problem. There are also governmental guidelines that represented the best practices for pollution control.

These strategies include:

Educ

.

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

ate local organizations so they are able to meet compliance standards

Improve practices and procedures to ensure continued compliance

Encourage local organizations to move bey

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

Companies that provide selfless information through particip

ond the basic environmental compliance thresholds

Following the guidelines and procedures of Pollution Prevention (P2 ) provides an unexpected benefit to companies and communities

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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