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Document destruction has become mandatory by law, in order to prevent the misuse of vital information by unscrupulous individuals. There are a number of Federal and State Enact

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

ments such as the FACTA (Fair and Accurate Credit Transactions Act) and HIPPA (American Health Insurance Portability and Accountability Act). They mandate the destruction of do

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

Examples of combination products may in

cuments in a proper manner to prevent identity theft. Documents falling under this category include:

• Blank Checks
• Tax Records
• Payroll Records
• Medical Re

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

cords
• Personnel Records
• Bank Statements
• Financial Statements
• Legal Documents
• Mailing Lists
• Office Correspondence
• Photocopies

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

> • Invoices

The list is unending. The best way to destroy documents is by shredding them. When confidential papers are simply thrown into the trashcan, visitors, mainte

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

Combination pro

nance staff and other employees can easily access them. This is a grave security risk.

In small businesses or homes where the wastepaper output is limited, this can be taken c

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

are of by installing shredding machines for in-house shredding. But, in the case of big businesses and commercial establishments, in-house shredding is a practical impossibilit

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

y. This is due to the large quantity of paper to be shredded. In such businesses, the services of professional shredding service providers are very useful. Once contracted, the

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

se professional companies come at a prescheduled time in special trucks to conduct the shredding onsite. In the case of offsite shredding, they carry it to the company warehous

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

e and documents are destroyed there. In both cases, the shredded material is later sent for recycling.

Recycling includes pulping the shredded material, which is then used to

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

make recycled paper products. The recycling process is comprised of different stages:

1. First, the discarded paper is converted into ‘re-suspension' or pulp slurry in clean w

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

Following aspects would a

ater, to separate the component fibers.
2. The slurry is then treated chemically to remove non-fibrous contaminants and is also given a detergent washing.
3. In the

dd to the challenges in developing combination products:

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

case of white paper, there is a bleach treatment involved.
4. The fresh recycled paper is made with a mixture of the pulp and some amount of virgin fiber.
5. In the

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

process, some amount of unusable material referred to as ‘sludge' is left behind. This is mainly weak fiber and old ink and is either used by farmers as fertilizer, buried i

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

n a landfill or burned in paper mill furnaces to generate energy.

The pulp mixture that is leftover is then diluted with more fresh water. This process creates what is oft

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

en referred to as a slurry, and then is loaded into a paper machine. Inside the machine the slurry is filtered and compressed to remove all of the water. Now the material is re

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

Professional from academic institutions, pharmaceutical industries, health care indust

ady to be sent through steam heated drums that ultimately form paper sheets.

For an effective recycling program, employees of any company consuming large amounts of paper shou

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

ld first be educated about the available waste paper recycling methods. Then, through interactive sessions, they need to be informed about the benefits of recycling and the way

.

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

s in which they can positively contribute to the program. This can be as simple as monitoring the usage of paper and segregating white paper from colored paper. They can be sto

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

Companies that provide selfless information through particip

red in separately labeled trashcans.

Every time waste paper is recycled, there is conservation of valuable energy, resource conservation and reduction in waste disposal costs.

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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