Useful Advices - Business

What is the risk?

Key control, or more accurately the lack of key control is one of the biggest risks that busi

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

nesses or property owners face.

Without a key control system you cannot be sure who has keys or how many keys t

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

Examples of combination products may in

hey have to your property. Not having a patent controlled key system leads to unauthorized key duplication, whic

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

h leads to unauthorized access to your property or employee theft.

Most key control systems utilize patented ke

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

s and or cylinders, these lock cylinders employ very precise locking systems that can only be operated by the un

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

Combination pro

ique keys to that system. Because the cylinders and or the keys are patented, the duplication of keys can only b

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

e done by factory authorized professional locksmiths.

The key blanks and lock cylinders are made available 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

to those same factory authorized professional locksmiths. Procedures may be in place to allow you to contract wi

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

th another security professional, should the need arise.

The control can be at the locksmith dealer level, at t

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

he distributor level, or at the manufacturer level.

All high security key control systems require specific perm

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

ssion to have keys originated or duplicated. These procedures assure the property owner or manager that they wi

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

Following aspects would a

ll always know who has keys and how many. If an employee leaves and you get the keys back, you can be reasonably

dd to the challenges in developing combination products:

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

assured that no copies of your keys are floating around.

Most systems have cylinders that will retrofit existi

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

ng hardware, keeping the cost of acquisition lower. Some systems employ different levels of security within the

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

ystem, still giving patented control, but not requiring ultra high security where it is not needed. These measur

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

es are again aimed at cost control.

Most systems can be masterkeyed, some will coordinate with existing master

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

Professional from academic institutions, pharmaceutical industries, health care indust

key systems. There are systems available that allow interchangable core cylinders that will retrofit existing in

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

erchangeable core systems.

Your Security Professional, can help you select the system most suited to your needs

.

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

.

Jim Newell

Please visit http://www.secureyourstuff.com for links to manufacturers sites and crime prevention

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

Companies that provide selfless information through particip

sites, many of which have additional security tips. This information could save your property or even your life

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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