Subjects - Business

An operations manual can act as a tool for training employees and empowers them to your business runni

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

ng smoothly when you are out of the office. Though it may seem like a lot of work, the effort put 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

your operations manual can save you money that could otherwise be wasted on mishandled procedures and

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

employee training time.

Every operations manual is different so yours should be tailored to your spec

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

ific business needs. You may want to create separate manuals for each department or job description in

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

Combination pro

your company. Your operations manual should grow and change with your business so make sure to update

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

the contents often. Store the manual in a sturdy binder with dividers to keep it organized, making it

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

easy to update the contents and replace pages when processes change.

The following is a suggested lis

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

of topics to address in your manual:

•Company Overview & History

•Mission Statement

•Opening Proce

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

dures

•Closing Procedures

•Cash Handling

•Daily Tasks

•Alarm System Operations

•Safe Opening and

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

losing Procedures

•Contact Numbers for Emergencies or Information

•Employee Shift Coverage

•Website

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

Following aspects would a

Procedures

•Customer Service Procedures

•Sales Procedures

•Sales Quotas

•Commission Payments

•Or

dd to the challenges in developing combination products:

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

der Processing

•Credit Card Processing

•Refunds and Returns

•Gift Certificates

•Special Orders

•S

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

ipping & Receiving

•Equipment Handling

•Equipment Maintenance (replacing printer cartridges, receipt

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

tape, etc.)

•Security Procedures

•Emergency Procedures

•Product Pricing and Discounts

•Other Misc

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

llaneous Procedures and Anything Specific to the Way Your Business Operates

Don’t forget to use you

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

Professional from academic institutions, pharmaceutical industries, health care indust

r operations manual as a training tool for new hires. To make sure the information is accurate and val

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

uable, ask your employees for feedback on the contents. Ask if they have questions about the topics co

.

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

ered and if the instructions are clear and easy to understand. Remember that this is a valuable busine

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

Companies that provide selfless information through particip

ss tool for you and your staff so keeping it current should be an important priority for your business

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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