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In the effort to achieve total quality management in an industry, striving towards constant improvement is a must. A proper recognition and reward process of an organisation motivates the staff of an organisation to achieve its objectives.

Many compa

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

nies are presently addressing the issue of reward and recognition for their as part of quality and continuous improvement programmes, but there remains no general guidelines or descriptions of such programmes which are readily available. These compani

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

Examples of combination products may in

s have made several attempts to create a process of employee reward and recognition for quality activities as part of its process of continuous improvement. All such attempts have had little success, resulting in the various systems losing their prest

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

ge among employees.

In Australia, a new process for employee reward and recognition was developed through a company’s quality committee. It consists of 7 steps which can be used generically for any firm wishing to implement a system for staff recogni

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

ion and reward.

The steps are:

1) Categories for awards - The emphasis of the reward and recognition process is to stimulate employee involvement in the culture change towards continuous improvement and aims to recognise those individuals that provi

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

Combination pro

e an example of desirable behaviour towards the company goals. Successful nominees are expected to have not only performed their defined roles but also to have contributed additional dimensions beyond their defined roles in the area of culture improve

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

ent.

2) Nominations - Nominations for each of the categories are received on a quarterly basis. They are received from any individual in the company. The only prerequisite for a nomination is that it must be handed to the quality systems manager by

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

he due date and on a formal nomination form, thus providing some degree of consistency.

3) Review of nominations - Each nomination is accepted on the basis of the quality committee review at a meeting within the first week after the close of nominat

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

ons for the quarter. The quality committee consists of eight representatives (not necessarily senior managers) of each area of the business and includes the general manager as its chairperson, at least two executives and the quality systems manager.

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

ach nomination is reviewed for acceptance on the basis of the criteria described above, whether there is any disciplinary action pending for the nominee, together with an assessment of the most suitable category for the nomination.

4) Recognition o

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

successful nominations - Successful nominations are formally recognised at a company meeting, which all employees are invited to attend. The nominee, nature of the nomination and category to which the nomination has been assigned is also acknowledged

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

Following aspects would a

. Each successful nominee receives a certificate from the quality committee, endorsed by the chairperson of the committee, congratulating and thanking them for their contribution.

5) Review of successful nominations - Successful nominations are assi

dd to the challenges in developing combination products:

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

ned to one of the members of the committee for follow-up review to decide the eventual quarterly award winner of the category. Committee members are not permitted to review applications for employees within their own department or area of business.

6

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

Awards - Each category winner is given an award consisting three components. One is that of a monetary component, consisting of either a getaway weekend package at a prestigious hotel or a money order to a leading retail store. Another is a framed ce

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

tificate from the company and an accompanying certificate of endorsement from the Western Australian office of the Australian Quality Council. Also there will be an individual and group photograph photos used for publication in the company newsletter

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

nd are placed on a notice board in the company canteen. Each category winner also receives an individual copy of the photo. All winners are announced at a second company meeting which is attended by a representative of the Australian Quality Council w

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

Professional from academic institutions, pharmaceutical industries, health care indust

o awards the successful nominees with their award of endorsement.

7) Annual quality award - Quarterly winners of each category also qualify for the Annual Quality Award. The categories used for quarterly award winners do not apply in the annual award

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

all 12 quarterly winners are compared with one another. Scores for the annual award represent an average of the sum of the quarterly review (performed during the year) and a repeat review (specifically for the annual award) utilizing different fellow

.

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

workers and customers. Thus the annual award winner is decided on the highest score from six fellow workers, four customers and two separate assessments by the direct manager.

Any company wishing to implement a reward and recognition process can cons

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

Companies that provide selfless information through particip

der this 7 step process. This process can also be modified to individual company needs by varying the minimum score required for qualification (however, it is not recommended to remove a minimum score) and the rewards could also be changed accordingly

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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