Subjects - Business

Speak of operations assessment, and we’ll hear its significant value. Speak of an audit, and we’ll run for the nearest em

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

ergency exit. There’s no difference between the two, yet that word audit chills us. But is an audit really designed to he

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

Examples of combination products may in

lp us or hurt us?

Improve Performance with Auditing

Problems most often arise from poor planning. Sometimes we’r

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

e uncertain if we’re tackling the correct issues and dealing with them the right way. However, we can improve our assumpt

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

ions about processes and performance with more effective auditing.

Management Process

The internal audit process

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

Combination pro

is not intended to be a ‘gotcha’ game. Rather, auditing helps management understand and validate the planning element. 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

y keeping an objective record of the process, we can learn to swim first and avoid that sinking feeling later.

Improv

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

e with Internal Auditor Training

Les Cornelius, Quality Assurance Coordinator at Lee BioSolutions, Inc., took a two-

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

day IRCA Internal Auditor Skills Class for the knowledge of getting improved results.

“I have to stay updated on new and

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

improved ways to design, assess and improve processes,” said Cornelius. “The checklists, planning an audit, designing an

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

audit program and conducting an audit – all are very helpful in preparation for the ISO certification audit.”

Busine

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

Following aspects would a

ss Assessment

By gathering objective evidence through observation, interviews and samplings of records, management c

dd to the challenges in developing combination products:

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

an make better decisions. This will help:

• Test organizational objectives and processes

• Write factual audit reports

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

that help improve the effectiveness of the management system

• Suggest ways to verify the effectiveness of any correctiv

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

e action to achieve the objectives

Audit Process

Auditing is the third phase of the Plan, Do, Check, Act process

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

approach – check. It is also one of the 8 quality principles of ISO, which allows managers to make better decisions base

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

Professional from academic institutions, pharmaceutical industries, health care indust

d not on subjective opinion but objective fact.

The audit process is a valuable step for improvement. Auditor training w

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

ill teach managers and executives how to improve the effectiveness of their management system, which is essential for ISO

.

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

9001 certification.

Auditing and ISO 9001

To fully understand the requirements of ISO 9001 and to facilitate au

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

Companies that provide selfless information through particip

dit teams, you can also take a five-day IRCA Lead Auditor course. After all, auditing is designed to help us, not hurt us

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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If communication is perceived to be the basic step towards achieving self-actualization, the act of rewarding - a sign of mutual recognition - is considered to be an essential way to motivate individuals to realize their potential and turn them self-transcendent. There are different ways and means to express one’s gratitude towards his/her associates, which are by and large situation-specific. In civilized societies, it is customary to appreciate one another’s progress through offerings. In the corporate world, it’s an obligation to acknowledge the professional contribution of individuals or institutional stakeholders through gifts of different forms, in order to maximize the overall business growth.

Preference and margins cannot be found in product enhancements and efficacy — these two improvements are simply the cost of doing business. In today’s crowded market space your preference and margins stem directly from your brand.

Many people have a natural fear of chemicals that catch fire easily. In fact, I know of some people who became so nervous whenever they have to come into the chemical areas that they lost their concentration and fumble about with their activities, visibly shaken. It is as if the whole place is going to explode in their faces anytime.

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