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Every business must strive to provide quality products and services to customers. To achieve that objective the company must draw well thought out policies and procedures to ensure 100% achievement of the targets.

Here are some tips to ensure that your business attains and enhanc

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

e quality:

Document Quality Objectives and Procedures

Quality management objectives, policies and guidelines must be set and published in manuals, in the business newsletter, on the notice board and wherever appropriate. This is to educate and remind employees and management and

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

Examples of combination products may in

serve as guidelines. Even suppliers and customers should be informed on the company’s quality management policies and where appropriate be advised to adhere to them.

Educate Employees on Quality Requirements

For total quality management to work everyone in the business must be e

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

ucated and trained in its principles. Everyone must be brought on board – from the cleaner, the gardener, the electrician, the clerk, and manager etc. Employees should be made to own the process and not to feel left out of the action. Employees should be organised in quality circl

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 (groups) within departments to brainstorm and implement quality issues.

Foster a Policy of Zero Tolerance to Defects

One error could cause a thousand corresponding errors or negative consequences. Let’s take a typical example of a car. A loose nut on the tyre can cause the tyr

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

Combination pro

to run inappropriately and cause an accident. The accident may affect you and whoever you are carrying in the vehicle and probably passers by and other vehicles. It may lead to deaths and injury. The multiplier effect may affect your life and other people’s lives without your kno

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

ledge just from a single defect. This is therefore to show every aspect of your business must be taken seriously.

All products and services must be checked for compliance to specifications and procedures. The business must foster a policy of zero tolerance to defects and all effo

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

ts should be made towards that end.

Use TQM Tools and Statistical Techniques to Measure Quality

Total Quality Management Tools (TQM) tools are a necessary component if you want to measure and enhance quality. Tools such as checklists, flowcharts, Gantt charts, Ishikawa diagrams

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

nd the like are important in the quality management process. Statistical techniques help to measure quality levels. By applying such techniques you would have set your business on the quality path. Ensure that you have minimum and quality levels for your products and services. You

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

can use industry, national or international quality standards. If your business attains such standards, inform your customers by publishing your attainment or displaying the quality mark appropriately.

BRAINSTORM PROBLEMS AND SOLUTIONS

A good approach to solving problems and tec

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

nical challenges is to form quality circles, which will brainstorm problems and solutions and forward to management for approval. Root problems should be brainstormed, key solutions to them proposed and forwarded to management for approval.

REDUCE WASTAGE

Research has shown that

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

Following aspects would a

most businesses have a 20% wastage rate. Check your dustbin. What do you see? What about the stores? How many goods have been returned because of defects in the past three months? You should work to attain zero defect in your products or services. Ensure that goods are made to sp

dd to the challenges in developing combination products:

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

cifications. Use statistical techniques to measure quality. Reduce paperwork. Improve the design and substance of your goods and services. Tighten controls. Reduce pilferage.

DELIGHT THE CUSTOMER

Quality management is not static but is a continuous process with the aim of ever d

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

lighting the customer. Remember that your competitors are working overtime to get your customers and stay on top. You should work ever harder to get their customers and delight your customers often. You can do that by anticipating customers’ needs. Do surveys and research on custo

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

ers’ needs and expectations. Check what competitors are offering. Take action to continuously improve your goods and services.

LEARN FROM THE GURUS

Total quality management embodies a set of rules, policies and guidelines which are best learned from the pioneers. Get yourself bo

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

ks and manual quality management especially from the gurus such as Deming, Juran Crosby, Ishikawa, Fergenbaum and the like to learn more. Most of their ideas may be about manufacturing or not directly relevant to your business but they could be adapted to your business needs and r

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

Professional from academic institutions, pharmaceutical industries, health care indust

quirements.

BE ACTION ORIENTED

A problem plaguing many people and businesses is their failure to take positive action and be mired by rhetoric and apathy. Management is tied down in endless meetings, conferences ad seminars whose recommendations are never implemented.

Prepare a

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

action plan of your recommendations and solutions with set time frames and review periods. Check what makes action impossible to implement or bottlenecks to implementation.

Your action plan should be divided into short term, medium term and long-term activities. It should be bac

.

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

ed by a budget for financing it.

Quality management or TQM is a broad subject and you require to learn more than what is provided briefly here. TQM is not the panacea for all business problems but they can be reduced by 50% if you adopt it appropriately.

To succeed in business y

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

Companies that provide selfless information through particip

u need the right business plan backed by adequate capital, the right product or service, the right marketing strategy, the right location and the right implementation strategy.

Quality management if well implemented could set your business on the path to profitability and success

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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