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Every project should have a quality plan. In reality, very few do. The two main reasons people don’t produce a project quality plan are: It’s too complicated and they are overwhel

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

med by the jargon of quality in relation to compliance with standards, metrics and a range of acronyms. So let’s break this down into more simple terms to get a better understandi

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

Examples of combination products may in

ng of how to run a plan.

First off, what is quality? This definition will vary in every organization depending on their goals and mission. Quality has been defined by J.M. Juran

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

simply as “fit for use”. H. James Harrington states “Quality is meeting or exceeding customer expectations at a cost that represents a value to them”. Generally speaking we could

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

all agree that the definition is to make sure whatever is delivered is within the quality expectations of the organization.

If the quality of your goods and services are below ac

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

Combination pro

ceptable quality standards you are on the fast track to closing shop. When your organization under performs there are consequences. Keeping an eye on quality will prevent any seri

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

us fatal mistakes. A project quality plan will help you know what you need to measure, what the acceptable outcomes are, and how to accomplish all of this.

A project quality plan

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

is how and when "Quality Events" and "Quality Materials" are applied to a project. How the "Quality Materials" are applied to a project. They are the activities undertaken using

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

"Quality Materials" to validate the quality of the project. The artifacts used within an organization to assist a Project Manager improve quality in the project e.g. Templates, St

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

ndards, Checklists. These materials are used in "Quality Events". Technical project quality is usually judged by asking three questions: Does the system comply with corporate stan

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

dards for: user interface, documentation, naming standards etc.? Is the technology stable? Is the system well engineered so that it is robust and maintainable? By asking these que

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

Following aspects would a

stions you will get a better idea of where the quality of your program is. A project quality plan needs to includes a number of elements. You must id

dd to the challenges in developing combination products:

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

ntify what needs to go through a quality check? Typically what needs to be checked are the deliverables. Any significant deliverable from a project should have some form of quality

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

check carried out. A requirements document can be considered significant. Also, what is the most appropriate way to check the quality? If the end result is that a particular deliv

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

erable should meet a standard, then part of the quality checking should focus on compliance with the standard. This would indicate a "Standard Audit" could be the best approach. W

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

en should it be carried out? Most "Quality Events" are held just prior to the completion of the delivery.

If however there are long development lead times for a deliverable, it mi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ght be sensible to hold earlier "Quality Events". For example, if development of code for a particular module will take 10 weeks, it may be worth holding a code inspection after 4

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

weeks to identify any problems early and reduce rework.

Before beginning your project quality plan you should also identify who should be involved and what materials are needed.

.

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

Producing a project quality plan is not complex. It involves identifying all the deliverables at the start of the project and deciding how to best validate their quality. There is

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

Companies that provide selfless information through particip

an overhead in undertaking quality checks but this is offset by not having to fix things further down the line. Inevitably, the later you find a problem, the longer it takes to fix

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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