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This TQM article, is a continuation from Part 5a published on [June 01, 2006 08:10:51 pm]. I will share about problem or difficulties faced by the team when they use the tools in the IMPROVE PHASE.

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

Let’s see how we can handle problem or difficulties with Control lot and testing and Pilot the action / solution tools in the D.A.I.C. methodology for Improvement.

Just to recap, tools use

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

Examples of combination products may in

d in the IMPROVE Phase are listed below. In this article, I will cover the tools in bold:

Brainstorming of action / solution | Selection Grid | Benchmarking | Cost-Benefit Analysis| Control lot

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

and testing | Pilot the action / solution | Force-Field Analysis | Prevention Planner

Problem with Control Lot and Testing

It is quite a challenge to use this tool not the tool itself

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

but the planning go with it when need to run a control lot. First of all, the team need to consider several issues namely; Size of the control lot, duration of run, what parameter need to confirm, who wi

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

Combination pro

ll be involved, when to run it? Which shift to run it, and how is data to be collected. Due to lack of experience, the team struggle with it

I had a case where the team needs to confirm 4 process paramet

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

ers. When the control lot is in progress, team members set the 4 parameters at the same time then data is collected. At the end of the run, data collected are not useful to make any correlation as they di

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

not provide any pattern.

How to Overcome Control Lot and Testing Problem

Team need to understand the inter-relationship between each of the four parameters and how it influences

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

the coating thickness. By requirement, the team needs to run four control lots for each of the parameter as a variable separately. In another word, the team needs to adjust one parameter setting with the

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

rest the three locked. The idea is to see the effect of one parameter to the thickness by turn.

Problem with Pilot the action / solution

During the case of coating thickne

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

s, the team has confirmed the various setting after the control lot run. During the pilot run, team run into trouble even though all the four parameter wee set according to the new requirements. Productio

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

Following aspects would a

n supervisor may over react and set the four parameters back to the old setting. It did not help either. As a result, reject for coating thickness increased dramatically. How to Overcome Pil

dd to the challenges in developing combination products:

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

ot the action / solution Problem

When conducting the pilot run, team member must be around to work with the production supervisor to give him confidence about the new settings. When things m

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

ight go wrong, team members need to verify other process parameters before any change to the control lot parameter are changed. Team members need to explain to the production supervisor that process param

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

ters are sensitive to influence the outcome of the product. Therefore, all process parameters must be set in accordance to standards.

In summary, to minimise problem arising from changes to pr

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

oicess parameters, communication play an important role. A briefing to the objective of the pilot would help to munimise surprise not only to the production staffs, also to the team members. Now that the

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

Professional from academic institutions, pharmaceutical industries, health care indust

solution seem working alright, the team should move into the the CONTROL PHASE which will be my next article.

----------------------------------------------------------------

Disclaimer:<

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

r> All rights reserved. This article is written by the author based on his practical application experience. All definitions and interpretation of terminology are his point of view and has it has no inte

.

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

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

Companies that provide selfless information through particip

reprint or re-publish this article as long as you include my resource box at the end of this article. Please ensure that the URL in the resource box remain intact and it is linked to the author's website

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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