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This TQM article is a continuation of the Part 4a article, the IMPROVE PHASE. In this issue, I will share with you how to use Control Lot and Testing and Pilot the Action / Solution in

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

carry out this TQM project using the D.A.I.C. Methodology as described in my previous article.

Just to recap, tools used in the IMPROVE Phase are listed below. I will deal with tools that ar

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

Examples of combination products may in

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

r

How to use Control Lot and Testing

This tool is particularly useful to verify if the corrective action / solution is able to meet the team's objective. It is also used to confirm certain control

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

parameter of changes in process. If the control lot is to verify process capability, then the parameter of this control lot must meet the desire process capability as well.

Let’s see how to do it. In a coa

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

Combination pro

ing line, the team has decided to change the belt speed of a conveyor line but not sure what level of speed is most optimized to obtain the best coating thickness control. A control lot in this case will 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

run with various speed adjusted manually. At each speed, the coating thickness is recorded. At the end of the control lot / testing, a correlation is done to verify which speed yield the most optimum coat

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

ng thickness. All these test is done in a controlled environment.

Once the control lot is satisfied, record the optimized belt speed, them the team is ready for a larger lot in full production mode and so

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

e controlled environment.

Pilot the solution

Pilot run is a common practice for a new product resting. For this D.A.I.C. Methodology, we use it to double sure changes to the production parameters

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

re well implemented. The objective if this tool is to implement the optimized belt speed during full production run. However, the volume of run is much lesser and more attention is given to ensure the new

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

peed is communicated and set for the pilot production run.

As the production lot for the pilot run is more compared to a control lot, care should be given to ensure all new belt speed is set accordingly. D

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

Following aspects would a

e to the fact that this is like a full production run, team need to put extra attention to any drastic changes to other production parameters. During the pilot run, team would record the effect of the pilot

dd to the challenges in developing combination products:

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

run in terms of coating thickness and other quality specifications. Once it is confirmed, it is considered as successful.

In summary, this IMPROVE PHASE Control lot and testing and Pilot t

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

e action / solution would be critical to prevent any unwanted element occurred when a solution is put in placed for production. This is the “hardware” of the solution. In most case, it can be tested and

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

adjusted until satisfactory. However, this alone does not guarantee the success of the improvement project. The human factor or the "software” within the process must be addressed in order to ensure full im

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

lementation of the proposed solution. In my next article, I will share with you how this can be accomplished with the last two tools of the IMPROVE PHASE i.e. Force-Field Analysis and Prevention Pla

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

Professional from academic institutions, pharmaceutical industries, health care indust

ner

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Disclaimer All rights reserved. This article is written by the author based on his practical application experience. All defini

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

ions and interpretation of terminology are his point of view and has it has no intention to conflict with experts in similar topic. The author holds no responsibility for the use of this article in any way.

.

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

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Free to reprint or re-publish All rights reserved. You are free to reprint or re-publish this article as long as you include my re

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

Companies that provide selfless information through particip

ource 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.

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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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Knowing the differences in managerial practices in different countries is interesting. There are, for example, great differences among mangers in the United States as opposed to other countries. With the increasing investment of foreign firms in the United States, the syllabus of business finance is giving more attention to the integration of managers and workers from other countries into American society. This need is highlighted in that the number of inters company transferees has more than tripled from the late 1970’s. The Japanese, for example, often find it difficult to be outspoken and direct in interactions with their colleagues and superiors. People from Arabian countries usually find American teaching methods too impersonal. One can learn various approaches used by the managers to reduce culture shock. These include special programs about corporate life in the US, as well as instruction in English, books and movies and tax advice for newcomers.

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