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Advice You - Documentation and Audit problem Case Study - How to Overcome in TQM Impelmentation Project Part 8b
This TQM article is Part 8b issue, it is a continuation of Part 8a published on [May 17, 2117 19:47:31 am]. This issue will deal with some of the problems as
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
sociated with the CONTROL Phase of the D.I.A.C. Improvement Methodology and how they can be overcome.
In this issue, I will share with you some of the probl
In this issue, I will share with you some of the probl
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
em with Documentation and Audit and how they were overcome by the team leader.
Case study on Documentation
A team member presented a procedure for a solution established during the improvement project. It was noted that the new work procedure was clearly indicat
Case study on Documentation
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
A team member presented a procedure for a solution established during the improvement project. It was noted that the new work procedure was clearly indicat
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ed however several other pertinent items were omitted. It was discovered that the standard procedure format was not used.
How Documentation problem
How Documentation problem
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
as overcome
The team member was asked to filled up all the information in the used the standard procedure format. Hence, all pertinent items were i
The team member was asked to filled up all the information in the used the standard procedure format. Hence, all pertinent items were i
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
ncluded.
Case study on Audit
Team member was assigned to audit the implementation of several solutions which was derived
Case study on Audit
Team member was assigned to audit the implementation of several solutions which was derived
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
and agreed during the progress of the improvement project. As usual, an audit report was presented during a project progress meeting. Below are some sample o
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
f the audit progress report:-
Audit question 1: Did the worker comply with the new work procedure?
Report findings 1 : Yes
Audit question 2: What is the r
Audit question 1: Did the worker comply with the new work procedure?
Report findings 1 : Yes
Audit question 2: What is the r
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
sult of the new work procedure in terms of reject rate?
Report findings 2: Normal
What do you think about the Audit Findings? Looks alright to you? but it
Report findings 2: Normal
What do you think about the Audit Findings? Looks alright to you? but it
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
does not indicate what was the reject rate, correct?
How Audit problem was overcome
One of the common Audit problems is often Audit Report
How Audit problem was overcome
One of the common Audit problems is often Audit Report
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
Findings is ambiguous. To overcome this ambiguity problem, we did the following remedies:-
- the auditor should state the material facts of his audit
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
findings. Example: the reject rate was 3.2% in 2nd shift on 22 May 2007. Provide auditor briefing to ensure expectations are clearly understood.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
>Assign auditor from other department or area of work.
In summary, Documentation and Audit tools are quite
In summary, Documentation and Audit tools are quite
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
imple but may be easily neglected. These two tools are needed to ascertain the sustainability of the improvement results.
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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
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
------------------------------
Disclaimer: This article is written by the author based on his practical application experience. All definit
Disclaimer: This article is written by the author based on his practical application experience. All definit
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ons 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 respon
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
sibility for the use of this article in any way.
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Free to reprint or re-publish
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Free to reprint or re-publish
.
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
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
rong>: All rights reserved. You are free to reprint or re-publish this article as long as you include my resource box at the end of this article. Please ensu
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
re 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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