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Advice You - Why Quality Assurance is Not Enough
How can a company produce zero-defect products, boast dramatic cycle-time reductions, be certified fo
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
r consistent, reliable performance...and still lose valuable customers?
Doesn’t the systematic effor
Doesn’t the systematic effor
; 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
t to reduce waste, improve yields and streamline processes lead to better service, higher profits and
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
more loyal customers?
The answer is ‘not necessarily’. Here’s why:
Quality Assurance (QA) efforts
The answer is ‘not necessarily’. Here’s why:
Quality Assurance (QA) efforts
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
uch as ISO Certification, Six Sigma Quality Control and 10X Cycle-Time Reduction can lead to greater
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
consistency, lower costs and higher speed. But these programs alone will not keep your finger on the
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
ever-changing pulse of your customers’ interests, hopes, needs, fears and feelings.
QA leads to grea
QA leads to grea
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
ter predictability and higher standards. That’s important!
But customers are human. And humans are i
But customers are human. And humans are i
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
trigued by creativity, appreciation, personal touch, extra-mile efforts and surprise. That’s importan
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
t, too.
To win with customers in today’s competitive world, you need both.
You’ve got to work on bo
To win with customers in today’s competitive world, you need both.
You’ve got to work on bo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
th continuously. You’ve got to be on time, and turned on. You’ve got to be accurate, and passionate.
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
You’ve got to meet standards, and exceed expectations. You’ve got to please your customer, and someti
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
es tease your customer.
Key Learning Point
You must always improve your systems, methods, standards
Key Learning Point
You must always improve your systems, methods, standards
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
and procedures. But you must also cultivate the human qualities of intimacy, connection, caring, per
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
sonality and style. Yes, squeeze those defects out the door, but keep the window open! Let your human
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
ity come shining in.
Action Steps
Review the active improvement efforts at your organization. You s
Action Steps
Review the active improvement efforts at your organization. You s
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
ould have ongoing QA programs featuring hard statistics, real experiments and rigorous workflow mappi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ng. At the same time, you must have ‘soft skills’ programs to improve listening, personal communicati
.
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
on, cultural respect, ethics, responsibility, recovery, service mindset and customer delight. Make su
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 you have a healthy mix of both for the success of your business, your employees and your customers
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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