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Digg It - Electronic Date Stamps
Manual date stamps are adequate for marking date in years and months. However using manua
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
l date stamps for marking date in months, days, hours, and minutes is problematic. Furthe
; 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
r, manual date stamps require rotation of bands and pre-checking of the positioned date o
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
n a waste paper. This is necessary because embossed numbers do not resemble normal number
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s. Electronic date stamps are designed to overcome such drawbacks.
Electronic date stamp
Electronic date stamp
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
s comprise of electronic control unit, interface connector and date stamps. Date stamps c
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
ome with choice of year, month, day, hour, and five-minute intervals. Date stamps are con
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
nected with an interface connector, which in turn is connected to an electronic control u
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nit that enables programming of the date stamps. Electronic date stamps can also be netwo
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
rked with production machinery for facilitating effective monitoring. Access to electroni
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
c date stamps can be restricted by password protecting the controller. Additional dies fo
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
r printing custom text such as “QC Checked”, “Processed”, and “Defective” can also be add
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
ed to electronic date stamps.
Electronic date stamps are also highly useful in automated
Electronic date stamps are also highly useful in automated
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
production environments where products need to be marked for getting traced. Electronic
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
date stamps can be incorporated with in the production environment for automated marking
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
without stopping the process.
Often in large factories deep cavity molds or extra large
Often in large factories deep cavity molds or extra large
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
molds are unreachable from floor. Changing of date stamps wastes precious labor time unde
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r such scenarios. Factories have to resort to expensive date marking processes such as la
.
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
ser etching or inkjet printing for marking parts that difficult to reach and mark through
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
manual stamps. Electronic date stamps provide a cost effective solution to this problem.
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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