E-Articles - Computers and Technology

Manufacturing control software has existed in a rudimentary form since the advent of Computer Numerica

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 Control (CNC) machines. The term CNC refers to the computerized control of machine tools, to facilit

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

Examples of combination products may in

te the repeated production of complex parts in all kinds of materials. CNC was developed in the late

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

1940s and early 1950s in the M.I.T.

Early CNC machines used a software program written in a notation

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

called G-Code. In the early days, the computers were very large in size and were power guzzlers. Despi

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

Combination pro

e their huge presence, the 1950 computers had very limited processing or data storage power. Therefore

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

, computers were not used in the manufacturing industry, till the appearance of Personal Computers (PC

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 suitable Operating Systems in the 1980s.

With The PC explosion in the 1980s, CNC manufacturers

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

started shifting to PC-based controls running Microsoft Windows or O/S 2 operating systems, which can

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

e linked to the existing networks using standard protocols. Manufacturing companies began to move away

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

from, expensive minicomputer and workstation based CAD/CAM which usually ran on G-Code, towards the mo

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

Following aspects would a

re cost-effective PC-based software solutions. PC-based systems which can accomplish complicated tasks

dd to the challenges in developing combination products:

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

using standard network protocols are available at minimal or no cost. In most cases, the Manufacturer

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

s do not need an 'expert' to implement shop floor networking, and can do the implementation themselves

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

The demand for sophisticated manufacturing software has grown tremendously, over the last fifteen ye

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

rs and affords a lot of new and exciting functionality, to a variety of machines in the manufacturing

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

Professional from academic institutions, pharmaceutical industries, health care indust

industry.

Many software developers write and provide proprietary software systems. These are for manu

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

acturing companies, employing computer control of machine tools such as milling machines, cutting mach

.

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

ines, robots, hexapods, and lathes. However, these software programs are supplied for a fee, and are s

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

Companies that provide selfless information through particip

bject to Copyright Act provisions. Free open source CNC control software is also available on Internet

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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