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Overview

Compound purification is one of the key activities in the Chemical and Medical industry. A typical purification process involves

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

the following procedures;

Accepting crude samples
Dilution and duplication
Prepare for instruments
Analysis using instru

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

Examples of combination products may in

ments

Quality check

Store the purified compound

In any of the above procedure a rework or scrap of the sample is allowed. Apart fr

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

m the above procedures various kinds of reports can be generated for the audit. Selection of software to support the compound purification is a troublesome

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

job. Many organizations are going for developing new system, which is not only time consuming but also expensive.

Correlating the compound puri

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

Combination pro

ication procedures with Manufacturing Execution Systems (MES) works flow.

The compound purification process resembles a manufacturing system in m

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

any ways. A manufacturing system accepts the row material's information from the Material Control System or from the ERP. Accepting the crude samples can b

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

e considered as a similar activity.

Dilution and duplication is similar to a workstation in MES. In a typical purification process dilution and duplicatio

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

is conducted using various instruments or by hand.

Prepare for instruments can be considered as a data capturing screen in MES. Various instruments relat

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

ed information and data related to the solvent and solution and aliquot can be captured in this step.

MES is well known for controlling and monitoring ins

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

ruments. Analysis using instruments is nothing but integrating the instrument protocols with the MES.

MES provides lots of quality check options including

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

Following aspects would a

the Corrective and Preventive activities. Quality check is inbuilt in almost all available MES in the market.

MES is always having at least one module fo

dd to the challenges in developing combination products:

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

r dispatch items or stock. Storing the purified compounds can easily be handled by any MES.

Additional advantages provided by MES MES i

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

widely advertised as paperless. This integrated solution improves operational efficiencies while ensuring regulatory compliance and the highest levels of

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

quality.

Improve quality while reducing cost of quality
Improve global operational efficiencies
Reduce cost of regulatory compli

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

nce and minimize the impact of recalls

Accelerate time-to-deliver purified compounds

Implement Six Sigma and lean initiatives

Red

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

Professional from academic institutions, pharmaceutical industries, health care indust

uce purification cycle times and crude inventory

Improve compound receiver service

Share real-time data on quality and crude status with

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

the Work in Progress information.In addition to the above MES enforces compound purification processes along the purification onramp, eliminating

.

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

mistakes before they can occur. By systematically applying purification rules, organizations eliminate operator guesswork and ensure that operators adhere

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

Companies that provide selfless information through particip

to consistent purification processes.

Conclusion

Manufacturing Execution System is the best fit for any compound purification management

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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In our last 2 installments of this series, we explored the foundation of building a practice on purpose -- knowing with crystal clarity your true purpose. Let's assume that you've done the work to clarify your purpose. How do you connect your purpose to your practice? By creating a vision statement for your practice that incorporates your life purpose.

I've learned that when a person starts thinking about telling their life story, they tend to overthink it. They get caught up in worrying about things such as what others will think and who would publish it.

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