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Friday, June 4, 2010

ICH International Conference on Harmonisation

What is (ICH) or International Conference on Harmonisation (ICH) what is its role in pharmaceutical industry?
The International Conference on Harmonisation (ICH):
The International Conference on Harmonisation is a common body or organization of regulatory authorities of Europe, Japan and the United States and pharmaceutical industry representatives or experts from these three regions of they discuss and help each other in forming and implementing technical requirements for registration of pharmaceuticals for human use and harmonizing between FDA’S or regulatory authorities in these region and Pharmaceutical companies
The International Conference on Harmonisation (ICH) is a project that brings together pharmaceutical companies and FDA’S or regulatory authorities of Europe, Japan and the United States and help each other to discuss , form , and implement scientific and technical aspects of pharmaceutical product registration.

The International Conference on Harmonization (ICH) recommend and harmonize or help in the interpretation and purpose of technical guidelines and requirements for product registration.
This prevent or reduce duplication of work and the testing carried out during the research and development of new medicines by ways to achieve greater.
This helps in efficient and economical use resources of human, animal and material, and reduces needless hindrance availability of new drugs and in the global development without compromising regulatory obligations and safeguards of quality, safety, and efficacy, and to protect public health.

ICH guidelines are adopted as law in several countries, where as they are used only as a guidance for Pharmaceutical industry in US, the pharmaceutical companies in USA are regulated by US FDA regulations.

Following regulatory bodies and pharmaceutical industry organizations, founding members are responsible for the decision making process:
1.The European Commission,
2.The European Federation of Pharmaceutical Industries and Associations (EFPIA),
3.The Ministry of Health, Labour and Welfare,
4.The Japan Pharmaceutical Manufacturers Association (JPMA)
5.The Food and Drug Administration (FDA),
6.The Pharmaceutical Research and Manufacturers of America (PhRMA)

What is What is 510(k) Clearances ?
What is 510(k) Clearances, Premarket Notification for medical devices - PMN or 510(k)

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing


Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coeeficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Eletronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an intresting article on world wide pharmaceutical industry
Article on Pharmaceutical Industry pharmaceutical industry

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