What is Common Technical Document(CTD)in pharmaceutical industry:
Common Technical Document (CTD) is a document of requirements for a pharmaceutical product dossier for application for registration of medicines and It is used for registration in Europe, Japan and USA .
It is designed and formed by
1.The European Medicines Agency (EMEA, Europe),
2.The Food and Drug Administration (FDA, U.S.)
3.The Ministry of Health, Labour and Welfare (Japan).
The CTD for a product is also maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The Common Technical Document is consists of following 5 Modules :
1.Administrative and prescribing information
2.Overview and summary of modules 3 to 5
3.Quality (pharmaceutical documentation)
4.Safety (toxicology studies)
5.Efficacy (clinical studies)
The technical information in Module one and some subheadings of other Modules vary, with different country and their requirements.
In following countries and regions CTD is adopted
1.United States of America
2.European Union
3. Japan
4. Canada
5. Switzerland.
Several other countries are also adapting Common Technical Document (CTD).
What is eCTD ?
Electronic Common Technical Document.
Electronic equivalent of CTD is the eCTD there is an interface provided on regulatory agencies or FDA’s website to submit CTD in a electronic format , as it is easy for pharmaceutical companies and FDA or regulatory agency to receive transfer and save and process regulatory information, Common Technical Document for a particular Drug or pharmaceutical . The content and format in eCTD more or less similar to non electronic version of Common Technical Document (CTD).
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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
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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
Common Technical Document (CTD) is a document of requirements for a pharmaceutical product dossier for application for registration of medicines and It is used for registration in Europe, Japan and USA .
It is designed and formed by
1.The European Medicines Agency (EMEA, Europe),
2.The Food and Drug Administration (FDA, U.S.)
3.The Ministry of Health, Labour and Welfare (Japan).
The CTD for a product is also maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The Common Technical Document is consists of following 5 Modules :
1.Administrative and prescribing information
2.Overview and summary of modules 3 to 5
3.Quality (pharmaceutical documentation)
4.Safety (toxicology studies)
5.Efficacy (clinical studies)
The technical information in Module one and some subheadings of other Modules vary, with different country and their requirements.
In following countries and regions CTD is adopted
1.United States of America
2.European Union
3. Japan
4. Canada
5. Switzerland.
Several other countries are also adapting Common Technical Document (CTD).
What is eCTD ?
Electronic Common Technical Document.
Electronic equivalent of CTD is the eCTD there is an interface provided on regulatory agencies or FDA’s website to submit CTD in a electronic format , as it is easy for pharmaceutical companies and FDA or regulatory agency to receive transfer and save and process regulatory information, Common Technical Document for a particular Drug or pharmaceutical . The content and format in eCTD more or less similar to non electronic version of Common Technical Document (CTD).
--------------------------------------------------------------------------------------------------------
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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