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Sunday, August 1, 2010

US FDA'S initiative to control inapropriate use of antimicrobial agents in food producing animals

US FDA'S initiative to control inappropriate use of antimicrobial agents in food producing animals

There is news which you will like to read , apart from the magic mineral water issue, where US FDA has asked Dairy Farms to not to use antibacterial agents inappropriately in food-producing animals , US FDA found the drug residues in samples of tissues ,containing residues of antibiotics such as neomycin, flunixin, desfuroylceftiofur, and sulfamethazine beyond permitted levels FDA found that the it is not safe for humans .
These drugs were being used to promote weight gain in animals rather than treating animals before slaughtering.
The US FDA approves any new animal drugs with requirements, which includes a specified time period withdraw an animal from treatment prior to slaughter, to ensure that a drug has been depleted from edible tissue to a level safe for humans.
In the response to this initiative of US FDA dairy farms in USA has agreed to stop Improper medication to animals.FDA has asked them comply with all requirements. which includes establishment of a recordkeeping system approved by the FDA to track the identity of medicated animals and the drugs and dosages given.

US FDA has also published a guidance document for use of antimicrobial agents in food-producing animals.
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Antibiotic resitance and Antibiotic resistance mechanism

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

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

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 coefficient 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

Controlling 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

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

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

Here are some interesting articles on Quality assurance systems for pharmaceutical company

1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industryan explanation

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