Monday, July 20, 2009

Pharmaceuticals regulatory affairs

Pharmaceuticals manufacturing there for is very serious business , this is regulated by number of laws , in USA it is regulated by US FDA , this is a regulatory body which keeps vigil on each and every company which is importing and exporting medicines to USA and abroad and any company which is exporting medicine to USA.

All medicines are required to comply with the standards in pharmacopoeia.

All medicines are tested well before they are distributed to general public

All medicines are tested for its side effects in clinical trials before it is approved for use in human beings.

This process is very lengthy , starts from clinical trials to final licencing to manufacturing registration and all ,this is called regulatory affairs for pharmaceuticals

Apart from this all process in pharmaceuticals manufacturing is well documented ,well evaluated and validated.

There is great value for validations of each and every step in pharmaceuticals manufacturing.

There is great value for documentation of all steps happening during manufacturing.

Pharmaceuticals manufacturing required to comply with WHO cgmp guidelines for pharmaceuticals.

To pursue the carrier in this field one has to go through very strict training and cource to becoming a pharmacist .

Pharmacists role is very wast ,

He is a key person in developing and designing new drug molecules

Testing them for safety

Formulating the drug for effective use on human being , effective utilisation of dosage forms , and bioavailability of dosage forms like tablets

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