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Importance of Batch number in Pharmaceuticals

What is a Batch?

According to US FDA a batch is a specific quantity of an intermediate or API required having a uniform character and quality. This quantity should be in specified limits and must be produced during same cycle of manufacture. In other sense, a batch may be a specified quantity of material or API processed in one or more processes so that it becomes homogeneous.

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Anjum Rehman's picture
Author: Anjum Rehman

I am an experienced Pharmacist and MBA.

Why Regulation of Drugs is required?

Why Regulation of Drugs is required?

A Drug is a specific substance recognized and located by an official Pharmacopeia and Formulary, and used for cure, treatment, diagnose and prevention of disorder or disease.

Drug is a substance (excluding food) that that exert changes about structure and any function of the body.

About the Author

Anjum Rehman's picture
Author: Anjum Rehman

I am an experienced Pharmacist and MBA.

Pharmaceutical sciences: 

Drug Master File

Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted to the appropriate regulatory authority in the intended drug market. DMF is a document containing complete information on an Active Pharmaceutical Ingredient (API) / drug substance, intermediate of drug substance, packaging material, excipient or drug product.

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Amol Malpani's picture
Author: Amol Malpani

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