What are the types of DMF?

Drug master files are regulatory submission requirements.

There are four types of DMF. They are referred to by their numbers in Roman numerals:

Type-I: Is an obsolete number once used for a category that no longer exists because it was found to easily fit into and overlap with the other four categories.

 Type-II: DMF is for companies who supply drug substances, drug products, intermediates & material used in their manufacture.

Type-III: DMF is for companies who supply packaging (container closure system) for human drugs & biologics.

Type-IV: DMF is for companies who supply excipients

Type-V: DMF is for companies who supply clinical services, sterile manufacturing etc.

What is a DMF?

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

A DMF is a package of proprietary information filed voluntarily by a company with the FDA. If it held by them in confidential closed files until such time as an FDA reviewer requests a review of the DMF.

What are the different climate zones in the world?

Different zones of the world have different climatic conditions. The world is divided into the five climate zones and is given :

Zone	Name	Conditions
I	Temperate	21° C / 45% RH
II	Subtropical & Mediterranean	25° C / 60% RH
III	Hot & Dry	30° C / 35% RH
IV A	Hot & Humid	30° C / 65% RH
VB	Hot & Very Humid	30° C / 75% RH

What are the advantages of Rinse sampling?

Rinse samples are taken during the cleaning of the equipment. A large surface area of the equipment can be sampled using this technique.

Following are some advantages of rinse sampling.

• ·         Adaptable to online monitoring
• ·         Easy to sample
• ·          Non-intrusive
• ·          Less technique dependent that swab
• ·         Applicable for active, cleaning agents & excipients allow sampling of large surfaces
• ·         Allows sampling of unique (e.g. porous) surface.

What are the advantages of Swab sampling?

Swab samples are taken from equipment as well as other areas. It is useful to take a sample of sticky material.

 Following are some advantages of this sampling technique.

• ·         Dissolves & physically removes a sample
• ·         Adaptable to a wide variety of surfaces
• ·         Economical & widely available
• ·         May allow sampling of a defined area
• ·         Applicable to active, microbial & cleaning agent residues.