Saturday, 22 December 2018

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.


What is commissioning?


Commissioning is an engineering term that covers all aspects of bringing a system /sub-system to a position where it is regarded as being ready for use in pharmaceutical manufacture. Commissioning involves all the basic requirements of Installation qualification (IQ) & Operational Qualification (OQ).

In simple words, commissioning is the process to start a system from its initial stage to the working stage where the system is ready to work.

requirement of Q.C in Daman

  We have requirement of Q.C Working area : Daman/Dalwada Exp: Fresher Gender: Male Qualification: Any Graduated Interested Person Call On t...