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.

What is the difference between controlled copy and un-controlled copy?

Controlled copy: A controlled copy is a formal copy of the latest, correct issue of a document; an identified issue of a document to an individual or location of the record. The controlled copy is officially tracked, updated & destroyed to assure that it is current.

Uncontrolled copy: An informal copy of a document for which no attempt is made to update if after distribution; the document is marked “uncontrolled” and the user determines if the document is active prior to use. Controlled and uncontrolled copies of the documents are issued by the quality assurance department as per the official requirements. Uncontrolled copies are unofficial copies of documents generally, issued for review purpose.