The quality of products manufactured in a pharmaceutical company depends on the environmental conditions provided during it’s manufacturing. Pharmaceutical products are highly sensitive to the temperature and humidity of the premise where they are being manufactured or stored. Most of the ingredients and excipients used in the manufacturing process are hygroscopic in nature those can change their physical and chemical properties on exposure to adverse environmental conditions. Therefore, it is very essential to maintain environmental conditions in the acceptance criteria. A properly written document is required to follow for environment conditions monitoring, to meet the objective a valid SOP for Environment Monitoring is required.

PURPOSE: To establish a practical working procedure for Environment Monitoring.

RESPONSIBILITY: Q/C Manager.

ACCOUNTABILITY: Production Manager

SCOPE: The procedure of this SOP shall be applicable to the Production Department of Digital Vision Kala Amb.

PROCEDURE:

Record the temperature & humidity in the environment monitoring chart.

Regulate the A/C of the Dehumidifier if the temperature of a particular area is out of the prescribed limit.

The limit is specified below:

PRODUCTION AREA:

Area Temperature Humidity

Mixing Granulation & Drying 28-29^OC 70% Max.

Blending, Compression 25-27^OC 40-45%

Capsulation, Powder, Dry Syrup 23-25^OC 40-45%

Beta-Lactum Capsules, Tablets 23-27^OC 40-45%

Film Coating 25-27^OC 50-55%

Corridors 25-27^OC 70% Max

STORE AREA :

AREA TEMP RH

  Beta Lactum                                       25-27^OC         50% Max
  Capsules & Sensitive
Materials         25-27^OC         50% Max
Other products                                     30^OC               70%
Max

LABORATORY AREA:

AREA TEMP. RH.

Instrument room
& Microbiology room 25-27^OC 50% Max

Chemical Laboratory 28-30^OC 70% Max

Quarantine & Control
Sample Room 25-27^OC 50%
Max

Liquid Mfg. & Bottle
Washing 28-29^OC 70%
Max

Ointment & Lotions 25-27^OC 50-55%