Standard Operating Procedure For Environment Monitoring

by Pharmadocx Consultants

PURPOSE:   To lay down a method for environment monitoring.

SCOPE: This procedure applies for an entire unit.

RESPONSIBILITY  : Production, Q.C and Store supervisor.


1.   Record the temperature & humidity in the environmental monitoring chart.

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


3.  The limit is specified below:

Injection Washing25-27°C50%max
Injection area25-27°C (class1000)50%max
Dry Injection23-25°C35-40%
  • Record the result in the following format
DateArea                        Time                       Limit                      ObservationRemarks
Author: (GM Production)Checked by: (QA Manager)Authorised by: (Director Technical)
Date:Date :Date :

(Review date on or before 12 months from date of authorization)

Written by Anmol Singh

Anmol Singh Completed his Bachelors in Field of Mechanical and Automation Engineering. He has over 2 Years of experience in field of Pharmaceuticals, Medical Devices, Cosmetics Manufacturing.

12 June 2023

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