Standard Operating Procedure for

Title
Controlling Temperature and Relative Humidity
Version SOP# Effective Date Page
0 QAM-016 30-0ct-2018 1 of 6

Prepared By: ____________________________________________________________

Sajid-ur-Rehman (Q.A.I)
Date: ________________

Reviewed By: ____________________________________________________________

Khalil Hussain (Senior Microbiologist)
Date: ________________

Reviewed By: ____________________________________________________________

Narmida Shumail (Production Pharmacist)
Date: ________________

Approved By: ____________________________________________________________

Khalid Rehman Khattak (Plant Manager)
Date: ________________

This is either a new SOP or an essentially complete re-write; all sections were
affected.

Do revisions require additional

Yes No
training:
 Standard Operating Procedure for
Title
Controlling Temperature and Relative Humidity
Version SOP# Effective Date Page
0 QAM-016 30-0ct-2018 2 of 6

1 Title
Standard operating procedure of Temperature and Humidity Control

2 Objective
The purpose of this SOP is to define Temperature and Humidity Control in
Agror Pharmaceuticals.

3 Scope
It is applicable to all departments in Agror Pharmaceuticals. (Sections of
Production, warehouse, QC Lab. and Micro Lab.

4 Responsibility
 Plant Manager, To approve the following procedure and availability of
relevant resources.
 Production Manager, To follow the following procedure.
 Quality Assurance Manager, To implement the following procedure.
 Quality Assurance Officer, To follow and assure the implementation of
following procedure.
 In charge Pharmacist, To follow and implement the following
procedure.

5. Abbreviation(s)
5.1 SOP Standard Operating Procedure
5.2 QC Quality Control
5.3 NMT Not More Then
5.4 QA Quality Assurance
5.5 PMS Packaging Material Store
5.6 RMS Raw Material Store
5.7 RH Relative Humidity
 Standard Operating Procedure for
Title
Controlling Temperature and Relative Humidity
Version SOP# Effective Date Page
0 QAM-016 30-0ct-2018 3 of 6

6.0 TEMPERATURE AND HUMIDITY LIMITS

 A chart of controlled environmental conditions is as follow

Section Area Temperature Relative Humidity

Dry Injectable Section

Filling room 23 ºC ± 2 ºC NMT 40%

Packing hall 23 ºC ± 2 ºC NMT 50 %
Dry Suspension Section

Mixing Room 23 ºC ± 2 ºC NMT 40 %

Filling Room 23 ºC ± 2 ºC NMT 40 %
Packing Hall 23 ºC ± 2 ºC NMT 50 %

Ceph. Capsule Section

Capsule Mixing 23 ºC ± 2 ºC NMT 45 %

Capsule Filling 23 ºC ± 2 ºC NMT 45 %
Blistering 23 ºC ± 2 ºC NMT 50 %
Packaging 23 ºC ± 2 ºC NMT 50 %
Warehouse (RMS and PMS)

Raw Material store 23 ºC ± 2 ºC NMT 50 %

Dispensing Room 23 ºC ± 2 ºC NMT 40 %
Sampling Room 23 ºC ± 2 ºC NMT 40 %
PMS 23 ºC ± 2 ºC NMT 50 %
Quality Control Department

Retained Samples Area 23 ºC ± 2 ºC NMT 50 %

Instrument Room 23 ºC ± 2 ºC NMT 50 %
Micro Lab 23 ºC ± 2 ºC NMT 50 %
 Standard Operating Procedure for
Title
Controlling Temperature and Relative Humidity
Version SOP# Effective Date Page
0 QAM-016 30-0ct-2018 4 of 6

7.0 PROCEDURE
6.1.1 In order to obtain maximum and minimum temperature or humidity, press buttons
on Digital hygrometer for maximum / minimum temperature and humidity.

6.1.2 Quality assurance inspector and section Incharge/pharmacist checks the

temperature and humidity daily and note it in each respective file

8.0 TRAINING
8.1 PERIODICAL TRAINING:

The QAI is responsible for performance of this operating instruction has to be

demonstrated periodically about the content of this SOP.

8.2 TRAINING FOR NEW EMPLOYEES:

Before starting with the job, the employee has to be demonstrated about the content of
this SOP.

9.0 LIST OF COPY HOLDERS

Issued To Issued on Withdrawn on (Date/Signature)
(Date/Signature)

Quality Assurance Manager

Quality Control Manager.

Production Manager

Quality Assurance Inspector

 Standard Operating Procedure for
Title
Controlling Temperature and Relative Humidity
Version SOP# Effective Date Page
0 QAM-016 30-0ct-2018 5 of 6

10.0 Revisions

Specify the sections that were affected by the update and briefly describe the change.

Revision # Effective Section Description of Change

Date
 Standard Operating Procedure for
Title
Controlling Temperature and Relative Humidity
Version SOP# Effective Date Page

0 QAM-016 30-0ct-2018 6 of 6

Temperature And Relative Humidity Temperature: 230C+020C

Section :_________________ R.H.% :______________
Date Time Temp R.H Time Temp R.H Time Temp R.H Performed Checked by
by