Company Name:: Version No.

1
Title:
Document No:
SOP/WH/010
SOP for Recording of Temperature and Humidity in Page No.
Page 1 of 3
Stores Department
Effective Date Revision Date

SOP for Recording of Temperature and Humidity in Stores

Department

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date

1. Purpose
 Company Name:: Version No.
1
Title:
Document No:
SOP/WH/010
SOP for Recording of Temperature and Humidity in Page No.
Page 2 of 3
Stores Department
Effective Date Revision Date

The purpose of this SOP is down a procedure for procedure for recording of Temperature &
Humidity in Stores Department

2. Scope

This procedure shall be applicable for Dispensing Room, Sampling Room, RM Store, Foil
Store, PM Store, BSR & Cold Storage at Stores Department in

Validity

This SOP is valid only until next revision date and if it bears control seal.

3. Responsibility

It will be the responsibility of Stores Officer/Assistant. Quality assurance manager is

responsible for SOP compliance.

4. Material and Equipment

None
6. Procedure

6.1. Store person shall ensure that all the air conditioners and AHU’s of the respective store
area are “ON”.
6.2. Store person shall note down the temperature & humidity twice in a day for Dispensing
Room, Sampling Room & RM Store.
6.3. Store person shall note down the temperature twice in a day for RM Store, Foil Store,
PM Store, Bonded Store Room and Cold Storage.
6.4. Specific time for noting temperature shall be 8.00 to 9.30 am & 12.00 to 13.30 pm Hrs
6.5. If any abnormalities are observed during the recording, store person shall inform to Store
Head.
 Company Name:: Version No.
1
Title:
Document No:
SOP/WH/010
SOP for Recording of Temperature and Humidity in Page No.
Page 3 of 3
Stores Department
Effective Date Revision Date

6.6. Store Head in turn shall inform the observed abnormalities to HOD QA & QC, Unit
Head and Engineering Head for further rectification and action.

NOTE: Temperature and relative humidity is important from the point of view of
• To avoid degradation of products.
• To avoid damage to hard gelatin capsule shells.
• Ensure the thermometer / temperature indicator is calibrated.
Related: Principle of Hygrometer and Its Use in Pharmaceuticals
Acceptance Criteria for Temperature & Humidity
• Dispensing Room : Temp. NMT 25°C & Humidity NMT 55 ±5%
• Sampling Room : Temp. NMT 25°C & Humidity NMT 55 ±5%
• RM Store : Temp. NMT 25°C & Humidity NMT 55 ±5%
• Foil Store : Temperature NMT 25°C
• PM Store : Temperature NMT 30°C
• BSR : Temperature NMT 25°C
• Cold Store : Temperature between 2°C to 8°C

7. Abbreviation
SOP - Standard Operating Procedure
GRN - Goods Receipt Note
8. Related Documents /Applicable document/
None
9. Revision History

Version
Revision Description
No.

1 New