SOP for Recording of Temperature and Humidity in Stores Department

1.0 OBJECTIVE

To lay down a procedure for recording of Temperature & Humidity in Stores Department.

2.0 SCOPE

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

3.0 RESPONSIBILITY

Stores Officer/Assistant

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Store person shall ensure that all the air conditioners and AHU’s of the respective store area are “ON”.
5.2 Store person shall note down the temperature & humidity twice in a day for Dispensing Room, Sampling Room & RM Store.
5.3 Store person shall note down the temperature twice in a day for RM Store, Foil Store, PM Store, Bonded Store Room and Cold Storage.
5.4 Specific time for noting temperature shall be 8.00 to 9.30 am & 12.00 to 13.30 pm Hrs
5.5 If any abnormalities are observed during the recording, store person shall inform to Store Head.
5.6 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

6.0 ABBREVIATIONS

6.1 SOP – Standard operating procedure
6.2 NMT – Not more than
6.3 QA – Quality assurance
6.4 RM – Raw material
6.5 PM – Packing material

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