SOP for Recording of Temperature and Humidity in Stores Department : Pharmaceutical Guidelines

SOP for Recording of Temperature and Humidity in Stores Department

Standard operating procedure to record the 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 then
6.3  QA – Quality assurance
6.4  RM – Raw material
6.5  PM – Packing material





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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