SOP for Recording of Temperature and Humidity in Raw Material Store : Pharmaceutical Guidelines

SOP for Recording of Temperature and Humidity in Raw Material Store

Standard operating procedure to record the temperature in Raw Material and Packing Material Store for maintaining proper storage conditions.

1.0 OBJECTIVE

To lay down a procedure for recording of Temperature and Humidity in Raw Material Store and temperature recording in Packing Material Store for maintaining proper storage conditions.

2.0 SCOPE

This SOP shall be applicable to maintain storage condition in RM & PM 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 of the respective store areas switch “ON”.
5.2 Store person shall note down the temp & humidity twice in a day for the raw material store and temperature in Cold Room. The specific time for noting temperature shall be 8.00 to 9.30 am & 12.00 to 13.30 Hrs.
5.3 Store person shall note down the temp twice in a day for packing material store. The specific time for noting temperature shall be 8.00 to 9.30 am & 12.00 to 13.30 Hrs.
5.4 If any abnormalities are observed during the recording, store person shall inform to store Head.
5.5 Store Head, in turn, shall inform the observed abnormalities to QA head, Plant 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 ensure comfortable and hygienic working of workmen as per GMP norms.
• To avoid damage to hard gelatin capsule shells.
• Ensure the thermometer/ temperature indicator is calibrated.
• Room Temperature: The temperature prevailing in a working area.
• Cool: The temperature between 8°C to 25°C.
• Cold: The temperature between 8°C to 15°C.
• Deep Freezer: The temperature between 2°C to 8°C.
• Humidity: NMT 55 ±5%

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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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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