1. OBJECTIVE
To provide a proper procedure recording of Temperature and Humidity in production areas for maintaining proper manufacturing conditions
2. SCOPE
It is applicable to maintain storage condition in RM & PM at Stores and Production Departments
3. RESPONSIBILITY
• Production Pharmacist
• Quality Assurance officer
4. SAFETY INSTRUCTIONS
• N/A
5. PROCEDURE
5.1 PRODUCTION AREAS
5.1.1 Production officer shall ensure that all the air conditioners of the respective areas switch “ON”.
5.1.2 Production officer shall note down the temp & humidity twice in a day in all areas. The specific time for noting temperature shall be 8.00 to 9.30 am & 01.00 to 03.00 Hrs.
5.1.3 If any abnormalities are observed during the recording, Production officer shall inform to Production Head.
5.1.4 Production Head, in turn, shall inform the observed abnormalities to QA head, Plant Head and Engineering Head for further rectification and action.
5.1.5 All notify reading by production officer will be verified by QA officer
5.2 STORE AREAS
5.2.1 Store person shall ensure that all the air conditioners of the respective store areas switch “ON”.
5.2.2 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 & 1.00 to 3.00 Hrs.
5.2.3 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 & 1.00 to 3.00 Hrs.
5.2.4 If any abnormalities are observed during the recording, store person shall inform to store Head.
5.2.5 Store Head, in turn, shall inform the observed abnormalities to QA head, Plant Head and Engineering Head for further rectification and action.
5.3 Note: Temperature and relative humidity is important from the point of view of-
5.3.1 To avoid degradation of products.
5.3.2 To ensure comfortable and hygienic working of workmen as per GMP norms.
5.3.3 To avoid damage to hard gelatin capsule shells.
6. RELATED DOCUMENTS
Format for Recording of temperature and Humidity – Annex-I
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Quality Control Department | 01 | , |
| Production Department | 01 | , |
| Warehouses | 01 | , |
8. ABBREVIATIONS
QA Quality Assurance
GMP General Manufacturing Practice
N/A Not Applicable
9. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 10/08/2022 | 00 N/A | First Version |