Storage Condition for Different Areas SOP


1.0   PURPOSE:

1.1.            The purpose is to define storage conditions in different areas for storage of different areas.


2.1. This procedure is applicable to all materials and products being processed at ____   
         Pharmaceuticals.


3.1.      Quality Assurance Manager
3.2.      Quality Control Manager
3.3.      QA Officer
3.4.      Area Incharge

4.0    PROCEDURE:

1.1.1.      Storage conditions for different areas are as under:
S. #
Area
Storage Conditions
Remarks
Temp.

R/H

1
Raw Material Store
NMT 30 0C
NMT 60 %

2
Dispensing of Raw Material
NMT 25 0C
NMT50 %

3
Packing Material Store
NMT 30 0C
NMT 60 %

4
Finished Goods Store
NMT 30 0C
NMT 60 %

5
In-Process Quarantines of Production
NMT 30 0C
NMT 60 %

6
Manufacturing Areas of OSD
NMT 25 0C
 NMT50 %

7
Manufacturing Areas of Sachet.
NMT 25 0C
NMT40 %

8
Manufacturing Areas of Liquid Syrup/ Oral Solutions.
NMT 25 0C
 NMT60 %

9
Retain Samples Room
NMT 30 0C
NMT 60 %




5.0     REVIEW FREQUENCY:

SOP will be reviewed at least annually.


EVIDENCES OF RECORDS & REFERENCES
Temp And Humidity Log (F-BM-001)
FORMAL KPIs
(Key Performance Indicators)
Maintaining the record and availability of the record as and when required.
GENERAL RISKS
CONTROL   MEASURES

CUSTODIAN

Risks
Impact



Temperature and Relative Humidity Not Properly Maintained
Sticking of Powder or Tablets, Capsules may  occur
Affix the Hygrometers on the walls of all areas.
Maintain the Log of Temp. & Humidity on daily basis two times.
QA Officer/
QA Attendant



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