Storage Condition for Different Areas SOP

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.

2.0    SCOPE:

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

         Pharmaceuticals.

3.0   RESPONSIBILITY:

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.

6.0      RISK ANALYSIS:

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