Storage Condition for Different Areas SOP
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1.0
PURPOSE:
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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
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4.0 PROCEDURE:
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1.1.1.
Storage
conditions for different areas are as under:
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S. #
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Area
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Storage Conditions
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Remarks
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Temp.
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R/H
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1
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Raw Material Store
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NMT 30 0C
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NMT 60 %
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2
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Dispensing of Raw Material
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NMT 25 0C
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NMT50 %
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3
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Packing Material Store
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NMT 30 0C
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NMT 60 %
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4
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Finished Goods Store
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NMT 30 0C
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NMT 60 %
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5
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In-Process Quarantines of
Production
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NMT 30 0C
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NMT 60 %
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6
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Manufacturing Areas of OSD
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NMT 25 0C
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NMT50 %
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7
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Manufacturing Areas of Sachet.
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NMT 25 0C
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NMT40 %
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8
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Manufacturing Areas of Liquid
Syrup/ Oral Solutions.
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NMT 25 0C
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NMT60 %
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9
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Retain Samples Room
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NMT 30 0C
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NMT 60 %
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5.0
REVIEW
FREQUENCY:
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SOP will be reviewed at least annually.
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EVIDENCES OF RECORDS & REFERENCES
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Temp And Humidity Log (F-BM-001)
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FORMAL KPIs
(Key Performance Indicators)
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Maintaining the record and availability of the
record as and when required.
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GENERAL RISKS
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CONTROL MEASURES
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CUSTODIAN
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Risks
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Impact
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Temperature and Relative Humidity Not Properly
Maintained
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Sticking of Powder or Tablets, Capsules
may occur
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Affix the Hygrometers on the walls of all areas.
Maintain the Log of Temp. & Humidity on daily basis two
times.
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QA Officer/
QA Attendant
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