Hold Time For Materials SOP
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1.0
PURPOSE:
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1.1. The purpose of this document is to define the
maximum hold time of materials in quarantine and in-process product’s bulk.
2.1. This
procedure is applicable to all starting materials and products being processed
at ______Plant
3.1. Q.A Manager
3.2. Q.A Officer
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4.0 PROCEDURE:
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4.1 HOLD TIME OF
STARTING MATERIALS IN QUARANTINE
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S.
#
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Description
of Materials
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Maximum
Hold Time in Quarantine
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Storage
Conditions
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1
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API
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5 working days
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As per relevant specifications
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2
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Excipients
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7 working days
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As per relevant specifications
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3
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Packing Materials
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7 working days
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As per relevant specifications
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4
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Dispensed Raw Material
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2 working days
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As per relevant specifications
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4.2. HOLD TIME OF BULK PRODUCTS IN PRODUCTION AREA
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S. #
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Description of Products
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Maximum Hold Time in Quarantine
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Storage Conditions
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1
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Grains
of OSD Products
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3 days
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As
per relevant specifications
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2
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Core
Tablets
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7 days
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As
per relevant specifications
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3
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Coated
Tablets
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7 days
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As
per relevant specifications
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4
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Blisters
of Tablets & Capsules
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30 days
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As
per relevant specifications
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5
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Moisture
Sensitive Grains/ Tablets
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24 hrs.
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As
per relevant specifications
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6
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Filled
Capsules
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7 days
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As
per relevant specifications
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7
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Bulk
of Liquid Syrup
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2 days
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As
per relevant specifications
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8
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Filled
& Sealed Bottles of Liquid Syrup
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30 days
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As
per relevant specifications
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4.3 This hold time is
tentative and valid till evaluation / study / of hold time of individual
products.
4.4 QA after evaluation
/ determination of hold time of individual product will issue the hold time of
that product accordingly.
4.5 In case of deviation
of valid hold time QA will issue deviation report / NCR to investigate the
reason of deviation.
In case of deviation
of valid hold time, product will be retested before next process.
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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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NCR Record (F-07-009)
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FORMAL KPIs (Key Performance Indicators)
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Proper retention of materials at different
stages
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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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SOP is not being followed for holding materials
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Material/product gets out of specifications
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Always Follow the SOP
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QA Officer/ QA Attendant
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