Hold Time For Materials SOP
1.0
PURPOSE:
|
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
4.0 PROCEDURE:
|
4.1 HOLD TIME OF
STARTING MATERIALS IN QUARANTINE
S.
#
|
Description
of Materials
|
Maximum
Hold Time in Quarantine
|
Storage
Conditions
|
1
|
API
|
5 working days
|
As per relevant specifications
|
2
|
Excipients
|
7 working days
|
As per relevant specifications
|
3
|
Packing Materials
|
7 working days
|
As per relevant specifications
|
4
|
Dispensed Raw Material
|
2 working days
|
As per relevant specifications
|
4.2. HOLD TIME OF BULK PRODUCTS IN PRODUCTION AREA
S. #
|
Description of Products
|
Maximum Hold Time in Quarantine
|
Storage Conditions
|
1
|
Grains
of OSD Products
|
3 days
|
As
per relevant specifications
|
2
|
Core
Tablets
|
7 days
|
As
per relevant specifications
|
3
|
Coated
Tablets
|
7 days
|
As
per relevant specifications
|
4
|
Blisters
of Tablets & Capsules
|
30 days
|
As
per relevant specifications
|
5
|
Moisture
Sensitive Grains/ Tablets
|
24 hrs.
|
As
per relevant specifications
|
6
|
Filled
Capsules
|
7 days
|
As
per relevant specifications
|
7
|
Bulk
of Liquid Syrup
|
2 days
|
As
per relevant specifications
|
8
|
Filled
& Sealed Bottles of Liquid Syrup
|
30 days
|
As
per relevant specifications
|
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.
5.0
REVIEW
FREQUENCY:
|
SOP will be reviewed at least annually.
EVIDENCES OF RECORDS & REFERENCES
|
NCR Record (F-07-009)
|
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FORMAL KPIs (Key Performance Indicators)
|
Proper retention of materials at different
stages
|
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GENERAL RISKS
|
CONTROL MEASURES
|
CUSTODIAN
|
||
Risks
|
Impact
|
|||
SOP is not being followed for holding materials
|
Material/product gets out of specifications
|
Always Follow the SOP
|
QA Officer/ QA Attendant
|
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