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)
FORMAL KPIs (Key Performance Indicators)
Proper retention of materials at different stages
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



No comments:

Post a Comment