Procedure For Retest Period of Raw Material
1.0 Objective
To have a systematic procedure for Retest Period of raw material.
2.0 Scope
Raw Material received by store at abc company
3.0 Responsibility
3.1 Executive – Quality Control.
3.2 In charge/Head-Quality Control.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality Control
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
G : General
5.0 Procedure
5.1 The raw materials which are received by the stores and intimated to Quality Control department
is first tested for its Quality by Quality Control Department.
5.2 Approved Raw Material is assigned defined retest date as per the schedule given below.
MATERIALS RESULTS VALID UPTO
5.2.1 Active Ingredients 12 Months
5.2.2 Degradable Material 6 Months
5.2.3 All Excipients 12 Months
5.3 Once the validity period for tested Material is over the stores intimate to
Quality Control Department for reanalysis.
5.4 This material is re-tested for complete for complete analysis. If found passing the retest
date I allotted to the said Raw material is as per Schedule.
6.0 Forms and Records
6.1 None.
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Assurance, Quality Control
8.0 History
Revision Number | Details For Change |
Reason for Revision |
00 | New SOP | NA |
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