I.
PURPOSE :
To provide a written procedure for Re-testing of Raw Materials and Intermediates
II.
SCOPE:
This SOP is applicable to all the Raw Materials and Intermediates.
III.
RESPONSIBILITY:
It is the Responsibility of Quality Control Dept., stores/ware house, production and
Quality Assurance to follow the procedure given in this SOP.
IV.
DOCUMENT REFERENCE :
SOP : Nil.
Form : Nil
V
PROCEDURE :
New product intermediates/Raw material :
1.2
For any new product intermediates/Raw materials, data pertaining to shelf life/re-test
date has to be provided during the technology transfer.
1.3
In case of raw materials, R&D shall obtain the retest date from the vendor
1.3 In case data is not provided during technology transfer/vendor then data shall be
generated. Select any one approved batch and collect sufficient quantity (required for
carrying out all the tests) of sample into four packets and store it in a packing similar
to the regular packing. Store the samples at the regular material (plant/warehouse)
storage condition. Analyse at duration of 1st month, 3rd month, 6th month and 12th
month for description, water/LOD, purity, assay and other relevant tests as per the
requirement of particular product.
2.1
2.0
Old/Existing product intermediates/Raw material :
Prepare the report based on retrospective data of re-test or any reference material
(working standard) used at different occasions for the analysis of test sample i.e
identification, Purity by GC purity by HPLC.
3.0
Evaluation : Based on retrospective data or shelf life study data, assign the re-test date
as follows.
3.1
If there is no change in general test like description, water/LOD, purity, assay and
other relevant tests as per the requirement of particular product, Re-test can be
assigned as follows.
-
If no data is available re-test can be assigned as 180 days
-
re-test can be assigned based on stability data.