Retesting Schedule Of Raw Material
1.0 OBJECTIVE:
To
ensure compliance of quality of approved raw material at regular interval
during storage.
2.0 SCOPE:
This
procedure is applicable for retesting of approved active and inactive raw
material, which are stored in the raw material store.
3.0 RESPONSIBILITY:
3.1
Doing: Technical Assistant.
3.2
Checking: Executive/Manager.
4.0 ACCOUNTABILITY:
4.1
Head of the Department.
5.0 PROCEDURE:
5.1
On receipt of raw material, enter
retesting date on MRR and in the computer system on the basis of list prepared
for active & inactive RM respectively on all approved labels.
5.2
Retest due date shall not be more than
expiry date of raw material.
5.3
Give two years retest due date for all
materials from the date of sampling.
5.4
For the material having lower expiry date
than 2 years retest period, assign the retest date for 1 year or half the
period in that case.
5.5
Receive the information from the stores
one month in advance for the material due for retesting.
5.6
Sample the material for retesting as per
schedule as per the list received from RM store and verify against previous
records.
5.7
Put the sampled stamp on the drums
selected for sampling.
5.8
Affix “UNDER RETEST” label on each
container and cross out “Approved” label with marker on all the containers.
5.9
Change the status of material in the
computer from “Approved” to “Under test” if materials are not sampled &
tested before the due date of retest.
5.10 The
color of “UNDER RETEST” label is blue, and enters the following details in the
label.
5.10.1
Name of Material :
5.10.2
A.R No. :
5.10.3
Sampled by :
5.10.4
Date :
5.11
Mark “SAMPLED” stamp on containers from
which the samples are collected.
5.12
Carry out the following test for each raw
material as applicable.
5.12.1
Description.
5.12.2
L.O.D/Water content.
5.12.3
Chromatographic purity/Related substances.
5.12.4
Assay.
5.12.5
Microbial limit test.
5.12.6
pH/ acidity/ alkalinity test.
5.12.7
Bacterial endotoxin test.
5.13
On approval, affix “APPROVED” label with new retesting date on all the containers.
5.14
Give the new retesting date as per the
list annexure I & II considering the previous
retesting
due date as initial date.
5.15
If material is rejected affix “REJECTED” label on each container.
5.16
Change the status of the material in
computer from “Under test” to “Approved”/
“Rejected”
if status is change to under test as per point 5.9.
5.17
Prepare a test report after analysis if it
conforms to specification assign a new retest
due
date on approved label and get it signed by Q.C in-charge.
5.18
If the material fails, initiate the
disposition of the material after due scrutiny by
concerned
authorities.
5.19
Keep the record of retesting in separate
file.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
01/07/2020 |
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
8.1
Not Applicable.
9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
S
|
Standard
operating procedure |
|
& |
And
|
|
% |
Percentage |