Raw Material Release SOPs
1.0 OBJECTIVE:
To
clearly lay down procedure for release of raw materials.
2.0 SCOPE:
This
procedure is applicable for all raw materials.
3.0 RESPONSIBILITY:
3.1
Doing: Technical Assistant/ Executive.
3.2
Checking: Executive / Manager.
4.0 ACCOUNTABILITY:
4.1
Head of the Department.
5.0 PROCEDURE:
5.1
On receipt of the raw material sample from
store to Q.C put into “Under Test Sample” tray kept at designated place.
5.2
Enter the details in the raw material
register.
5.3
Distribute the sample for Chemical,
Instrument and other tests as per specification.
5.4
Issue the photocopy of protocol and COA
format for analysis from controlled computer system and put the date and
signature on it.
5.5
Carry out the identification test
separately for active raw material for each container.
5.6
For active raw materials perform rest of
the test as per the specification from the composite sample prepared from all
containers.
5.7
For active raw materials, perform the
assay test from the composite sample prepared from each 10 container &
report the average value in the certificate of analysis.
5.8
For inactive raw materials perform the
complete testing as per specification from the composite sample prepared from
the sampled containers.
5.9
Write the identification no. of instrument
which is used for analysis on protocol.
5.10
Enter all results in protocol and
accordingly in COA and complete the testing.
5.11
On completion of testing enter the detail
in the raw material receiving report under the
heading
of:
5.11.1
Approved/ rejected quantity.
5.11.2
In case of active raw material as such
assay.
5.11.3
Date of release/ rejected.
5.11.4
Approved/ rejected status.
5.12
Submit material receiving report and
testing report to Q.C In-charge for checking and
signing
it.
5.13
Attach Q.C copy of MRR with sampling
report and file it.
5.14
Check the test report, enter the detail in
the register and file it.
5.15
Send remaining two copies of MRR to R.M
store.
5.16
Enter the details in computer for assay
(for active) and change the status to Approved/
Rejected
status of respective A.R. No. by the authorized person to whom passwords
are
allotted.
5.17
Take out the print out of assay status
list daily. Verify by concern Executive/ Asst.
Manager
& submit one copy to production in-charge & other copy to R.M store.
5.18
Print out the required no. of status label
from the computer.
5.19
Enter following details for green
“APPROVED” label.
A.R. No.:
Approved by :
Date:
Retest Due Date:
5.20
In case of Rejection, write following
details on red “REJECTED” label.
A.R. No. :
Rejected by
:
Date:
Reason :
5.21
Paste APPROVED/ REJECTED label over the
word “UNDER TEST” on yellow label.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
01/07/2021 |
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 |