Collection And Storage Of Retained Samples Of Raw Material
1.0 OBJECTIVE:
To
collect and store pre-decided sample quantity from each raw material received
for the formulation plant except Acids, alkalis & solvents.
2.0 SCOPE:
This
procedure is applicable to all raw material received for the formulation plant
except Acids, alkalis & solvents.
3.0 RESPONSIBILITY:
3.1
Doing: Tech. Asst.
/Executive.
3.2
Checking:
Executive/ Manager.
4.0 ACCOUNTABILITY:
4.1
Head of the Department.
5.0 PROCEDURE:
5.1
Collect required
quantity of retain sample from raw material received.
5.2
Take the sample in
plain & black poly bags (in case if light sensitive material).
5.3
Keep this bag in
the air tight plastic container.
5.4
Place the label on
the plastic container having details as shown in annexure 1.
5.5
Enter the data in
the ‘Retain sample register’ as per annexure 2 details.
5.6
Keep the plastic
container in the box No. as specified in the register.
5.7
Store the retain
sample container for 10 years as per list of storage condition available in Q.C
dept.
5.8
Destroy the retain
samples after 10 years.
5.9
Prepare the list
of RM to be destroyed and get the approval for the same.
5.10
For destruction of
retain samples soak the material in water or collect the liquid material &
retain by flushing with excess if water.
5.11
Transfer the empty
bottles, containers to scrap area as per Ref. SOP.
5.12
Preserve the
destruction record for 5 years after the date on which they are destroyed.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
Annexure 1: Label
of retain sample.
Annexure 2: Retain
sample register requirements.
Annexure:
1
Label
of retain sample
|
RETAIN SAMPLE Name
of Material: ____________________________ Batch
No.: ___________________ Date:
______________________ Quantity:____________________ A.R. No.:
__________________ ___________ Pharmaceuticals
|
Annexure:
2
Retain
sample register requirements
|
RETAIN SAMPLES DATA
SHEET
___________ Pharmaceuticals
|
9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
S |
Standard operating
procedure |
|
& |
And |
|
% |
percentage |
|
Sr.# |
Serial number |
|
Dept. |
Department |
|
RM |
Raw material |
|
Tech. |
Technical |
|
Asst. |
Assistant |
|
A.R. No. |
Analytical report
number |
|
Qty. |
Quantity |
|
Sign |
Signature |