Handling And Testing Of In-Process Sample\
1.0 OBJECTIVE:
To
clearly lay down procedure for handling and testing of in-process sample.
2.0 SCOPE:
This
procedure is applicable to the in-process samples of formulation such as
granules core tablet etc.
3.0 RESPONSIBILITY:
3.1
Doing: Tech. Asst.
/Executive.
3.2
Checking:
Executive/ Asst. Manager/ Manager.
4.0 ACCOUNTABILITY:
4.1
Head of the Q.C Department.
5.0 PROCEDURE:
5.1
On
receipt of in-process sample along with in-process test request slip from manufacturing
dept., Q.C will allot Q.C REPORT No. as per below. X0Y/000Z.
5.1.1
For
in-process sample from Tablet allot numbering where X= G.
5.1.2
For
in-process sample from capsule allot numbering where X= M.
5.1.3
0Y=
Year of sample receipt i.e. = 03 for year 2003, 04 for year 2004 etc.
5.1.4
000Z=
serial number staring from 0001….
5.2
Make
the entry respectively in in-process register with following details.
5.2.1
Sr.
No.
5.2.2
Batch
No.
5.2.3
Q.C.
A.R. No.
5.2.4
Mfg.
Date.
5.2.5
Exp.
Date.
5.2.6
Batch
Size.
5.2.7
Date
of Receipt
5.3
Distribute data
sheet as per Annexure.
5.4
After completion
of entry, put the sample in to “UNDER TEST SAMPLE” tray.
5.5
Q.C section
in-charge/ Executive shall distribute the sample along with intimation slip and
data sheet to the chemical section and instrument section for respective
analysis.
5.6
Chemist shall
analyse the sample as per respective method of analysis and record the results
in data sheet & similarly enter results in SAP system.
5.7
On completion of
testing, give report to Q.C section in-charge/ Executive for checking.
5.8
Q.C section in-charge/
Executive shall check the results of chemical and instrument testing.
5.9
Sign the report.
5.10 Q.C
section in-charge/ Executive enter the results into respective in-process entry
register.
5.11 After
completion of entry, Q.C section in-charge/ Executive will fill the results in
the In-process sample test request slip in duplicate and will put their sign in
it.
5.12 Q.C
section in-charge/ Executive will send Blue slip to production and attach the
yellow slip with testing report.
5.13 In
absence of responsible person, technical assistant shall convey the results to
production dept. along with in-process sample test request slip.
5.14 After
completion of testing, destroy the sample as per SOP.
5.15 File
the report in to respective file.
5.16 Note: Allotting
Q.C Report No. after completion or before completion of analysis.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
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 |
|
Tech. |
Technical |
|
Asst. |
Assistant |
|
Sr.No. |
Serial number |
|
A.R.
No. |
Analytical report
number |
|
Mfg. |
Manufacturing |
|
Exp. |
Expiry |
|
SAP |
Systems applications
& products |