Handling And Testing Of Various Samples
1.0 OBJECTIVE:
To
clearly lay down procedure for handling and testing of various samples.
2.0 SCOPE:
This
procedure is applicable to various samples such as MISCELLANEOUS, VALIDATION
& STABILITY SAMPLES for analysis at Q.C.
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 various sample along with in-process sample test request slip or
various correspondence from
various sites, Q.C will give Q.C REPORT No. as per below. X0Y/000Z.
5.1.1
For
sample received from VALIDATION allot numbering where X= VA.
5.1.2
For
sample received from MISC. (Other than insulin) allot numbering where X= MIS.
5.1.3
For
sample received from STABILITY numbering where X= STB.
5.1.4
0Y=
Year of sample receipt i.e. = 01 for year 2001, 05 for year 2005 etc.
5.1.5
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 samples
along with testing slip.
5.4
After completion
of entry, put the sample in to “UNDER TEST SAMPLE” tray.
5.5
Q.C in-charge/ Executive
shall distribute the sample along with intimation slip or IC to the chemical
section and instrument section for respective analysis.
5.6
Chemist shall
analyse the sample as per respective method of analysis & specification and
record the results in testing sheet.
5.7
On completion of
testing, submit the report to Q.C in-charge/ Executive for checking.
5.8
Q.C in-charge/
Executive shall check the results of chemical and instrumental testing.
5.9
Sign the report.
5.10
Q.C in-charge/
Executive enter the results into respective in-process entry register.
5.11
After completion
of entry, Q.C in-charge/ Executive shall convey the result to respective dept.
5.12
In absence of
responsible person, technical assistant shall convey the results to production
dept. along with in-process sample test request slip.
5.13
After completion
of testing, destroy the sample as per SOP.
5.14
File the report in
to respective file.
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 |
|
& |
And |
|
No. |
Number |
|
No. |
Number |
|
Sr.No. |
Serial number |
|
A.R.
No. |
Analytical report
number |
|
Mfg. |
Manufacturing |
|
Exp. |
Expiry |
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