Preservation Of Control Samples Of Active Ingredients
1.0 OBJECTIVE:
To
lay down the procedure for preservation of Control samples of active
ingredients.
2.0 SCOPE:
This
SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:
3.1
Quality Control
Supervisor.
4.0 ACCOUNTABILITY:
4.1
Sr. Manager
Quality Assurance.
4.2
Head of the Q.C Department.
5.0 PROCEDURE:
5.1
Control samples of
all active ingredients used in drug products shall be retained in sufficient quantity.
5.2
A label should be
pasted bearing all the relevant details like Name of the sample, batch number,
supplier, mfg. date, expiry date, etc.
5.3
Reserved samples
of all active ingredients shall be stored in Chemical Stores of Laboratory.
5.4
Control samples of
active ingredient shall be sufficient enough for at least 2 complete analysis.
5.5
Control samples of
active ingredients shall be retained one year after expiry of the last batch/
lot of the product in which it is used.
5.6
Control samples of
active ingredients shall be destroyed as per SOP.
5.7
Lot No. /Batch No.
of drug products in which that particular active ingredient is used shall be
made available from BMR.
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 |