Function Of Quality Control Department
1.0 OBJECTIVE:
To
lay down the documented procedure for functions of quality control department.
2.0 SCOPE:
This
SOP is applicable for role of quality control department in Pharmaceutical
industry.
3.0 RESPONSIBILITY:
3.1
Q.C. Officer/Executive-Quality
Control.
4.0 ACCOUNTABILITY:
4.1
Manager-Quality
Control.
4.2
Head of the Q.C Department.
5.0 PROCEDURE:
5.1 List
of activities of quality control department.
5.1.1
Testing and release
or rejection of all incoming raw materials, packing materials, in-process/
intermediates and finished products as per specified specifications.
5.1.2
Maintaining
testing records as per standard procedures for raw materials, packing
materials, in-process/ intermediates and finished products.
5.1.3
Calibration of
laboratory instrument/ equipment.
5.1.4
Performing
stability study.
5.1.5
Control sample
storage.
5.1.6
Analytical method
validation.
5.1.7
Preparation of
standard volumetric solutions and maintain standardization record.
5.1.8
Maintain labeling
procedure at all the stages and records.
5.1.9
Maintain working/
reference standard record of products.
5.1.10 Analysis
of complaint samples as and when required.
5.1.11 To
conduct technical audit/ self-inspection.
5.1.12 Follow
safety norms at all the stage during handling of chemicals and using
instruments.
5.1.13 Follow
good laboratory practices.
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 |