Record Maintained By Quality Control
1.0 OBJECTIVE:
To
lay down the documented procedure for record maintained by quality control
department.
2.0 SCOPE:
This
SOP is applicable forrecord maintained by quality control department in
Pharmaceutical industry.
3.0 RESPONSIBILITY:
3.1
Q.C. Chemist/ Q.C.
Officer.
4.0 ACCOUNTABILITY:
4.1
Manager-Quality
Control.
4.2
Head of the Q.C Department.
5.0 PROCEDURE:
5.1 Following are
control documents:
5.1.1
Standard operating
procedures of Quality control department.
5.1.2
Specifications of
raw material.
5.1.3
Specifications of
packing material.
5.1.4
Specifications In-process/
intermediate.
5.1.5
Specifications
finished product.
5.1.6
Standard test
procedures of raw material.
5.1.7
Standard test
procedures of packing material.
5.1.8
Standard test
procedures of In-process/ intermediate.
5.1.9
Standard test
procedures of finished product.
5.1.10 List
of instruments.
5.2 Following are
records:
5.2.1
Raw materials
testing records.
5.2.2
Packing materials
testing records.
5.2.3
In-process/
intermediates testing records.
5.2.4
Finished products
testing records.
5.2.5
Instrument
calibration records.
5.2.6
Stability study
records.
5.2.7
Glassware
calibration records.
5.2.8
Raw material
inward logbook.
5.2.9
Raw material work
sheet issuance logbook.
5.2.10 Intermediate
inward logbook.
5.2.11 Intermediate
work sheet issuance logbook.
5.2.12 Finished
product inward logbook.
5.2.13 Finished productwork sheet issuance logbook.
5.2.14 In-process
samples inward logbook.
5.2.15 Instrument
uses logbooks.
5.2.16 HPLC
column logbook.
5.2.17 Stability
chamber logbook.
5.2.18 Laboratory
cleaning logbook.
5.2.19 Volumetric
solution logbook.
5.2.20 Standard
reagent solution logbook.
5.2.21 Indicator
logbook.
5.2.22 Retention
sample logbook.
5.2.23 Logbook
issuance logbook.
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 |
|
HPLC |
Higher performance
liquid chromatography |