Retention Of Old Record Of Quality Control
1.0 OBJECTIVE:
To
lay down the documented procedure for retention of the old record of quality
control department.
2.0 SCOPE:
This
SOP is applicable for retention of old record of 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:
All
5.1 the
documents generated by quality control departments should follow the following
schedule & should be destroyed in presence of the responsible person after
their retention period is over.
5.2 All
the standard operating procedures are to be retained for 2 years after they
have been revised. After completion of 2 years, review the standard operating
procedures.
5.3 All
the analytical reports (e.g. raw materials, packing materials, in-process/
intermediates and finished products) are to be retained for 5 years.
5.4 All
quality control reporting formats/ logbooks are to be retained for 5 years.
5.5 All
the specifications are to be retained for 2 years after they have been revised.
|
Revision No. |
Effective Date |
Reason |
|
00 |
01/07/2020 |
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 |