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.

6.0 REVISION LOG: