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:

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

 

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