Role Of Quality Control Department In Rejection

Role Of Quality Control Department In Rejection

 

1.0  OBJECTIVE:

To lay down the documented procedure for role of quality control department in rejection.

2.0  SCOPE:

This SOP is applicable for role of quality control department in rejection 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  Q.C chemist when come across any non-conformance, he himself cross checks the finding.

5.2  The findings are again verified by Q.C in-charge.

5.3  Upon confirmation he informs to Q.A and fills OOS and follows OOS procedure.

5.4  After the study of OOS, Q.A person put remark on OOS (Reject/ Approve).

5.5  The Q.C Personnel prepares the rejection report, which is signed by Q.C In-charge and is stamped as “Rejected” in “RED INK”.

5.6  The rejected labels are affixed on the containers of rejected material as rejected “RED INK” and these containers are segregated from the remaining stock under lock and key with restricted access.

6.0  REVISION LOG:

Revision No.	Effective Date	Reason
00	July-2020	New SOP

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

Annexure 1: Rejection record.

Annexure: 1

Rejection Record

Rejection record Sr.# Date Name of material/ Product AR. No. B. No. Qty. Reason for rejection Rejected by Approved by                                                                                                                                                                                       Format: F/QC/000

 

9.0  ABBREVIATIONS:

Abbreviation	Expanded Form
S	Standard operating procedure
&	And
%	Percentage