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

 

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