Tuesday, November 30, 2010

Role Of Quality Control Department In Rejection

1.0         Purpose    :  To provide an instruction for role of quality control department in rejection.

2.0         Objective  :  To provide a documented procedure for role of quality control department in rejection.

3.0          Scope     :   This procedure is applicable for role of quality control department in rejection ----- Pharmaceuticals Ltd,
4.0         Responsibility  :
·        Primary      :  QC Chemist / QC-Officer
·         Secondary :  Overall: QC – In charge

5.0       Procedure   :
·        QC Chemist when comes across any non-conformance, he himself cross checks the finding.
·        The findings are again verified by QC In charge.
·        Upon confirmation he informs to QA and fills OOS and follows OOS procedure.
·        After the study of OOS, QA person put remark on OOS (Reject /Approve.)
·        The QC Personnel prepares the rejection report, which is signed by Q.C. In-charge and is stamped as “Rejected” in “RED INK”.
·        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      Reference Document  :
v     Rejection Record.
Sr No.
Name of Material/ Product.
AR. No.
B. No
Reason for Rejection
Rejected  by
Approved by.


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