Control Sample Handling

1.0         Purpose   :    To provide an instruction for control sample handling.

2.0         Objective  :   To provide a documented procedure for control sample handling.

3.0              Scope   :   This procedure is applicable for control sample handling in QC laboratory of ------  Pharmaceuticals Ltd,Ankleshwar.

4.0         Responsibility  :

·      Primary       : QC Chemist / QC Officer

·      Secondary   :  Overall: QC – Incharge 

5.0       Procedure    :

·      The samples drawn by the QC chemist shall be brought to Quality Control department.

·      Necessary entries shall be made in the Control Sample log book

·      After completion of testing and approved, prepare control sample for each products.

·      Quantity of control sample should be required two times testing (about 50 g).

·      Place the sample in white container and label to the box or to bottle to identify the     control samples under lock and key.

6.0      Reference Document   :

v           Control Sample logbook.

LOG BOOK FOR CONTROL SAMPLES

Product: __________             Product Code: __________               Year: _________

Sr No.	Date	Batch No.	Date of Mfg.	Date of Exp.	Qty	Analyzed by		Control sample		Due date for destruction	Remark
						Sign	Date	PartyName	Kept by
Format:-F/QC/011