Saturday, November 27, 2010

Testing and Release of In-Process samples.

1.0         Purpose   :     To provide an instruction for testing and release of in-process samples.

2.0         Objective  :  To provide a documented procedure for testing and release of in-process samples.

3.0              Scope   :  This procedure is applicable for testing and release of in-process samples in QC                   department of-----Pharmaceuticals Ltd.
4.0         Responsibility   :
·       Primary     :    QC Chemist / QC Officer
·       Secondary   :   Overall: QC – Incharge

5.0       Procedure  :
·        After the receipt of test request from production to QC Lab, the QC Chemist takes its entry in the IPQC register or Test request register.
·        Based on the priority, chemist analyzes the In-process samples by referring the in-process specifications.
·        After completion of work fill the testing worksheet & test request along side and attaches the graphs etc. along with worksheet & test request.
·        The completed Worksheet & test request is given to Q. In-charge who checks it and declares the material is to be approved / Rejected / to be reworked /Re-analyzed.
·        Subsequently, the required entries are to be made in the In-process register.
·        If product / sample comply the specification, it is released for next step. And if it does not complies the specification, inform to production for reprocessing.

6.0      Reference Document  :  
v            In-process log book
Log Book For In process Check.
Sr. No.
Receipt Date
Product & Stage
B. No
Sample Qty
A.R No.

Date Of Analysis
Release Date
Checked By


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