Tuesday, November 30, 2010

Instruction For Inspection Of Control Sample

1.0         Purpose   :    To provide an instruction for inspection of control sample.

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

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

4.0         Responsibility  :
·       Primary: QC Chemist / QC Officer
·       Secondary : Overall: QC – Incharge

5.0       Procedure   :
·       Take entry of all the products batch wise manufactured; in the Control sample observation logbook after QC release.
·       Keep the samples in Control sample as per standard procedure of control sample.
·       The QC Chemist should check control samples randomly by visually at a frequency of every 12 months form the kept on date entry.
·       QC chemist shall carry out the visual test for description of product as mentioned in specification of the relevant product.
·       If any abnormalities observed in any product and batch, inform to the QC In-charge immediately, and record it accordingly.
·       If found satisfactory than mentioned ‘found satisfactory” remark in the Control Sample Inspection logbook.

6.0      Reference Document:
v      Control Sample logbook

Product: ___________________________               Product Code: ____________________


Batch No.
Date of mfg.
Date of exp.
Kept on
12 months
Date of observation
Checked by


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