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. | Sample Receipt Date | Product & Stage | B. No | Sample Qty | Test | A.R No. |
| | | | | | |
Date Of Analysis | Result | Release Date | Done By | Checked By |
| | | | |
Format:-F/QC/009 |
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