Thursday, December 2, 2010
In–Process Quality Control Records
1.0 Purpose : To provide a documented procedure for In–process Quality control Records.
2.0 Objective : To provide a guide line for In–process Quality control Records.
3.0 Scope : Procedure for In- process Quality control & Records.
4.0 Responsibility :
· Primary: Production chemist.
· Secondary : Production Officer.
5.0 Procedure :
Ø Start Batch as per BMR of the product to control the progress of reaction and follow In- process Quality control system norms and the procedure to be followed as under.
Ø As per progress of the batch and after completion of mentioned time of the reaction, remove the sample and send to Q.C for analysis in cleaned bottle.
Ø Fill the sample details of product name/ stage/ B. No./ reaction time and sampling equipment in specially designed form for IPQC test i.e. INPROCESS TEST information sheet Collect the result of IPQC sample with Document duly signed by Q.C. analysis.
Ø Send the filled IPQC form to Q.C. department for immediate sample analysis.
Attach IPQC report with BMR and fill analysis report in BMR