| In Process Analytical Request For Bulk/ Semi Finished/ Finished Goods Samples |
1.0 OBJECTIVE: 1.1 To lay down a procedure for In- Process Analytical Request for Bulk/ Semi Finished/ Finished Goods Samples to IPQA for analysis. 2.0 SCOPE: 2.1 This procedure is applicable for the In- Process Analytical Request for Bulk/ Semi Finished/ Finished Goods Samples. 3.0 RESPONSIBILITY: 3.1 Officer Production : To produce sampling request and inform to IPQA person. 3.2 IPQA : To receive the sampling request as per this SOP. 3.3 Manager Production : To ensure the compliance of SOP. 4.0 PROCEDURE: 4.1 After completion of the stage at which the process has reached. Production person shall complete the BMR & BPR in all respect up to the stage. To Read this SOP Click here SOP for Operation & Cleaning Of Quarantine Storage Tanks. 4.2 Production person shall produce In-Process Analytical Request with following details: 4.2.1 Stage (Bulk/ Semi Finished/ Finished Goods) 4.2.2 Product Name 4.2.3 Batch No. 4.2.4 Batch Size 4.2.5 Mfg. Date 4.2.6 Exp. Date 4.2.7 Requisition given be (Sign/Date) 4.2.8 Production Request No. 4.2.9 AR No. 4.2.10 Sample quantity 4.2.11 Sampled by 4.2.12 Received in QC 4.2.13 Date 4.2.14 Test For 4.2.15 Analysed by 4.2.16 Released by NOTE: A duplicate copy of In-Process Analytical Request shall be given at every stage for QC record. 4.3 After completion of In-Process Analytical Request, production person shall record the details in In-Process sample register. 4.4 Production person shall inform IPQA person through In-Process Analytical Request. 5.0 ABBREVIATIONS 5.1 SOP : Standard Operating Procedure 5.2 BMR : Batch Manufacturing Record 5.3 BPR : Batch Packing Record 5.4 IPQA : In-Process Quality Assurance 5.5 QC : Quality Control |
