Purpose:
This SOP describes the procedure for Handling and Storage of dispensed Raw Materials.
Procedure:
Handling of Dispensed Raw Material
- After completion the dispensing of Raw Materials wrap with one more polybag and transferred to “Dispensed Quarantine” through SS trolley.
- Unload the material on a clean pallet/racks in Dispensed Quarantine.
- Keep dispensed raw materials properly with batch wise segregation. Confirm that “Dispensed Raw Material” label is affixed on dispensed materials to specify the product & batch number.
- Temperature/humidity of Dispensed Quarantine shall be 25°C ± 2°C / NMT 55%.
- Whenever production person needs the batch for processing, production person will inform to IPQA Officer/ designee. Production personal & IPQA Officer/ designee shall verify the material & allow to transferring in process area.
- Material will be transfer to processing area through material airlock on S.S. Trolley.
- After receiving the dispensed materials in process area, IPQA & Production Personnel verifies the material & cross check the weight of all the dispensed materials against the BMR and allow for batch processing.
- During verification, if any material is found miss or short/excess quantity then inform immediately to QA & Production In-charge for necessary.
Return of online Rejected Dispensed Raw Materials.
- During the Raw Material verification or in-process stage if found any discrepancy in the Raw Material (colour variation, black particles etc.) or any other non-compliance with the prescribed parameter inform to Head Production, Head QA & Head Warehouse.
- Segregate the online Rejected Raw Material.
- After the final approval from the QA Head/Designee material can be return to Warehouse Department.
- Production personnel record & weight the qty. and fill the online rejection in ERP system & mention the details in online rejection (OLR) Item Name, Item code, UOM, AR No., Issued Qty., Rejected Qty., Exp. date, Remaining Qty., OLR Qty. & Remark.
- Production personnel print the hard copy of Online rejection & get it signed from Production Head, QA Head & Warehouse Head.
- Affix “Online Rejection” label on the Raw Material. Hand over the hard copy of online rejection along with the online rejected Raw Material to Warehouse Department