1.0 OBJECTIVE:To lay down a procedure for Dispensing & Issuing of Raw Material.
2.0 SCOPE:This SOP shall be applicable for all Raw Materials which are dispense for Production at Stores Department.
3.0 RESPONSIBILITY:Stores Assistant/Officer
5.0 PROCEDURE:5.1 Production department shall give Bill of Material / Material Requisition Sheet as per Batch Manufacturing Record well in advance to stores department.
5.2 After getting Bill of Material/Material Requisition Sheet from production dept., store person shall check the availability of approved material as per FEFO/FAFO system for the respective batch in SAP.
5.3 If any material found is still lying in under test, the store person shall inform to Q.C. immediately.
5.4 Store person shall transfer all the approved material as per FEFO/FAFO system at dispensing area.
5.5 Before entering in dispensing area, all person shall follow Secondary Gowning procedure.
5.6 Store person shall check and verify all the detail, Material name and code, approved label, A.R. number, Batch No., Mfg. Exp. Date and Retest date (Use before date) before dispensing.
5.7 Store person shall put ‘ON’ the RLAF Dispensing Booth-I & II for 15 minutes before starting the dispensing activity.
5.8 Single product will be dispensed in dispensing area by using both dispensing booth.
5.9 Store person shall check the dispensing area for its cleanliness, as per SOP for “Cleaning of Dispensing Room”.
5.10 Store person shall check the pressure difference on pressure gauge it should be
· Pressure gauge for Pre-filter: 1 to 6 mm of water gauge.
· Pressure gauge for Intermediate-Filter: 3 to 6 mm of gauge.
· Pressure gauge for HEPA filter: 8 to 16 mm of water gauge.
5.11 Store person shall check the temperature & relative humidity in dispensing room before starting dispensing.
5.12 Before starting the Dispensing activity, store person shall ensure that every equipment like containers, scoops are cleaned & dried to avoid cross contamination and also ensure that all the balances are calibrated before weighing.
5.13 After getting line clearance from QA person, start the dispensing activity in presence of Production person and Store person and fill the Dispensing Log Book.
5.14 Production person shall check temperature and Relative humidity and verify once again all the detail on the container, Material name and code, approval label, A.R. number, Batch No., Mfg. & Exp. Date and Retest date (Use before date) in dispensing room before weighing the material.
5.15 If any discrepancy is found, it should bring to the notice of the HOD QA & QC and necessary action is to be taken as per the instructions.
5.16 Store person shall use separate scoops for each material to avoid cross contamination.
5.17 While dispensing, if any material is found for spillage / breakage /leakage inform QA department and to superiors immediately.
5.18 Store person shall weigh the material under RLAF cabinet and shall open the container under RLAF in safe working zone.
5.19 Store person shall weigh one material at a time in double polybags by scoops on balance. Sequence of material issues should be (1) Excipients & Colours & Flavour (2) Active material (3) Colours & Flavour.
5.20 Store person shall weigh the material as mentioned in Bill of material/ Requisition sheet and shall check the Potency of Material if applicable.
5.21 After weighing of material, store person shall mention Gross weight, Tare weight and Net weight and tie the weighed material with Weighing Slip and sign it. Production person shall verify the weight by signing the Weighing Slip.
5.22 Put the UNDER USE (LOOSE QTY.) label on the last used container and mention the quantity leftover on that container, transfer it to the respective approved storage area.
5.23 All issued material is transferred to Day Store (Dispensed Material Storage Area) through pass box along with Original and Duplicate Bill of Material. The packing person shall return the duplicate copy as receipt of material after signing the same to stores dept. for necessary entries.
5.24 After completion of dispensing, store person will put off the RLAF and clean the dispensing room as per SOP “Cleaning of Dispensing Room.” and clean the utensils as per SOP “Cleaning of Dispensing Utensils”.
5.25 AR wise reconciliation shall be done by store person after consumption of respective AR No. and necessary entries shall be done in SAP.
5.26 Store person shall make necessary entry in bill of material and also deduct the quantity in SAP system through (MB1A) movement.
5.27 Store person shall deface empty container/bags and will transfer to scrap yard for further disposal.
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