SOP for Receipt and storage of raw materials

1.0 OBJECTIVE
To describe the procedure for receipt and storage of raw materials.

2.0 SCOPE
This procedure is applicable to all the raw materials received in the warehouse of (Company Name).

3.0 RESPONSIBILITY
3.1 Operator to perform the operations, as per laid down procedure.
3.2 Warehouse officer shall be responsible to carry out the activity as per procedure.
3.3 Manager, Warehouse shall be responsible to ensure the proper training and implementation of the procedure.

4.0 ACCOUNTABILITY
4.1 Manager Warehouse

5.0 PRECAUTIONS
5.1 Ensure the calibration due date of balance before weighing of receipt materials.
5.2 Ensure the cleanliness of dry cloth used for cleaning of receipt materials.
5.3 To prevent ingress of mosquito within the warehouse, “Material Lock In” or “Material Lock Out” shutter door will be opened only when material receiving shutter door and material dispatch shutter door are closed.
5.4 Ensure that when material receiving shutter door or material dispatch shutter door is Open- “Material Lock In” and “Material Lock Out” shutter door are closed.
5.5 Ensure that all raw materials container are intact during receiving.
5.6 Ensure that material containers are kept in correct position (up side up).
5.7 Ensure that no multiple lot and multiple materials to be kept in a one pallet.
5.8 Ensure that supplier “Approved” label (if any) shall be defaced during receiving time.
5.9 Warehouse officer to ensure that the material is received as per Invoice and Purchase Order.
5.10 Ensure that the material is received from Approved Vendor.
5.11 Warehouse officers ensure that the received materials have at least 50% shelf life by the date of materials receipt at the warehouse.
5.12 Ensure that any discrepancy during receiving, inform to QC/QA and Procurement Department.
5.13 Ensure that all raw materials are stored as per specified temperature limit mentioned in “Storage condition of raw materials”.
5.14 Ensure that materials are shifted from plastic pallets to SS trolley before sampling in the sampling corridor.

6.0 PROCEDURE
6.1 Receipt of raw materials
6.1.1 After arrival of materials transport, Security personnel make necessary entries in the register log book and allow the vehicle to Warehouse with gate entry number.
6.1.2 Delivery man submits consignment document such as Delivery Challan, Commercial Invoice and Certificate of Analysis of the material to warehouse officer and he will check all that documents.
6.1.3 Check purchase order for receipt materials, if the material is received without purchase order than warehouse officer shall inform to Procurement Department and collect purchase order as soon as possible. If the material is received or not as purchase order, warehouse officer shall inform the matter to Procurement Department through mail for further action.
6.1.4 Check Approved vendor list against receipt material, if the material is not received from approved vendor, warehouse officer shall refer the matter to QA and shall wait for their instruction.
6.1.5 Check materials vehicle for its cleanliness and transit condition of the materials. If vehicle cleanliness is not satisfactory, warehouse officer shall inform to QA in presence of the transporter and wait for QA instruction. Such materials shall be kept in ‘Hold Area’ or material shall be returned after consultation with QA and inform to Procurement Department and supplier for necessary action.
6.1.6 After verification of document and vehicle condition, the warehouse officer shall call the operators for unloading the materials.
6.1.7 Operators take the plastic pallets for unloading of material by using Hand trolley and then unload the material on these pallets.
6.1.8 If one material delivery is made up of different batches, each batch must be segregated in separate pallets.
6.1.9 The warehouse officer upon receipt and before acceptance of materials, examine visually every container for correct labeling (including correlation between the name used by the supplier and the in-house name, if these are different), loss of integrity of the packages such as torn bags / wet bags / broken containers or broken seal, container/drum damage, and evidence of tampering or contamination for each delivery.
6.1.10 Check 50% shelf life for received materials, If shelf life found less than 50% by the material received date, warehouse officer raise discrepancy to QA with copy to Procurement Dept. for further action and the material shall be stored in ‘Hold Area’.
6.1.11 The warehouse officer shall fill the ‘Raw material receipt checklist” (FRM No.: FWH/001).
6.1.12 Warehouse officer shall check manufacturer label of every container /bags for material name, manufacturer name, Batch/Lot no. manufacturing date, expiry date as per Invoice and Certificate of Analysis.
6.1.13 In case of any discrepancy warehouse officer fills the ‘Discrepancy Report for Receipt of Material’ in presence of the transporter and also inform to QC & waits for QC instructions. Such material shall be kept in ‘Hold Area’ or material shall be returned after consultation with QC and inform to Procurement Department and supplier.
6.1.14 If the warehouse officer is confirmed that the material is received in good condition with all required documents, then warehouse personnel shall put the stamp and sign on delivery challan and hand over to the transporter/delivery man.
6.2 Cleaning and weighing of the received Raw Materials
6.2.1 Use vacuum cleaner to remove loose dust from all raw material containers. If removing dust is difficult by vacuum cleaner, use dry clean cloth for cleaning of all containers, bags, and boxes etc.
6.2.2 Record cleaning details in ‘Raw Material Container Cleaning Record’ (FRM No.: FWH/034).
6.2.3 The warehouse officer shall cross check “Gross weight” against the manufacturer label of containers by calibrated balances only. Observed weight variation limit is ± 0.5% for active raw materials and ± 1.0% for inactive raw materials except Pregelatinized starch and Microcrystalline Cellulose. These two materials found always excess, so weight variation limit is up to +4.0%.
6.2.4 If “Gross weight” is not declared in the manufacturer label, warehouse officer check gross weight and tare an empty container weight from the observed weight. The empty container shall be from same source, which is received from earlier consignment.
6.2.5 Warehouse officer shall record the weighing details in ‘Weighing Records for Receipt Materials’ (FRM No.: FWH/006).
6.2.6 Warehouse officer shall adjust raw materials receipt quantity through ‘Stock Adjustment Memo’ as per weighing records after QC approval of each consignment (A.R. wise).
6.2.7 If observed weight exceed the weight variation limit, the warehouse personnel shall raise discrepancy report to QC department and inform the same to the Procurement Department for further action.

6.3 MRR Preparation
6.3.1 After checking, cleaning & weighing of the materials, enter the receipt details in ‘Material Receiving log book’ (FRM No.: FWH/007). by assigning distinctive receiving R Number, R – for Raw material for each receipt.
6.3.2 Warehouse officer fill all required information in “Inventory Management System” to prepare Material Receipt Report -RM (MRR) (FRM No.: FWH/008). Then Warehouse office shall take print out MRR for each batch and “Quarantine” labels for each container of received materials.
6.3.3 Affix “Quarantine label” in every containers then keep that material in “Material Lock In” & close the shouter door and make necessary entry in Quarantine label issue and destruction record (FWH/015).
6.3.4 Warehouse personnel enter through change room and open the opposite shutter door of “Material Lock In” and that materials transfer to quarantine storage area of raw materials.
6.3.5 MRR forward to QC department along with Certificate of Analysis and discrepancy report (if any).

6.4 Handling of Discrepancy
6.4.1 Warehouse officer shall fill the ‘Discrepancy Report for Receipt of Material’ (FRM No.: FWH/002) and enter details in the discrepancy log book (FRM No.: FWH/028) with discrepancy serial no and send original copy to QC Department.
6.4.2 After Investigation regarding discrepancy, QC return photocopy of discrepancy report to warehouse with decision/comment by Quality Head, Warehouse officer will make entry in the discrepancy log book and preserve the copy in the separate file. Warehouse personnel handle the discrepancy materials as per QC decision/comment.
6.5 Handling of ‘HOLD’ Materials
6.5.1 In case the received materials are not complying any parameters mentioned in the ‘Raw Material receipt checklist’ (FRM No.: FWH/001) and materials which are initially detect as Hold, shall be transfer to Hold Area. Warehouse personnel shall paste the status label such as ‘HOLD’ (FRM No.: FWH/003) on each box / bag / container / drum etc till the non- compliance is corrected.
6.5.2 If the material is temperature controlled (2-8°c & 8-15°c), then such material shall be transfer to temperature controlled area with Hold label and material to be stored with proper segregation.

6.6 Sampling of Raw Material
6.6.1 On receipt of ‘Material Receipt Report -RM’, Quality Control personnel shall sample the material as per the sampling procedure. Before sampling warehouse officer shift the materials from plastic pallets to SS Trolley.
6.6.2 After completion of sampling the material shall be kept in respective quarantine area with “Sampled Label” (FRM No.: FQC/001) affixing to the sampled containers.
6.6.3 After analysis of the material if material is approved, QC Personnel shall affix ‘Approved’ label (FRM No.: FQC/002) on each pack/container in a cascading manners and Warehouse personnel transfer the material from Quarantine storage area to Approved storage Area.
6.6.4 In case of rejected material, QC personnel shall affix ‘Rejected’ label (FRM No.: FQC/003) on each pack / container. Warehouse personnel shall transfer the material to Rejected area and make necessary entry in ‘Rejected Materials Record’ (FRM No.: FWH/010).
6.6.5 QC shall give duly signed copies of Material Receipt Report -RM (MRR) (Original, Second and Third copy) to warehouse for Released / Rejected materials and fourth copy shall be retained for QC record. In case the material is rejected, QC shall give original copy of ‘Raw material rejection memo (FRM No.: FQC/006) along with MRR to warehouse and forward copy of rejection memo to the Procurement Department for further action.
6.6.6 Warehouse officer shall forward second copy of MRR to Accounts department and third copy to Procurement department along with photocopy of raw material rejection memo (if any) and discrepancy report (if any).Original copy of MRR and ‘Raw material rejection memo’ shall retained by Warehouse.
6.6.7 Procurement Department will inform to Manufacturer/Supplier for such discrepancy and rejection of material after receiving rejection memo and discrepancy report.
6.6.8 If any time any label is peeled off from the container / bag, warehouse in consultation with QC should ascertain the identity and batch details and QC issue & fix the required label on container.

6.7 Handling of MDI Raw Materials
6.7.1 All MDI raw materials will be received and stored following the procedure step 6.1 to 6.5. Only 1,1,1,2-Tetraflurorthane cylinder will be stored in front of Central Finished goods warehouse..
6.7.2 Warehouse officer transfer the material containers to MDI dispensing area for sampling purpose. On receipt of ‘Material Receipt Report -RM’, Quality Control personnel shall sample the materials in the dispensing area of MDI as per the sampling procedure. After sampling material containers returned to Warehouse “Quarantine Area”
6.7.3 After approval materials stored at warehouse approved area. Before manufacturing approved materials container transfer to MDI unit for dispensing as per production requisition. All loose raw material containers will be stored in Material staging room of MDI production area. Raw Materials List is enclosed. (Annexure-X)
6.8 Handling of Temperature controlled Materials.
6.8.1 All temperature controlled materials which requires to be stored at 2-8°c and 8-15°c, are stored in the cool and cold room located in the Warehouse.
6.8.2 Temperature controlled materials are stored segregated way in the cool and cold room with proper labeling – “Quarantine” and “Approved”. In case of space constraint in the cool & cold room, use separator to segregate the material/ batch for same pallet.

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