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SOP for Receipt of Raw and Packing Material

Objective
To lay down the procedure for receiving Raw and Packing Materials.

Scope
This SOP applies to all Raw and Packing materials received from the warehouse Department at PharmaInfo Ltd.

Responsibility
Store Executive/Officer

Accountability
Head of Department

Procedure
  • Security personnel will receive and make entries in the ‘Security Register for incoming RM/PM’ and will stamp at the backside of the Invoice / Delivery Chalan with the serial number, date, and signature.
  • The security personnel will inform the concerned warehouse personnel regarding the receipt of the material.
  • Warehouse personnel will verify the following against the purchase order and delivery Chelan / invoice.
  1. Name of material
  2. Quantity of material
  3. Delivery Location
  • The material will be unloaded from the vehicle under the supervision of warehouse personnel to the material receipt area.
  • The Warehouse personnel shall perform checking for received material in terms of physical appearance as per SOP.
  • The received materials shall be stored on pallets.
  • The receipt of each Raw and Packing Material is intimated by security.
  • Before unloading inspect the vehicle for cleanliness.
  • Each delivery of Raw and Packing Material should be examined visually while unloading, such as:
  1. Proper labeling of each container, and also checking the intactness of the container.
  2. Match information on outer shippers or packs as mentioned in the Delivery Challan.
  3. If Material is received in Damage / Breakage / Leakage or not in intact condition, such container is to be segregated from other materials and kept aside appropriately.
  4. Record the discrepancy in material discrepancy note and inform to Head of QA & QC and take necessary action as instructed by the Head of QA & QC.
  • Each container, bag, and packet should be cleaned from the outside by a vacuum cleaner/dry lint-free cloth in the receiving bay.
  • At the time of unloading Raw/Packing material, it should be crossed verified with the Invoice / Delivery challan and must be checked physically for the following points for its correctness and approved vendor list.
  1. Name of Material.
  2. Certificate of Analysis (COA)
  3. Purchase Order
  4. Packing List
  5. Batch No.
  6. Mfg. Date/Expiry Date, /Use before date
  7. Quantity per packet/Container
  8. Net. Weight, Gross Weight, Tare Weight.
  9. Description of the material grade/ pharmacopeia status, and quantity in purchase order tallies with that mentioned in the delivery document.
  10. Storage condition on a pack (container/Polybag/box etc). If the above document is not received with the consignment, immediately inform to purchase dept.
  • After de-dusting store person shall shift the material to the staging area for physical verification.
  • Physical verification for actual quantity is carried out for all RM & PM.
  • For packaging materials, random verification will be performed to check the correctness of the quantity mentioned on the label by the party which will be mentioned in the physical verification record.
  • Deface the approved label of the manufacturer on the container, with a black marker pen.
  • Transfer material to the quarantine area. If the storage condition of the material is below 25°C transfer it to RM Store.
  • Give the acknowledgment to the transporter; Record all the details in the Material Inward Register (RM/PM).
  • Prepare GRN and send to Quality Control Department for request Materials Analysis.
  • Raw Material GRN to be made batch-wise and for Packing Material GRN is to be made Challan wise and product-wise.
  • Affix the “QUARANTINE” Label on each & every container for all Raw Materials and ensure that the manufacturer label or the name of the product is not covered by the quarantine label.
  • Affix quarantine labels 100% on Printed Aluminum Foils.
  • For all other packing materials affix a 25% quarantine label of the total received packs. If more than 100 packs are received, affix 25 nos. quarantine labels to the consignment. The remaining containers will be identified with batch no.
  • A sampling of Raw Materials and Packing Materials will be done by Q.C.
  • After sampling, Q.C. Dept shall put sticker as “SAMPLED” adjacent on the quarantine labels of sampled containers.
  • After completion of the analysis. QC person will affix the “APPROVED” or “REJECTED” label on the “QUARANTINE” label.
  • Transfer the material to respective stores after QC analysis:
  1. If the material is approved by the Q.C. department, Transfer the material to the designated approved storage area.
  2. If the material is rejected by the Q.C. department, Transfer the material to the rejected room under lock and key.
  • All Raw Materials should be stored on pallets or racks in an orderly fashion to permit batch segregation and First in First out the stock rotation.
  • All “Approved” packing material product labels shall be stored in their respective lockers under lock and key. Ensure that one locker has only one type of label.
  • In case of more than one lot / A. R. No., pack the labels in separate poly bags and arrange FIFO wise in the respective locker.
  • Store the “Approved” aluminum foil in the foil storage room under a controlled temperature.
  • In the case of the raw material having specific storage conditions, Quarantine and approved Materials are kept segregated in a specified area.

Precautions
  • Store all goods on pallets item-wise and batch-wise.
  • Keep some distance between the wall & material to cleaning can be done easily.

Abbreviations
SOP – Standard operating procedure
QA – Quality assurance
QC – Quality control

Annexure
Nil

Revision History
Nil

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