SOP for Receipt of Raw and Packing Material : Pharmaceutical Guidelines

SOP for Receipt of Raw and Packing Material

Standard operating procedure to receive the Raw material and Packing material in Stores.


       To lay down the procedure for receiving of Raw and Packing Material.

2.0  SCOPE:

       This SOP shall be applicable for all Raw and Packing material received at Stores Department.


       Store Executive/Officer


       Head of Department


5.1  The receipt of each Raw and Packing Material is intimated by security.
5.2  After receipt of the intimation of the consignment each document should be examined carefully for
•  Whether the material belongs to group companies
•  Delivery Challan
•  Whether the material is received as per Purchase Order
•  Whether the material received from Approved Vendors
•  Cenvat Copy / Bill of Entry
•  Mfg. COA
5.3  Before unloading inspect the vehicle for cleanliness.
5.4  Each delivery of Raw and Packing Material should be examined visually while unloading, such as:
•  Proper labeling of each container, and also check the intactness of the container.
•  Match information on outer shippers or packs as mentioned in Delivery Challan.
•  If Material received in Damage / Breakage / Leakage or not in intact conditions, such container is to be segregated from other material and kept aside with a suitable manner.
•  Record the discrepancy in material discrepancy note and intimate to HOD QA & QC and take necessary action as instructed by HOD QA & QC.
5.5  Each container, bags and packet should be cleaned from outside by vacuum cleaner/dry lint free cloth in receiving bay.
5.6  At the time of unloading Raw/Packing material it should be crossed verified with Invoice / Delivery challan and must checked physically for the following points for its correctness:
•  Name of Material.
•  Quantity per packet/Container
•  Mfg. Date/Expiry Date, /Use before date
•  Batch No.
•  Net. Weight, Gross Weight, Tare Weight.
•  Storage condition on pack (container/Poly bag/box etc). 
5.7  After de-dusting store person shall shift the material in staging area for physical verification.
5.8  Physical verification for actual quantity is carried out for all RM & PM.
5.9  For packaging materials, random verification will be performed for checking correctness of quantity mention on label by the party which will be mention in physical verification record.
5.10  Check the Item Name, Batch No. and Mfg. Name, gross weight, tare weight and net weight of each container. Record the observations in physical verification record.
5.11  Deface the approved label of the manufacturer on the container, with a black marker pen.
5.12  If Mfg. COA is not received with the consignment, immediately inform to purchase dept.
5.13  Transfer material to quarantine area. If storage condition of material is below 25°C transfer it to RM Store.
5.14  Give the acknowledgement to the transporter; Record all the details in Material Inward Register (RM/PM).
5.15  Make the GRN in SAP system in MIGO and send mfg. COA to Quality Control Department.
5.16  Raw Material GRN to be made batch wise and for Packing Material GRN is to be made Challan wise & Product wise.
5.17  Affix “QUARANTINE” Label on each & every container for all Raw Material & Ensure that manufacturer label or name of the product should not be covered by the quarantine label.
5.18  Affix quarantine labels 100% on Printed Aluminum Foils.
5.19  For all other packing material affix 25% quarantine label of total received packs. If more than 100 packs are received, affix 25 nos. quarantine label to the consignment. Remaining containers will be identified with batch no.
5.20  Sampling of Raw Material and Packing Material will be done by Q.C.
5.21  After sampling, Q.C. Dept shall put sticker as “SAMPLED” adjacent on quarantine labels of sampled containers.
5.22  After completion of analysis. Q.C person will affix the “APPROVED” or “REJECTED” label on the “QUARANTINE” label.
5.23  Transfer the material to respective stores after QC analysis:
•  If material approved by Q.C. department, Transfer the material in designated approved storage area.
•  If material rejected by Q.C. department, Transfer the material in rejected room under lock and key.
5.24  All Raw Materials should be stored on pallets or racks in an orderly fashion to permit batch segregation and First in First out stock rotation.
5.25  All “Approved” packing material product labels shall be stored in their respective lockers under lock & Key. Ensure that one locker has only one type of label.
5.26  In case of more than one lot /A. R. No., pack the labels in separate poly bags and arrange FIFO wise in respective locker.
5.27  Store the “Approved” aluminum foil in the foil storage room under controlled temperature.
5.28  In case of raw material having specific storage condition, Quarantine & Approved Materials are kept segregated in specified area.
1)  Store all goods on pallets item wise and batch wise.
2)  Keep some distance between wall & material so as to cleaning can be done easily.


6.1  SOP – Standard operating procedure
6.2  QA – Quality assurance
6.3  QC – Quality control

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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