SOP for Handling and Storage of Raw & Packing Material : Pharmaceutical Guidelines

SOP for Handling and Storage of Raw & Packing Material

Standard operating procedure to store the Raw Material and Packing Material in stores quarantine area after receiving the material as per the storage procedure in pharmaceutical industries.


       To lay down a procedure for proper identification, storage & handling of Raw & Packing material.

2.0  SCOPE:

       This SOP shall be applicable for storage and handling of Raw & Packing materials at Stores Department.


       Stores Assistant/Officer


       Head of Department


5.1  After receiving the materials, store person shall unload the materials in staging area and clean the material (container/packs) with the help of vacuum cleaner/dry lint free cloth and transfer the material in designated quarantined storage area after physical verification and affix quarantine label.
5.2  Store person shall record his observation in a Physical verification Record for RM or Physical verification Record for PM.
5.3  When the material is released by QC, QC person shall affix the “APPROVED” label on each container/bags and Store person shall transferred the material in designated approved storage area as per their storage condition.


5.4.1  If raw material storage limit is 2°C to 8°C, transfer the material in cold storage and daily record is maintained.
5.4.2  If material storage limit is below 25°C transfer the material in RM.
5.4.3  If the material storage condition is not specified store the material in RM Store.
5.4.4  If the material is rejected by Q.C. dept. it must be shifted to the REJECTED storage area under lock & key. A logbook of rejected material in this area is to be maintained.
5.4.5  Information of rejection of the materials should be given to the purchase dept.
5.4.6  After dispensing, loose quantity of the material should be closed tightly with nylon thread and shifts it into the original container.
5.4.6  In case temperature of stores exceeds the limit inform to maintenance for rectification.
5.4.7  Rejected raw material shall be sent back to the supplier as per the instructions given by the purchase department.
5.4.8  If rejected material is destroyed in factory premises, prepare the destruction note and follow the SOP.


NOTE: Different packing material to be stored respectively as defined below:

5.5.1  PRINTED LABELS  After Q. C. Approval, keep all printed label products wise / item codes wise in their respective cupboards under lock and key.

5.5.2  PRINTED PACKING MATERIAL  After Q. C. Approval, keep all printed paper packaging material with segregation of item / lot wise on racks / Pallets.

5.5.3  PRINTED / PLAIN ALUMINIUM FOIL/ PVC / PVDC FILM  After Q.C. Approval, keep plain / printed aluminium foil / PVC/PVDC film in Foil storage room.  Ensure that different consignments are physically segregated.

5.5.4  MEASURING CAP / PLASTIC JAR / CONTAINER  After Q. C. approval keeps all above items on the Pallets.  Keep small consignment / leftover quantity on the racks/Pallets.  Issue all packing material as per FIFO basis to production dept.  In case of rejected printed packing material it should be destroyed in factory premises after completing the necessary formalities.


6.1  SOP – Standard operating procedure
6.2  QA – Quality assurance
6.3  QC – Quality control
6.4  FIFO – First in First out

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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1 comment: Post Yours! Read Comment Policy ▼

  1. Dear sir not mention fast crate grn and send to qc then sampling and material transfer to under test area. ...



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