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.

1.0 OBJECTIVE

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.

3.0 RESPONSIBILITY

Stores Assistant/Officer

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 After receiving the materials, store person shall unload the materials in the staging area and clean the material (container/packs) with the help of vacuum cleaner/a 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 transfer the material in the designated approved storage area as per their storage condition.

5.4 STORAGE OF RAW MATERIAL

5.4.1 If raw material storage limit is 2°C to 8°C, transfer the material in cold storage and the 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 purchasing dept.
5.4.6 After dispensing, the 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 information to maintenance for rectification.
5.4.7 Rejected raw material shall be sent back to the supplier as per the instructions are given by the purchasing department.
5.4.8 If the rejected material is destroyed in factory premises, prepare the destruction note and follow the SOP.

5.5 STORAGE OF PACKING MATERIALS

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

5.5.1 PRINTED LABELS

5.5.1.1 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

5.5.2.1 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

5.5.3.1 After Q.C. Approval, keep plain / printed aluminum foil / PVC/PVDC film in Foil storage room.
5.5.3.2 Ensure that different consignments are physically segregated.

5.5.4 MEASURING CAP/ PLASTIC JAR/ CONTAINER

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

6.0 ABBREVIATIONS

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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