1.0 Purpose: To lay down the procedure for receiving, handling, and storage of primary and secondary packaging Material.
2.0 Aim: This Standard Operating procedure is applicable to the receiving, handling, and storage of primary and secondary packaging material on the production floor.
3.0 Responsibility:
3.1 The line coordinators shall carry out the process.
3.2 Officers/ Sr. officers shall supervise the process.
3.3 Production Manager for the implementation of SOP.
3.4 IPQA shall be responsible for compliance with SOP.
3.5 Head QA /Designee shall be responsible for the authorization of the SOP.
4.0 Procedure:
4.1 Receiving of primary and secondary packaging material :
4.1.1 All materials are to be received from the warehouse through a static pass box between rooms.
4.1.2 Outer surface of the non-laminated box and other packing material is to be cleaned with a dry mop. The laminated Outer box of the vials, seals, tubes, and rubber stoppers are to be surface sanitized by moping with 70% IPA and disposable lint-free mop.
4.1.3 Check the material before receiving it for the intactness of the box.
4.1.4 All the boxes should be completely intact and free from any adhering particles like dust, grease, and oil.
4.1.5 If boxes are not intact, damaged, crumbled, or dephased they should not be accepted.
4.1.6 Check the approved QC label on each box of material before receiving it.
4.1.7 Check the quantity physically and compared it with the quantity mentioned in the requisition. The verification of quantity as well as item code, specification, etc. of material in the presence of QA before the material is issued to production.
4.1.8 Check the cleanliness of the cage/trolley and the crates in which material is to be transferred.
4.2 Handling of primary and secondary packaging material:-
4.2.1 Clean the trolley and SS pallets.
4.2.2 Transfer the material in the production area on Teflon wheel cage/trolley.
4.2.3 SS Pallets containing material should transfer to primary or secondary packing material storeroom.
4.3 Storage of primary packaging material (Vials, Stoppers & Tubs) :
4.3.1 Store the boxes in an approved primary packing material store.
4.3.2 After shifting the material in the particular area, where it is to be stored, paste the status label on the material or area.
4.3.3 Don’t remove the status label until it is consumed completely.
4.3.4 Shrink wrap the material if more than one product or batch material is present in the same room.
4.3.5 The boxes of the material should be stacked carefully, to a height that can get lifted without using any climbing device.
4.4 Storage of secondary packaging material :
4.4.1 Store the boxes of only approved secondary packing material in the Room.
4.4.2 Follow steps number 4.3.1 to 4.3.5.
4.4.3 All labels (both coded and un-coded) are to be stored in the lockers placed in Room.
5.0 Abbreviations:
HOD: Head of the Department
ID No. : Identification number
No. : Number
SOP: Standard Operating Procedure
PR: Production
QA: Quality Assurance
IPA: Iso Propyl Alcohol
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