SOP storage of secondary and tertiary packaging material.

OBJECTIVE:To provide guidelines for storage of secondary and tertiary packaging materials.

SCOPE:This SOP is applicable for storage of secondary and tertiary packaging materials in the Packaging material store area.

REFERENCE:In house

RESPONSIBILITYStore officer – To store the material as per SOPStore Head – To ensure SOP is being followedQA – To ensure proper implementation of SOP

ABBREVIATIONS

SOP : Standard Operating Procedure

QA : Quality Assurance

PROCEDURE

1. Receive the secondary and tertiary packaging materials (hence forth packaging materials) as per material receiving SOP.

2. Store it in the quarantine/undertest area till approval from the QC.

3. Once released from the QC arrange and keep the materials as follows –

a. Printed labels and cartons- All printed packaging materials are to be kept under lock and key in the dedicated area provided in the Packaging materials store.

– Only authorized personnel can enter in the area.

– If by chance lock and key area is full and cannot accommodate further materials then the printed material is to be kept outside the lock and key room on the racks, following the SOP no. SOP/P/ST/21.

In this case Primary packaging material store itself should be locked and authorized store personnel should accompany the personnel wants to go to that area.

e.g. QC personnel who needs to do sampling.

b. Tertiary Packaging materials – It generally includes shippers and HDPE drums.

– Shippers of different products should be racked separately with labels.

– Racking should be done as per SOP no. SOP/P/ST/21.

4. Store personnel shall ensure 100% release labeling on the packaging materials.

FREQUENCY

Whenever secondary and tertiary packaging material is to be

stored in Packaging material store area.

ANNEXURE

NA