SOP For disposal of short expiry raw material is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

This procedure has been established to provide guideline for the disposal of near to expiry raw materials (sterile powders / pellets) and destruction of expired raw materials.

SCOPE

This SOP is applicable to Warehouse and Quality Assurance Departments.

RESPONSIBILITY 

Q.A Officer

ACCOUNTABILITY

Manager Quality Assurance

PROCEDURE

Incharge Raw & Packing Material section, at the end of each month, will prepare inventory report through MIS of near to expiry raw materials: Non-Sterile actives & all the excipients with less than 3 months remaining shelf-life, and sterile raw materials and pellets with less than 1 year shelf-life.

The report will reflect Raw Material Name, Mfg. Date, and Expiry Date & Quantity left and will be forwarded to Incharge Quality Assurance for necessary advice. 

In case Incharge Quality Assurance advises the destruction of the material on expiry the same will be forwarded by Warehouse department to Procurement / Finance Departments for information and comments. 

Sterile Powders/Pellets

In case of sterile powders / pellets report will be forwarded to Sales Director through Finance Manager. Finance Manager will seek instructions from Sales Director/Executive Director. 

If Directors advise to destroy or dispose off the left material, if any, it will be disposed off immediately as per the instruction or destroyed after expiry as per policy / procedure.

If Sales Director agrees to market the product with remaining shelf life of about 6 months to 1 year and the area is available for production, the product will be manufactured immediately and dispatched on priority as per sales advice.

In the light of instructions / comments from Sales Director and Incharge Quality Assurance, Incharge Raw & Packing material store, after getting approval from Plant Manager on prescribed format, will arrange to destroy the expired raw material.

Destruction Procedure

Raw material will be dissolved in water followed by addition of acidic or alkaline solution, as required, to neutralize the solution. After neutralization, solution will be discarded in safety tank in prescribed manner.