1.0 PURPOSE
1.1 The purpose of this standard procedure is to establish an effective system for proper management and destruction of expired drugs.
2.0 SCOPE
2.1 It is applicable in Finished Goods Store.
3.0 RESPONSIBILITY
3.1 Director
3.2 Q.C. Manager
3.3 Production Manager
3.4 F.G. Store Incharge
3.5 Account Department
4.0 GENERAL PROCEDURE
4.1.1 The expired returned drug received from marketing office is entered to the store return voucher (QR/028/01).
4.1.2 Then the returned expired drug is entered in Bin Card (QR/007/01).
4.1.3 F.G. Store Incharge prepare the destruction sheet (QR/FG/015/01).
4.1.4 The destruction sheet (QR/FG/015/01) is then approved by Q.C. Manager, Production Manager and Director.
4.1.5 The expired returned drugs are then destroyed in the presence of F.G. Store Incharge, Q.C. Manager, Production Manager as follows:
Sr.#
Dosage Form
Method of Destruction
01
Solid Dosage Form
De-blistering, crushing, drain with the sufficient quantity of water
02
Liquid Dosage Form
Glass destruction, solution drainage with sufficient quantity of water.
5.0 PRECAUTIONS
5.1 Every expired returned drug should be documented.
5.2 Every drug to be destroyed should be placed in a separate identified area.
5.3 Every drug to be destroyed should be kept under lock and key with proper documentation.
5.4 Every activity performed with the expired returned drug should be documented according to the sop strictly.The record of destruction should be maintained properly
