Genetica Laboratory Pvt. Ltd.

Motisar, Bara, Nepal

STANDARD OPERATING PROCEDURE

SOP NO.: GL/QA/SOP/A-108

TITLE: DISPOSAL OF REJECTS DATE: 30/07/2010
EFFECTIVE DATE:
01/082010
SUPERCEDE SOP: New
DATE: NA
DEPARTMENT: QUALITY ASSURANCE
Page 1 of 1
REVIEW DATE:30/08/2012

1. OBJECTIVE: Describe the procedure for disposal /Destruction of Rejects in the factory:
2.RESPONSIBILITY: PHARMACIST-QA
3. ACCOUNTABILITY: QA MANAGER
4. PROCEDURE :

1. Rejects means all Raw Materials, Packing Materials, Finished Products, Intermediate and
Bulk. Materials rejected by QC or wastage from production
2. All rejects should be clearly labeled by QC as “Rejected” and store in Rejected Material
Storage Area.
3. Destruction is carried out as per instruction in the destruction memo and recorded in it.
4. Production Manager authorizes destruction Memo prior to destruction.
5. Destruction Memo includes instruction for destruction of the material.
6. Quality Control Manager decides instruction for destruction as per the material concerned. A
suitable method to destroy the material is selected in the most environment friendly manner.
7. For most of the excipients and relatively harmless chemicals, intermediate, bulk and finished
products dispersion/dissolution in water, treatment with acid / alkali or other suitable chemical
agents if required and to throw the material in a soak-pit is preferred.
8. Printed Packaging Materials reject call for destruction by fire (Incineration).
9. If finished products are to be destroyed, they are first of all defoiled and the bulk and the
packing materials destroyed separately.
10. Destruction is supervised and evidenced by Authorized.

PREPARED BY CHECKED BY APPROVED BY

SIGNATURE
DESIGNATION/
PHARMACIST-QA QC MANAGER QA MANAGER
DEPARTMENT
DATE
 Genetica Laboratory Pvt. Ltd.
Motisar, Bara, Nepal
STANDARD OPERATING PROCEDURE

SOP NO.: GL/QA/SOP/A-108

TITLE: DISPOSAL OF REJECTS DATE: 30/07/2010
EFFECTIVE DATE:
01/082010
SUPERCEDE SOP: New
DATE: NA
DEPARTMENT: QUALITY ASSURANCE
Page 2 of 1
REVIEW DATE:30/08/2012

1. OBJECTIVE: Describe the procedure for disposal /Destruction of Rejects in the factory:
2.RESPONSIBILITY: PHARMACIST-QA
3. ACCOUNTABILITY: QA MANAGER
4. PROCEDURE :

PREPARED BY CHECKED BY APPROVED BY

SIGNATURE
DESIGNATION/
PHARMACIST-QA QC MANAGER QA MANAGER
DEPARTMENT
DATE