SOP FOR DISPOSAL OF RAW MATERIAL, SEMI-FINISHED, STABILITY AND PACKING MATERIALS SAMPLES

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1.0)  OBJECTIVE:

To lay down a standard procedure for Disposal of Raw Material, Semi Finished Sample, Finished Product, Stability Sample and Packing                 Material after Analysis.

2.0) SCOPE:

This SOP is applicable for Disposal of Raw Material, Semi Finished Sample, Finished Product, Stability Sample and Packing Material after           Analysis in Quality Control Department.

3.0) RESPONSIBILITY:

Officers / Executive – Quality Control shall be responsible for complies of this SOP

4.0    ACCOUNTABILITY:           

         Manager- Quality Control And Head QA Shall be accountable for Compliance of this SOP.

5.0    ATTACHMENTS:

         Nil

6.0) PROCEDURE:

6.1    Disposal of Raw Material, Semi Finished Sample, Finished Product and Stability Sample:

  • Dispose the samples after 7 days of approval. Store all the approved samples in properly marked   container as per their category. After 7 days dispose the material.
  • After the 7 days of approval, cut the status of sample label of Raw Material, Finished Product, Semi Finished and Stability Sample.
  • Put the sample in container, with labeled “Sample for Destruction”.
  • Lab Assistant shall dispose the sample suitably under supervision of concerned QC Officer.
  • For Capsule, defoil and disperse it with sufficient amount of hot water.
  • For Raw Material/Semi Finished sample, remove the content and disperse it in sufficient amount of water.
  • Finally collected waste material should be transfer to ETP for further disposal.
  • Disposal of Packing Materials:
    • After the 7 days of approval, collect all the excess samples.
    • In case of Printed /plain /Blister Aluminum foil, PVC/PVDC, HDPE cut the sample in small pieces and transfer the piece to waste bin.
    • In case of Label, Leaflet, carton, sticker label, or all printed packing material and corrugated Box, tore it in small pieces and transfer to scrap.
  • REFERENCES:

Nil

  • ABBREVIATIONS:

SOP: Standard Operating Procedure.

QC: Quality Control.

ETP: Effluent Treatment Plant.

PVC: Polyvinyl Chloride

PVDC: Polyvinyl dichloride.

HDPE: High Density Polyethylene

QA: Quality Assurance

9.0    DISTRIBUTION LIST:

Quality Assurance Department

Quality Control Department

10.0  HISTORY OF REVISION:

Version No. Date of Revision Reason for Revision
00 New SOP
01 Periodic Revision
02 Periodic Revision

 

SOPs