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 |