To lay down a standard procedure for Disposal of Raw Material, Semi Finished Sample, Finished Product, Stability Sample and Packing Material after Analysis.
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.
Officers / Executive – Quality Control shall be responsible for complies of this SOP
Manager- Quality Control And Head QA Shall be accountable for Compliance of this SOP.
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.
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:
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