- To lay down a procedure on destruction and disposal of media filled vials.
- This SOP is applicable for destruction and disposal of media filled vials.
- Production officer / Executive shall be responsible for follow the procedure mentined in this SOP.
- Production Head and QA head shall be accountable for the compliance of SOP.
- SOP : Standard Operating Procedure.
- QA: Quality Assurance
- PD: Production Department
- Inspect each vial after completion of 14 days of incubation for any microbial growth.
- Separate the contaminated and uncontaminated vials.
- Send the contaminated vials to Quality Control Department for further microbiological testing / Investigation.
- Take authorization from Quality Assurance Manager for the disposal of media filled, uncontaminated vials.
- Steam Sterilize the vials at 122 ± 1°C for 25 minutes.
- Crush the autoclaved vials and bury them at the specified area.
- Maintain the record of destruction.
- Forms and Records (Annexures)
- Destruction and Disposal Record of media filled vials – Annexure-1
- Authorization record for media filled vials Destruction – Annexure-2
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
Date Revision Number
Reason for Revision
– 00 New SOP
Destruction and Disposal Record of media filled vials
B.No. Trial Taken on:
|Steam Sterilization Details||Destruction and Disposal Details||Verified by(Q.A)|
|Qty.Of vials(Nos.)||Done by||Checked by||Qty.Of vials(Nos.)||Destruction Done by||Checkedby|
Authorization record for media filled vials Destruction
|Qty. of vials (Nos.)||Trial taken on|
|Head QA||Plant Head|