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SOP on Destruction And Disposal of Media Filled Vials
- Objective:
- To lay down a procedure on destruction and disposal of media filled vials.
- Scope
- This SOP is applicable for destruction and disposal of media filled vials.
- Responsibility
- Production officer / Executive shall be responsible for follow the procedure mentined in this SOP.
- Accountability
- Production Head and QA head shall be accountable for the compliance of SOP.
- Abbreviations
- SOP : Standard Operating Procedure.
- QA: Quality Assurance
- PD: Production Department
- Procedure
- 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
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision
– 00 New SOP
Annexure-1
Destruction and Disposal Record of media filled vials
B.No. Trial Taken on:
Date |
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 | ||
Annexure-2
Authorization record for media filled vials Destruction
| Batch No.
|
Qty. of vials (Nos.) | Trial taken on |
| Initiated by
(Production) |
Authorized by
(Production Head) |
Approved by | |
| Head QA | Plant Head | ||
