SOP on Destruction And Disposal of Media Filled Vials

October 16, 2016January 13, 2024 Pharma Editor

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)
Date	Qty.Of vials(Nos.)	Done by	Checked by	Qty.Of vials(Nos.)	Destruction Done by	Checkedby	Verified by(Q.A)

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

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