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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

 

 

 

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