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Submission of new SOP and changes to existing SOP

  • OBJECTIVE :   
  • To provide a system for initiating a new SOP and to update an existing SOP.
  • RESPONSIBILITY :
  • The Department Head/Section In charge shall ensure that all SOPs pertaining to their department are prepared/updated and routed for approval.
  • Procedure :            
  • Submission of new SOP :                
  • The request for a new SOP shall be initiated by the operating executive of respective department.
  • The initiator of the SOP shall prepare a legible copy of the proposed SOP and write “New SOP submission” at the top of the proposed SOP.
  • The initiator shall forward “New SOP submission” to the Department Head/Section Incharge.
  • The Department Head/Section Incharge  shall have the “New SOP Submission” routed to Department Head/Plant Head, Q.A. Manager and Division Head with comments.
  • The approvers shall signify their agreement or disagreement with comments by signing with date on the “New SOP submission”.
  • A disagreement  response  from  any  one  of  the approvers shall stop any “New  SOP  Submission” until all approvers come to an agreement with the proposed new SOP.
  • A disagreement response requires that the approver disagreeing shall discuss with   the   person   who  initiated  the  new  SOP  and  explain  the  reason  for disagreement and the possible remedies to gain the approval.
  • If the “New SOP Submission” is approved, QA Manager shall have the SOP printed on SOP format.
  • QA Manager shall issue the SOP, approved and authorised in accordance with SOP  (SOP on SOP).
  • Submission of changes to existing SOP :                    
  • The person requesting the change shall :
  • Hand write the changes requested on a separate sheet “Change Request” and attach the same to the most recent revision of the SOP.
  • Sign and date the change request.
  • Submit the change request to the Department Head/Section Incharge.
  • The Department Head/Section Incharge shall have the “Change Request” routed  to  Department Head/Plant Manager, Q.A. Manager and Division Head with comments.
  • Department  Head/Plant Manager, Q.A.Manager  and  Division Head shall individually review the requested change(s), taking into account all aspects that will be affected by the change(s).
  • The approvers shall signify their agreement or disagreement, with comments by signing with date on the “Change request” sheet.
  • A disagreement response from any one of the approvers shall stop any “Change  Request” until  all  approvers  come to an agreement with the requested change(s).
  • A  disagreement  response  requires  that  the  approver disagreeing shall discuss with the person who initiated the changes and explain the reasons for disagreement and the possible remedies to gain the approval.
  • If “Change Request” is approved, Q.A.Manager  shall have the changes made to SOP and print the same on SOP format.
  • Q.A.  Manager  shall  issue  the   new   SOP, approved   and   authorised  in accordance with the SOP (SOP on SOP) showing the recent revision number.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number Reason for Revision

     

    00 New SOP

     

 

 

 

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