SOP for Review and Change Control of Formats

SOP for Review and Change Control of Formats

  • To lay down the procedure for review and change control of formats originated through Standard Operating Procedures (SOPs).
  • This procedure is applicable for review and change control of formats in the instances, where only the respective format(s) required to be reviewed, with out revising the SOP  for better documentation practices.
  • Personnel of concerned department to initiate the Change Request Form ((CRF) Annexure -1
  • Head  of concerned department to review and approve the CRF
  • Head – Quality Assurance (QA) to approve or reject  the proposed change(s) and  to ensure compliance
  • Officer – Documentation to complete the post approval requirements.
  • When ever  a  change  becomes  necessary or desirable to the formats of  any SOPs  of the user department,  the concerned personnel of the department, shall raise a  CRF outlining , the proposed  change(s) and the reasons for change(s), attach supporting documents, if any and  forward  to  the Head of the department.
  • Head of the department shall review and approve the change, if acceptable  and forward  to Head – QA with his comments.
  • Head – QA shall review the change(s) and approve the change(s), if acceptable  and forward to Officer – Documentation, for implementation.
  • Officer – Documentation shall take the final print of the format and allot the revised format number for the new format.
  • Officer – Documentation shall assign effective date for the revised format, mention  effective date on the specimen of the revised format as well as CRF and file the original CRF in ‘File for CRFs’.
  • Officer – Documentation shall take number of copies of the new format as required from the SOP issue register and he shall replace the old formats with new formats in the respective SOPs.
  • Officer – Documentation shall reconcile the superseded formats and destroy.
  • The superseded format of the Master copy shall be stamped as ‘OBSOLETE FOR REFERENCE ONLY’ and retain in the same SOP.
  • Forms and Records (Annexures)
  • Specimen format of “Change Request Form” – Annexure 1.
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality
  • History
    Date Revision Number Reason for Revision
    00 New SOP

Annexure 1

Specimen format of “Change Request Form”

Initiated by : Date : Department :
Format No. :
Format Title :
Proposed change :
 Reasons for change :
Comments of Department Head :
Change(s) acceptable: Yes No Sign.:        Date:
(Put Ö mark in appropriate box)
Comments of Head – QA :
Change(s) Approved:  

     No Sign.:        Date:
(Put Ö mark in appropriate box)
Other connected SOPs (Nos.) :
Superseded format(s) was replaced with the new format and superseded format(s) destroyed.
Stamped master copy of the superseded format with ‘OBSOLETE FOR REFERENCE ONLY’

in the respective master copy of the  SOP.

Effective date :
Officer – Documentation (Sign.) : Date :  



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