SOP On Change Control In pharmaceutical company

SOP On Change Control In pharmaceutical company

  • A  procedure to ensure that no changes  are  made in   any    approved    pharmaceutical  product’s, manufacturing    process, GMP   related equipment / facility / utility, computer system, Standard Operating  Procedures (SOPs), Standard  Cleaning  Procedures (SCPs), Master Production Records, specifications, standard test procedures, vendor of raw materials and Primary / Printed packaging  materials, packaging  and  labeling  until the requested change  is   reviewed,  approved and deemed effective by Change Control Committee.
  •  Change  control  committee  consists of   Head of Quality Assurance   Department, respective department   head   requesting the  change and  other  Heads of concerned departments which may be affected by the change.
  • Head of Quality Assurance Department to ensure compliance.
  • Whenever  a  change  becomes  necessary or desirable the concerned Officer prepares   a  “Change   Request  ” (CR)  (annexure-1)   outlining   the proposed  change and the reason for change, attach supporting documents, if any and  forward  to  the department head.
  • Note :Changes covered by a “Change Request” may include, but are not limited to the following:
  • Changes requesting an additional or alternate source of raw materials.
  • Changes in manufacturing procedures.
  • Change in product colour, shape and size.
  • Change in packaging and labeling.
  • Changes to process and/or testing equipment.
  • Changes to cGMP facility or cGMP facility utilities.
  • Changes to computer system used for cGMP purposes.
  • Changes to Master Production Records
  • Changes to Specifications.
  • Changes to Standard test procedures and General test procedures.
  • Changes to SOPs and SCPs
  • Changes to Registration dossiers etc.,
  • The initiator of the Change Request  (CR) shall mention the type of change requested, the respective document reference number if change proposed in an approved document, and briefly summarize the proposed change and reasons for change in the respective columns on the CR, and forward to Department Head.
  • The  Department  Head  shall  enter his comments under the column for Department Head  and forward the CR to the Head of Quality Assurance department (change control coordinator) for his comments.
  • The Change Control Coordinator or his designee shall assign a number to the request and enter  that  number  and  a  brief description of the proposed  change with the date received into the “Change Control Request  Log” (annexure-1).The Change Request  Number shall consist of nine characters.
  • The  first  two  characters  are  department  codes indicating the department from which the Change Request Notice has originated. The department codes are given in Annexure-2
  • The third character is alphabet ‘C’ denoting Change Control.
  • The next three characters are serial numbers starting from 001 on every new year (from 1st January).
  • The seventh character is a ‘/’ (slash).
  • The last two characters are numericals indicating the year.
  • The first change request notice raised in the year 2017 by QC department shall be numbered as QCC001/17.
  • The  Change  Control  Coordinator shall  forward the  Change  Request  with  comments  to other Heads of the concerned Departments  which may be affected by the change may call for Change Control Committee Meeting. The Change Control Committee members shall review the Change Request  and decide on accepting or rejecting the request based on the comments received   and appropriate regulations, Industry practices and cGMP compliance.
  • The members of the Change Control Committee shall evaluate the Change Request  with respect to aspects of Validation, Regulatory approval, Stability studies, etc.
  • The members of the Change Control Committee shall be unanimous in accepting or  rejecting a Change Request . In the event of any disagreement, the change control coordinator may call for a change control committee meeting.
  • The Change Control Committee members shall sign and forward the Change Request to the Change Control Coordinator with their comments.
  • The Change Control Coordinator shall compile the summary of Change Control Committee comments, and whether the change request is approved or rejected, he shall mention the same in the respective columns on the CR.
  • The summary compiled on the CR shall be entered in the Change Request Log under the column for “Remarks about proposed change” and whether CR is approved/rejected in the respective column.
  • The initiating department shall be communicated whether the CR is approved or rejected, by the change control coordinator.
  • If the change request is accepted by the committee members and Validation/Regulatory submission / Stability  testing / Customer notification/Training etc., required, the Change Control Coordinator shall coordinate with respective Head of Department to complete the same.
  • After  fulfilling  the  above  requirements, the Change  Control  Coordinator  shall review  the  completion  of  the  proposed  change  and  assign effective date for implementation.  The same shall be informed to the initiator and other concerned heads of departments.
  • The effective date assigned on the CR shall be entered on the Change Request  Log in the column for ‘Effective date of change’.
  • Approved and completed change request notices along with other supporting documents shall be filed in the “File for change request notice” kept in QA Office.
  • Any additional changes proposed which are to be included after a CR is approved, shall be written on the annexure for change request notice  and send for approval  to the concerned members of the change control committee.
  • Head Regulatory Affairs or his designee shall inform or keep the customer notified of the relevant changes, if required and wherever applicable.
  • Forms and Records (Annexures)
  • Specimen format of “Change Request” – Annexure-1.
  • List of Department Codes – Annexure-2.

  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality
  • History
    Date Revision Number Reason for Revision
    00 New SOP




S No. Change Request Initiator Proposed change Remarks about Approved/ Effective date
Notice Number Dept/Area proposed change Rejected of change



List of Department Codes

Quality Assurance – QA
Quality  Control – QC
Research & Development – R&D
Analytical Laboratory Development – ALD
Regulatory Affairs – RA
Production – PD
Pilot Production – PP
Production Planning – PL
Training – TR
Engineering – EN
Warehouse – WH
Materials – MT
Administration – AM
Information Technology – IT
Accounts – AC
Safety – SF
Novel Drug Delivery Research -NR
Bio Analytical -BA
Validation -VD



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