SOP on Change Control Management

0
4546

Objective

To write a procedure for change control management

Scope

All the changes in documents, facility, equipment, system etc.

Responsibility

Head QA,

Head production

Plant head

Procedure

Change control: Change control is a quality tool and a management to maintain and keep the records of all changes as a history. Changes can be related to facility, documentation, system, equipment, instrument, procedure, layouts and products etc.

Category of changes

Changes can be categorized into three types:-

  1. Minor
  2. Major
  3. Critical
  • Minor change: A change that may not have an impact upon the identity, quality, purity, strength, stability, safety and efficacy or physical characteristic of the product.
  • Major change: A change that may have an impact upon the identity, quality, purity, strength, stability, safety and efficacy or physical characteristic of the product.
  • Critical change: A change that has a significant impact on quality and /or safety of the final product.

 

Initiation of change control

  • Change control should always initiated by user, with whom changes are related. Before initiating the changes an initiating form shall be issued by QA on intimation, in this initiating form all change details shall be detailed.
  • Initiation form when filled, send to HOD, HOD shall check whether changes is to be done or related documents and system are adequate.
  • After approval from HOD, Change initiation form shall send to QA for its approval. QA shall read and study the all, and fix either changes to be done or not.
  • After decision, QA shall categorize the changes and approval shall be as per category.

Numbering system for changes

  1.  All changes shall be numbered as a specific numbering system, as example it shall be CC/XXX/YYYY demonstrated as: CC denotes to change control, XXX denotes to sequential number and YYYY denotes to year,
  2. E.G. CC/001/2017: this shall be the first change control in year 2017.

Approval and review of change control

  • After approval on change initiation form user shall give the intimation for change control form, QA issued the form by assigning change control number.
  • User shall fill the form and make available all documents related to proposed changes; all attachments shall flow with the form to HOD than QA.
  • QA head review the form, as per assigned category, review all attached documents and planned programmes related to changes.
  • After a successful review QA shall approve the form. This shall be entered in log book of change control by QA personnel.
  • In case change control related to regulatory shall be approved by regulatory in consultation with Head QA.

Evaluation and implementation

  • Head QA shall assign the effective date of implementation of the changes and the originating department shall plan for any necessary training and shall update the relevant documents with corrective actions jointly with QA. The status of completion of action shall be mentioned in the change control form by the originating department and shall be forwarded to QA.
  • Implemented change control shall be further reviewed by Head QA. After finding all correct the documents undergoing for changes / revisions shall have revised as per the procedure.
  • Duly approved and closed change control forms are then filed and maintained by QA.

 

Closing of Change control

Change control must be close within a specified period in exceeding a proper justification to be done.

Sample Annexure

  1. Log book change control
Change control No. Originating Department Proposed Change Category of change control CC Approved / Rejected QA Sign/Date Effective Date of Implementation Closed on: (QA) sign/Date

    2. Sample- Change initiation form

Change originated By: Date:
Proposed Change details:
Raised by (Sign & Date):
Comments from HOD:
HOD sign. (Sign & Date):
QA Head comments:
Category assigned Critical Major Minor
Head QA (Sign & Date):

  3. Change control form

Change Control Number   Date                              
Category of Changes               Minor/Major/Critical
Issued By  
Originating Department  
Originator’s (Sign & Date)      
Existing (if necessary, attach details):
Proposed Change (if necessary, attach details):   

 

Change affecting (Tick the appropriate √): Equipment/Instruments/ Process Controls/ Facility/ PM / Documents / RM / batch / Product /Utility/regulatory. In case other ______________

Justification for Change (if necessary, attach details):

HOD Comment ( sign & Date): 
Approval
Evaluation by QA:  QA Head (sign & date):
Date of implementation:
In case of regulatory (forward to regulatory)  Head regulatory (sign & date)
Post implementation comments by QA  Sign & Date
Closed by –QA head   Sign & date

Related articles:

Change control PPT:-http://pharmapathway.com/blog/change-control/

Change control flow diagram:-http://pharmapathway.com/blog/change-control-flow-diagram/

 

 

LEAVE A REPLY

Please enter your comment!
Please enter your name here