Types and Procedure of Change Control : Pharmaceutical Guidelines

Types and Procedure of Change Control

Learn the procedure to handle the Change Control in Pharmaceuticals - Major Changes and Minor Changes.
1.  The initiating department shall initiate the change as per the change control format no.
2.  The initiating department shall furnish the details very clearly in the form for present process/use, proposed change, Justification & impact analysis and acceptance criteria.
3.  The initiating department shall also define changes as major or minor based on product quality or its impact on safety, health and environmental aspects. Some of the major and minor changes are listed below: -

3.1  Major Changes

For a substance of chemical and microbiological quality evaluation.
•  Addition or deletion of a step or addition of an alternative/new step in the formulation manufacturing process.
•  Addition of a new manufacturing site with modification of the formulation manufacturing process described in the original dossier/document.
•  Change in input quantities of formulation manufacturing process.
•  Changes in the quality of raw material(s) or key intermediate(s) used in the formulation manufacturing process.

3.2  Minor Changes

•  Change in the administrative references (name/company name, address) of the certificate holder.
•  Change in the references (name/company name, address) of the manufacturing site.
•  Change or updating of the methods of analysis used to test the substance.
•  Change in the specifications of the substance.
•  Change in supplier of starting and packing material.
•  Change in the batch size.
•  Addition of a new manufacturing site in the same site as described in the original dossier.
•  Change in the documents like SOPs etc.
4.  The Initiating department shall forward the proposal as per the requirement to Formulation & Development Department for comments and clearance.
5.  After giving comments/clearance, Formulation & Development shall forward the change control form to Quality assurance department.
6.  On receipt of Change control form from F & D department, QA shall assign the Change control number as per the procedure given below:
Assigning a change control number
-  Each change control number contains seven digits.
-  First two digits represents change control code.
-  Third, fourth and fifth digit represent sequential change control No. (001 to 999)
-  Sixth and seventh digit represents last two digits of the current year. (e.g.01, 02, 03…...99).
For example, following change control no is decoded as explained.
CC-001/ 13.
CC = Change control code.
001= Sequential Change control Number (001, 002, 003…………..999). 
03= Current year 2013 (Last two digit of current year)
7.  QA shall enter the details of Change in the Change control register.
8.  QA shall evaluate the feasibility of the change and forward the change control form to Regulatory affairs, if required.
9.  Regulatory affairs shall evaluate the change in terms of any need to inform customer or any updation in dossiers etc. and forward the change to Site Quality Head.
10.  Site Quality Head shall receive the comment from all the concerns and takes the decision of approving or rejecting the change.
11.  On completion of the total procedure, QA shall formally enter the status in Change control Register and close the Change control Procedure.
12.  Put the stamp of ‘ OBSOLETE COPY’ on the old documents, where every this change control procedure is applicable.

                                                               Change Control Form
Initiating Dept
Change Control No.
Manufacturing Date
Implementation Date
Present Process/Use*

Modification: Major/Minor                                        
Proposed Process/Use*

Justification/Impact of Change*
Supporting Data(If Required)

       Enclosed/Not Enclosed
Accepted Crieteria

           Signature: ________________                          ___________________
                       (Officer/Executive/Designee)            (Head – Initiating Department)
                   Date: _________________                         ____________________         

Comments from F&D Department*(if required)
Comments from Quality Assurance Department*
Regulatory Notification / approval
           Required / Not Required

Type of analysis to be carried out (if any extra analysis is required, give details):

Subsequent Stages
Will be controlled/Not controlled
Validation Status
Will affected / not affected

Manager - QA
Comments from Regulatory Affairs Department*(if required)
Proposed Change is recommended/ Not recommended
Manager – RA
Comments from Engineering Department* (If required)
Manager - Engineering

                                                                                                                            Authorised / Not authorised
Signature:     Plant Head
Site Quality Head
*Whenever applicable, append supporting documentation.                                   
Change Control Record

Change Control no.
Product / Document
Details of Change
Date of Implementation

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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