Types and Procedure of Change Control : Pharmaguideline
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  • Jan 31, 2011

    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 of 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 the 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 is given below:
    Assigning a change control number
    - Each change control number contains seven digits.
    - First two digits represent 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/ 18.
    CC = Change control code.
    001= Sequential Change control Number (001, 002, 003…………..999).
    18= Current year 2018 (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 the 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.

    Annexure-1
    Change Control Form
    1.
    Initiating Dept
    Change Control No.
    Stage/Document
    Manufacturing Date
    Implementation Date
    2.
    Present Process/Use*

                                                       
    Modification: Major/Minor                                        
    3.
    Proposed Process/Use*

    4.
    Justification/Impact of Change*
    5.
    Supporting Data(If Required)


           Enclosed/Not Enclosed
    6.
    Accepted Crieteria

    7.
                       
               Signature: ________________                          ___________________
                           (Officer/Executive/Designee)            (Head – Initiating Department)
                       Date: _________________                         ____________________         

    8.
    Comments from F&D Department*(if required)
    Modification:
    Major/Minor
    Date:
    Signature
    Manager-F&D
    9.
    Comments from Quality Assurance Department*
    Modification:
    Major/Minor
    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

                  Date:
    Signature
    Manager - QA
    10.
    Comments from Regulatory Affairs Department*(if required)
    Proposed Change is recommended/ Not recommended
                Date:
    Signature
    Manager – RA
    11.
    Comments from Engineering Department* (If required)
                  Date:
    Signature
    Manager - Engineering
    12.
    Comments


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

    S.No.
     Date
    Change Control no.
    Originating
    Dept
    Product / Document
    Stage
    Details of Change
    Date of Implementation
    Status
    Remarks

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