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Change Control

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KAUSHIK CHAKRABORTY
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38 views

Change Control

Uploaded by

KAUSHIK CHAKRABORTY
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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CHANGE cONTROL

Definition:
Change control is a systematic approach to managing all changes made to a product or
system. The purpose is to ensure that no unnecessary changes are made, that all changes
are documented, that services are not unnecessarily disrupted and that resources are used
efficiently.
Procedure:
1. The initiating department shall initiate the change as per the change control fornmat
2. The initiating department shall furmish 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 of safety, health, and environmental aspects. Some of the major and
minor changes are listed below:
Major Changes; For a substance of chemical and microbiological quality evaluation.
Addition or deletion ofa 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 offormulation manufacturing process.
Changes in the quality of raw material(s) or key intermediate(s) used in the formulation
manufacturing process.
Minor Changes:
Change in the administrative references (name/company name, address) ofthe
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 ofthe
substance.
Change in supplier and packing material.
of starting
Change in the batch size.
Addition ofanew manufacturingsite in the same site as describedin the original
dossier.
Iumer
Change in thedocuments like SOPsetc.
Key Benefits of Change Control Svstem:
Structuredand consistent approach towards managing change.
Documenting the detailsof change.
Routingof changerequests to appropriate individuals/team for approvals
of
Documentation change approvalsandimplementation.
Maintenance of change history and easy retrieval of information.
Tracking changes effectively and providing an audit trail.
Demonstrate compliance to FDA regulations.

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