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Change Control Related Pharma

This document outlines a change control process to ensure that all changes to procedures, materials, methods, equipment, and software are properly documented, approved, validated and traceable. It defines different types of changes including temporary, permanent, major and minor changes. For each type of change, it provides details on documentation and approval requirements. It also includes a classification of typical changes and the recommended supporting studies required for different changes. The overall goal is to have a formal system to review all proposed changes that could impact quality.

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Saurabh Raja
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3K views3 pages

Change Control Related Pharma

This document outlines a change control process to ensure that all changes to procedures, materials, methods, equipment, and software are properly documented, approved, validated and traceable. It defines different types of changes including temporary, permanent, major and minor changes. For each type of change, it provides details on documentation and approval requirements. It also includes a classification of typical changes and the recommended supporting studies required for different changes. The overall goal is to have a formal system to review all proposed changes that could impact quality.

Uploaded by

Saurabh Raja
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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CHANGE CONTROL

A process which ensure that changes to procedures , materials , methods , equipment , and software
are properly documented , approved , validated and traceable .

change control
A formal system by which qualified representative of appropriate disciplines disciplines
review proposed or actual change that might affect the validated status of facility ,system,
equipments or processes .

Type Of Changes :
1. Temporary
2. Permananet
3. Major
4. Minor
Temporary change
A change (departure from any established procedure /system/process)initiated for the evaluation
of
Proposed procedure / system process, which has been taken with prior approval to achieve the
desired output, allowed for one time change and limited to a particular batch . for example change
in batch size , manufacture equipment , etc
Permanent change :
A change initiated based upon scientific rational or historical GMP date or date generated through
temporary change
major change
changes , proposed for improvements to process, materials, product and procedures which may
have impact upon the identity , quality , purity , strength , stability , safety , and efficacy or physical
characteristic of product , notification to agency required .
minor change :
change , which does not have impact on the quality attributes like identity , quality , strength ,
stability ,safety , efficacy or physical characteristic of the product .

change control are divided into two types :


1 permanent
2 temporary
The change control approval or rejection process shall require to be completed within 30 working
days from the date of initiation of the change control .
Change control preferably closed within 90 working days after Head QA approval .
If change control is not closed within specified timeline , initiator shall raise ‘ period extension
request ‘ as per sop . initiating department Head shall review the extension request and write
justification for delay with impact assessment . QA shall assess the impact fo delay in action
completion and approve / reject the period extensions request . period extension shall be allowed
for two times only . after this
New change control trending shall be carried out monthly
CLASSIFICATION OF TYPICAL CHANGES
THYPES OF CHANGE CRITICA MAJOR MINOR
L
Change in systems 
Change in manufacturing formula /process/ new product  
Change in expiry (related to stability )  
Change in critical raw material / solvent  
Change in specification and test method  
Change in SOP for addition / deletion  
Change in equipment 
Modification in critical equipment 
Modification / up gradation in facility 
Change in stability program  
Change in key raw material source of supplier 
Change in storage conditions 
Change in primary packing material 
Change in secondary packing material 
Change in packing style 
Change in printed text on label 
Change in manufacturing location / site  
Change in manufacturing batch size  
Change in packing batch size 
Change in control systems i.e computers , date collection 
Formats and internal labels 
Deletion of a product 

Note : The list can be elaborated base on practical changes occurring at the locations .

Product change :
Change in key / solvent , BOM , process parameters , in-process control , pack style , packing
material , introduction of new product etc .
Engineering change :
Change in facility design , equipment type , maintenance parameters , utilities .
System change :
Change in software / firmware or its configuration etc .
Documentation change :
Change in SOP, STP , Document control procedures etc .
RECOMMENDED SUPPORTING STUDIES FOR CHANGE (S)
Type of change Recommendations
Change in systems Training , change in relevant documents ,
and / or validation wherever required .
Change In manufacturing Validation of three consecutive batches , with
Formula / process/ new product stability studies , method validation ,
specification , STP , cleaning validation .
verification in facility . information and pre-
approval from customer/ regulatory
authorities (as applicable)
Change in specifications Stability studies on the changed specification
dossier updation
Change in test methods Analytical method validation , updating of
TDS, Registration dossier updation ,

Change in sop for addition / deletion of Training , change in relevant documents .


instructions/ formats /labels
Change in expiry Stability studies , change in relevant
documents , intimation to concemed
departments . registration dossier updation.

Change /modification in equipment / new Equipment qualification ,SOP preparation,


equipment training , equipment list updation
Change made for marketing authorization Process related / system related
Modification /up gradation in facility . Facility qualifications ,SMF update
Change in stability program Stability studies in change conditions
Change in critical raw material source Vendor approval as per SOP
Change in storage conditions Stability studies in change conditions , change
in relevant documents / labels
Change in primary packing materials Stability study , change in relevant documents
/BPR , specification updation,.
change in printed text Change in relevant documents / BPR.
Intimation to concerned departments .
Change in manufacturing batch size, Partial validation of three consecutive batches
manufacturing site/ locations , accelerated /long term stability studies
depending on the change .
Change in control system i.e. computes , Validation of the new control system .
configuration of software/firmware , etc

Note : this list is not exhaustive and can be extended based on practical change at the locations

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