CHANGE CONTROL

What is change control

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

CHANGE CONTROL PROCEDURE:

DEFINATION:

Change Control: 

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

Temporary Change:

A change (departure from any established procedure/system/process) initiatedfor 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, manufacturing equipment, etc.

Permanent change:

A change initiated based upon scientific rational or historical GMP data or data generated through temporary changes.

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 the product. Notification to agency required.

Minor Change: 

Changes, which does not have impact on the quality attributes like identity, quality,purity, strength, stability, safety, efficacy or physical characteristic of the product.

Changes are divided into two types:

1) Permanent Change

2) Temporary Change

The change control approval or rejection process shall require to be completed within 30

workingdays 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 No. QAD 098. Initiating department Head shall review the extension request and write justification for delay with impact assessment. QA shall assess the impact of delay in action completion and approve / reject the Period extension request. Period extension shall be allowed for two times only. After this new change control shall be initiated. Change control trending shall be carried out monthly.

CLASSIFICATION OF TYPICAL CHANGES

Type of change	Critical	Major	Minor
Change in systems		
Change in manufacturing formula/process / New Products		
Change in expiry (related to stability)		
Change in critical Raw Material/solvent		
Change in specifications 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 or 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, Data Collection		
Formats and internal labels			
Deletion of a product			

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

Product Change           : Change in key RM/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 formula/process / New Products	Validation of three consecutive batches, with 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 specifications. Updating of SAP. Registration Dossier updation.
Change in test methods	Analytical Method validation, Updating of TDS, Registration Dossier updation.
Change in SOP for addition / deletion of instructions/formats/labels	Training, Change in relevant documents.
Change in expiry	Stability studies, Change in relevant documents, intimation to concerned departments. Registration Dossier updation.
Change/modification    in         equipment/             New equipment	Equipment      qualification.       SOP      preparation, Training, Equipment list updation
Changes 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 changed conditions, Change in relevant documents/labels
Change in primary packaging material	Stability study, Change in relevant documents/BPR, Specification updation.
Change in pack style	Change in relevant documents/BPR, intimation to concerned departments.
Change in printed text	Change in relevant documents/BPR. Intimation to concerned departments.
Change     in     manufacturing     batch     size, manufacturing site/location	Partial validation of three consecutive batches, accelerated/long term stability studies depending on the change.
Change in control systems i.e. computers, configuration of software/firmware, etc.	Validation of the new control system.

Note: This list is not exhaustive and can be extended based on practical changes occurring at the locations.