Change Management

 

Change Management

 A Sy Sys s t em emat atii c Pro Pr o c ed edu u r e ffo or Hand ndli ling ng Changes.

 

 What is ‘Change’?? 

 A departure from set procedures /systems, (documents, equipments, packaging, utilities, process, testing….) either   

intentional or un-intentional.

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 Why Change?? 

Intentionally (Planned): (Planned):  



To Diversify To Improve

Un Int Inte enti nt i ona on all lly y (U (Un Planned):: Planned)  

 A Deviation Non Conformance GMP Support Group

 

Handling of Change… Un In In tenti tent i o n al l y (U (Un -Pl an ned): ned):

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 A Deviation

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Non Conformance

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Un Inten Intentiona tionall “C “Chang hange” e” are also terme termed d as “Incidents”. Through Handling of Deviations

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 What Changes?? 

Everything what we see today is not constant. 

The place,



The cities, The earth,

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The universe, all changes with time…



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 Why Control the ‘Change’ 

Change control is a c GMP Regulatory concept that focuses on managing change to prevent unintended consequence consequences. s.

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Change Control 

 A formal system by which qualified representatives from appropriate disciplines (departments) review proposed change.

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Handling the changes 

Identify the potential change.

Record the proposed change in a format.  Give reasoning with complete scientific rationalization for proposed change.   Approve from competent competent person(s).  Change the necessary documents. 

  

Train the persons. Implement the change. Evaluate the change.

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Handling Changes From Control to Management, …A 9 Steps Journey.

 

1. Identify the potential change. 

Identi Ide ntify fy the pote potenti ntial al change change.. Iden Identif tify y its : 



Requirement , is it required as a statutory obligation. Significance , will it improve the quality, process or reduce cost??

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ecord in a format. 2. R ecord 

Record the proposed change in a format. format. 

Remember, the format is as per SOP.

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The format is approved and current.

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Clearly and objectively lay down the proposed change.

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3. Give reasoning and scientific rationalization. 

In the format itself, lay down: 

The scientific rational to support the views for proposed change. Give evidence from past records  

 Alternatively give current technical data for support.

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4. Approve from competent person(s). 

Circulate the proposal of change to the concerned persons



for evaluation. The proposed change is evaluated with respect to: 

Regulatory Submissions

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Technical Feasibility. GMPs and Quality.

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Cost effectiveness.

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5. Change the corresponding documents.  

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Identify the necessary documents. Change the documents to implement the change. Circulate the change documents and withdraw the previous documents.

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6. Impart Training. 

Impart adequate training to persons affected / handling the changed system or document. 

Record the training.

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7. Implement the change. 

Follow the revised instructions / document and implement the change in system / process.

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8. Evaluate the change. 

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The person(s) involved in the ‘changed proces pro cess’ s’ to study study the the impac impactt of chang change e int into o product and process or system. QA to monitor the impact of changed process for safety, identity, strength, purity and quality of the product.

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9. Close the Change.  

Verify the implementation of change. Verify the change(s) made in corresponding documents.

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Verify the implementation document(s).

of

changed

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Document all these verifications in Closure form.

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of Change Illustrations Proposals

 

Proposed Changes…  

Change in the batch Size. Change in Equipment(s) used in Manufacturing Process.

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 

Change in Manufacturing Process. Change in the quantity of Raw Materials / Solvents etc. Change in the Packing Material. Change in system procedure.

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Proposed Changes… 

Change in the batch Size, Requirements:  



BPR Process Validation Stability Study

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Proposed Changes… 

Change in Equipment(s) used in Manufacturing Process, Requirements: 

Qualified Equipment

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BPR

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Process Validation [Equipment Specific]

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Stability Studies [depends on case-to-case]

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Proposed Changes… 

Change in Manufacturing Process, Requirements:  



BPR Process Validation Stability Study

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Proposed Changes… 

Change in the quantity of Raw Materials / Solvents etc.  BPR  

Process Validation Stability Studies

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Proposed Changes… 

Change in system procedure. 

Depends on Case-to-Case, 

BPR



Concerned SOP

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Validation Valid ation-- Proce Process ss / C Cleani leaning ng / Quali Qualificati fication on

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Stability Studies.

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 What Bhaagwat Gita Says.. 

Change is the Essence of Life.

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 What Bhaagwat Gita do not says.. 

Document the Change.

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Presentation by :Dipankar Kaul Quality Assurance Department [email protected]