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.
GMP Support Group
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):
A Deviation
Non Conformance
Un Inten Intentiona tionall “C “Chang hange” e” are also terme termed d as “Incidents”. Through Handling of Deviations
GMP Support Group
What Changes??
Everything what we see today is not constant.
The place,
The cities, The earth,
The universe, all changes with time…
GMP Support Group
Why Control the ‘Change’
Change control is a c GMP Regulatory concept that focuses on managing change to prevent unintended consequence consequences. s.
GMP Support Group
Change Control
A formal system by which qualified representatives from appropriate disciplines (departments) review proposed change.
GMP Support Group
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.
GMP Support Group
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??
GMP Support Group
ecord in a format. 2. R ecord
Record the proposed change in a format. format.
Remember, the format is as per SOP.
The format is approved and current.
Clearly and objectively lay down the proposed change.
GMP Support Group
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.
GMP Support Group
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
Technical Feasibility. GMPs and Quality.
Cost effectiveness.
GMP Support Group
5. Change the corresponding documents.
Identify the necessary documents. Change the documents to implement the change. Circulate the change documents and withdraw the previous documents.
GMP Support Group
6. Impart Training.
Impart adequate training to persons affected / handling the changed system or document.
Record the training.
GMP Support Group
7. Implement the change.
Follow the revised instructions / document and implement the change in system / process.
GMP Support Group
GMP Support Group
8. Evaluate the change.
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.
GMP Support Group
9. Close the Change.
Verify the implementation of change. Verify the change(s) made in corresponding documents.
Verify the implementation document(s).
of
changed
Document all these verifications in Closure form.
GMP Support Group
of Change Illustrations Proposals
Proposed Changes…
Change in the batch Size. Change in Equipment(s) used in Manufacturing Process.
Change in Manufacturing Process. Change in the quantity of Raw Materials / Solvents etc. Change in the Packing Material. Change in system procedure.
GMP Support Group
Proposed Changes…
Change in the batch Size, Requirements:
BPR Process Validation Stability Study
GMP Support Group
Proposed Changes…
Change in Equipment(s) used in Manufacturing Process, Requirements:
Qualified Equipment
BPR
Process Validation [Equipment Specific]
Stability Studies [depends on case-to-case]
GMP Support Group
Proposed Changes…
Change in Manufacturing Process, Requirements:
BPR Process Validation Stability Study
GMP Support Group
Proposed Changes…
Change in the quantity of Raw Materials / Solvents etc. BPR
Process Validation Stability Studies
GMP Support Group
Proposed Changes…
Change in system procedure.
Depends on Case-to-Case,
BPR
Concerned SOP
Validation Valid ation-- Proce Process ss / C Cleani leaning ng / Quali Qualificati fication on
Stability Studies.
GMP Support Group
What Bhaagwat Gita Says..
Change is the Essence of Life.
GMP Support Group
What Bhaagwat Gita do not says..
Document the Change.
GMP Support Group
Presentation by :Dipankar Kaul Quality Assurance Department
[email protected]
