Change Management

A Systematic Procedure for

Handling 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):
‰ To Diversify
‰ To Improve

„ Un Intentionally (Un
Planned):
‰ A Deviation
‰ Non Conformance

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Handling of Change…

„Un Intentionally (Un-Planned):

‰A Deviation
‰Non Conformance

Un Intentional “Change” are also termed 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,
‰ 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 consequences.

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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 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.

„ Identify the potential change. Identify its :

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

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 2. Record in a format.

„ Record the proposed change in a format.

‰ Remember, the format is as per SOP.
‰ The format is approved and current.
‰ 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

‰ Technical Feasibility.

‰ GMPs and Quality.

‰ Cost effectiveness.

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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.

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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.

„ The person(s) involved in the ‘changed

process’ to study the impact of change into
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.
„ Verify the implementation of changed
document(s).
„ Document all these verifications in Closure
form.

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Illustrations of Change
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.

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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
‰ BPR
‰ Process Validation [Equipment Specific]
‰ 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
„ Validation- Process / Cleaning / Qualification
„ 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
dipankarkl@drreddys.com