Change Control

in
Pharmaceutical
Industry
What is Change Control in Pharma?

Change control in pharma is a thorough approach to managing all alterations

that might influence the pharmaceutical product's quality. Change control in
pharma is a critical
Change control in pharmaceutical industry refers to a systematic approach to component of quality
management systems,
manage and document any modifications to established processes, systems, or aiming to mitigate risks
products. associated with
changes while ensuring
compliance with
This ensures the consistent production of high-quality medicinal products, even regulatory standards.
in the face of alterations.
Types of Change Control in Pharma
1. Minor Change
• Low impact on quality, efficacy, safety.
• Often administrative or procedural.
• Requires documentation for transparency.
Through the implementation
of these types of change
2. Major Change
control in pharma, and with
• Moderate to high impact on product characteristics. the guidelines dictating
• Examples: Changing raw material suppliers, adjusting change control
pharmaceutical industry,
formulation.
manufacturers maintain a
• Requires thorough review, validation, and possibly regulatory dynamic yet controlled
communication. environment, ensuring that
every product meets the
highest standards.
3. Critical Change
• Profound impact on drug's quality, safety, efficacy.
• Examples: Overhaul of production process, new tech, significant
ingredient modification.
• Demands exhaustive testing, validation, and regulatory
approval.
1. Identification of Change
The change control process in pharma begins when a change is proposed.

The reasons for change initiation in the pharmaceutical sector can be multifaceted, and identifying the exact nature
and reason for the change is crucial for proper change management in pharmaceutical industry.

Reasons for change can include:

• Equipment/facility upgrades
• Changes in raw materials or suppliers
Identification is not
• Process modifications merely about
• Regulatory requirements recognizing that a
change is necessary, but
understanding the 'why'
During the identification phase of the change control procedure in pharma, it's vital to document: behind it, and gauging
• Reasons for change the potential impact it
may have.
• Potential scope
• Preliminary assessments or observations.
This documentation not only provides clarity for the team involved but also serves as a record for future audits or
reviews.
 2. Justification for Change
The justification step is a pivotal checkpoint in the change control process in pharma.

Just as it's imperative to identify a potential change, it's equally crucial to provide a compelling reason for
implementing it.

Hour 1
1. Purpose & Objective 4. Stakeholder Impact
• Define clear purpose. • Address effects on production teams, quality
• Objectives can include efficiency, safety,  Main Dashboard &regulatory
control, Toolkitsbodies, and consumers.
compliance, product quality, and Overview This phase ensures
addressing challenges.  The Change that changes are
Management
5. Strategic Alignment
well-thought-out,
•
2. Risk vs. Benefit Workflow Ensure fit with organizational goals. beneficial, and in
• Weigh pros and cons.  Starting Projects
6. Evidence/Data
alignment with both
immediate needs
• Consider cost, quality, downtime.  Templates• &UseReports
research, benchmarking, stakeholder and long-term goals.
 Adding Teamfeedback,
Members and other empirical evidence.
3. Resource Assessment
• Evaluate manpower, finances, time,  Customization
7. Regulatory Considerations
expertise, etc.  Importing• & Check
Exporting
compliance implications.
 3. Preliminary Assessment/Review
The preliminary assessment or review serves as the initial screening phase in the change control
pharmaceutical process.

While the earlier steps focused on identification and justification, this phase is centered around
understanding the potential breadth and depth of the change's implications.
Hour 1
1. Immediate Impacts 4. Scope of Change
• Assess direct effects on product quality. • Address effects on production teams, quality
• Ex. Change in raw material affects  Main Dashboard &regulatory
control, Toolkitsbodies, and consumers. This phase acts
formulation. Overview as a filter,
ensuring
 The Change Management
5. Need for Further Analysis
judicious
2. Regulatory Implications •
• Check for regulatory standards or need for Workflow Ensure fit with organizational goals. allocation,
 Starting Projects product quality,
approvals. 6. Stakeholder Involvement and compliance
 Templates• &UseReports
research, benchmarking, stakeholder
3. Potential Risks  Adding Teamfeedback, and other empirical evidence.
• Identify immediate and underlying risks. Members
• Ex. New machine risks: efficiency, safety,  Customization
7. Documentation
contamination.  Importing• & Check
Exporting
compliance implications.
4. Detailed Evaluation
If the change is approved for further consideration, a detailed evaluation is performed.

This step of the change control pharmaceutical process includes:

1. Determining the impact on the product's quality, safety, and efficacy
• Quality: Check stability and potency.
• Safety: Identify risks like contamination. Hour 1
• Efficacy: Ensure therapeutic effect remains. Detailed Evaluation ensures
that any proposed change
 Main
2. Reviewing the effect on current validation Dashboard & Toolkits
status doesn't compromise the
product's safety, efficacy, or
• Does change affect validation? Overview quality, aligns with
• Consider equipment calibrationand The Change
method Management
validation. regulations, and is efficiently
managed in terms of
Workflow resources and time.
 Starting Projects
3. Assessing Potential Regulatory Implications
• Reporting: Any new reports needed?
 Templates & Reports
• Compliance: Ensure alignment  withAdding
regulations.
Team Members
 Customization
4. Evaluating the Necessary Resources & Timeframe
 Importing & Exporting
• Estimate manpower, costs, technical needs.
• Set a realistic timeline.
5. Approval or Rejection
Based on the detailed evaluation, the change may be approved or rejected.

This decision is usually made by a change control board (CCB) or committee comprising: quality assurance,
manufacturing, engineering, regulatory affairs, and other relevant departments.

Here's a brief overview of this phase:

1. Key Decision Factors:

Hour 1
• Safety & Efficacy: Ensure no compromise to product's therapeutic effects.
The approval phase in
• Regulatory Alignment: Ensure  full Main
compliance with industry
Dashboard standards.
& Toolkits pharma change control
• Feasibility: Assess if change is achievable with available resources and
Overview evaluates proposed
without operational disruption. The Change Management changes leading to an
informed decision by the
Workflow Change Control Board.
2. Documentation & Feedback  Starting Projects
• Every decision is documented, including reasons and conditions.
 Templates
• Feedback provided, especially for rejected & Reports
proposals, highlighting areas of
improvement.  Adding Team Members
 Customization
3. Communication:  Importing & Exporting
• Decision shared organization-wide ensuring alignment across departments.
6. Communication
Throughout the process, effective communication is essential in change control pharmaceutical process.

Stakeholders, including those in production, quality control, and regulatory affairs, must be informed of the change and
its implications.

1. Broad Awareness
Hour
• Unified understanding across departments: R&D 1
to manufacturing.

2. Feedback Mechanism  Main Dashboard & Toolkits

• Channels for teams to voice insights and concerns. By ensuring clear
Overview communication,
 The Change Management you can smoothly
3. Stakeholder Engagement navigate changes,
Workflow
• Inform key parties like suppliers if their roles are affected. minimizing errors
 Starting Projects and maintaining

4. Regulatory Notification  Templates & Reports product integrity.

• Communicate major changes toauthorities

Adding Team Members
for compliance.
 Customization
5. Documentation  Importing & Exporting
• Record communications for transparency and audits.
7. Implementation
When a change is approved, the implementation phase of the change control pharmaceutical process comes into play.

Properly executing this stage is crucial for ensuring the integrity of the change and maintaining the standards that the
pharmaceutical industry demands.

In the pharmaceutical realm, the implementation of any approved change must adhere to strict protocols:
Hour 1
1. Detailed Plan
• Strategize using the change control SOP. Dashboard & Toolkits
 Main The precise
implementation of
• Incorporate re-validation if required.
Overview changes, guided by
established change
 The Change Management
2. Document Updates control SOP, upholds
Workflow
• Revise affected SOPs, batch records. the stringent
standards of the
 Starting Projects
• Utilize SOP templates for consistency. pharmaceutical
 Templates & Reports sector.
3. Execution  Adding Team Members
• Critical step guided by SOP.  Customization
 Importing & Exporting
8. Verification
After the change has been implemented, it's crucial to verify that it was executed correctly and that there are no
unintended consequences.

This step of the change control pharmaceutical procedure might involve:

1. Testing
Hour
Specific tests, possibly both qualitative and quantitative, are 1
carried out to confirm
that the change meets its intended objectives and that no detrimental effects on Through these
product quality or process efficiency have verification activities,
 occurred.
Main Dashboard & Toolkits the pharmaceutical
Overview entity ensures that the
2. Inspections  The Change Management change not only meets
its intended purpose but
Physical inspections may be necessary, especially when the change involves
Workflow also maintains the
equipment, facilities, or tangible materials. This helps in ensuring that installations or
 Starting integrity of the product
Projects and process.
modifications adhere to standards and  specifications.
Templates & Reports
 Adding Team Members
3. Audits
 Customization
An audit, which can be internal or external, reviews the&documentation,
 Importing Exporting processes,
and outcomes related to the change. It ensures that the implementation aligns with
the change control SOP, regulatory requirements, and industry best practices.
9. Closure and Review
The final step in the change control process is to formally conclude the initiative and reflect upon its long-term
implications:
1. Formal Closure
After ensuring the change has been successfully implemented, verified, and all necessary
documentation is in place, the change control request can be formally closed in the system or
registry. Hour 1
Through these
2. Post-implementation Review verification activities,
 Main Dashboard & Toolkits the pharmaceutical
Even after the change is finalized, periodic assessments are vital. These reviews monitor the
Overview
change's sustained effectiveness, ensuring it continues to meet the desired objectives without
entity ensures that the
change not only meets
introducing unforeseen issues.  The Change Management its intended purpose but
Workflow also maintains the
3. Feedback Collection  Starting Projects integrity of the product
and process.
Gathering feedback from various departments  and
Templates & Reports
stakeholders provides insights into the
change's real-world impact, offering valuable lessons for future change control initiatives.
Adding Team Members
a

 Customization
4. Continuous Improvement
 Importing & Exporting
The insights from these reviews feed into a cycle of continuous improvement, enabling better
handling of subsequent changes and refining the change control process itself.
 AGS
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