Change management system in the pharmaceutical industry. How to control the changes in the regulatory area.

1. Manojkumar
Change Management System

2. Definition of Change
General Definition of change (Cambridge Dictionary):
 to exchange one thing for another thing, especially of a similar type
 to make or become different:

3. Change Management system as per ICH Q10
 In order to evaluate, approve and implement the changes properly, a
company should have an effective change management system.
 Quality risk management should be utilized to evaluate proposed
changes.
 Proposed changes should be evaluated relative to the marketing
authorization, including design space, where established, and/or current
product and process understanding.
 Proposed changes should be evaluated by expert teams contributing the
appropriate expertise and knowledge from relevant areas to ensure the
change is technically justified
 After implementation, an evaluation of the change should be undertaken
to confirm the change objectives were achieved and that there was no
deleterious impact on product quality.
 Change Management System is applicable throughout the Product

4. Change Management and change Control
 Change Management: A systematic approach to proposing, evaluating,
approving, implementing and reviewing changes (ICH Q10).
 Change control : A formal system by which qualified representatives of
appropriate disciplines review proposed or actual changes that might
affect the validated status of facilities, systems, equipment or processes.
The intent is to determine the need for action to ensure and document that
the system is maintained in a validated state(Annexure 15, EudraLex
Volume 4).
 The scope of change management is much broader than change control,
which was typically applied to one change at a time .
 Change management includes the oversight and management of the
entire portfolio of changes and the change process, including all the
components of change control .
 In a Pharmaceutical Quality System, developed according to ICH Q10,
change management applies across the entire product life cycle.

5. Applications of change Management System (ICH Q10)
Pharmaceutical
Development
Technology
Transfer
Commercial
Manufacturing
Product
Discontinuation
Change is an
inherent
part of the
development
process and
should be
documented; the
formality of the
change
management
process
should be
consistent
with the stage of
pharmaceutical
development.
The change
management
system
should provide
management and
documentation of
adjustments made
to
the process during
technology
transfer
activities
A formal change
management
system
should be in place
for
commercial
manufacturing.
Oversight by the
quality unit should
provide assurance
of
appropriate
science
and risk based
assessments.
Any changes after
product
discontinuation
should go through
an
appropriate
change
management
system

6. Change

7. Purpose of Change control
 The change control shall be used to make approved changes in the
process, method, equipments, materials, procedures, documents and
facilities.
 To create a procedure to ensure that all the changes are properly
identified, specified, reviewed , assessed for risk, approved and
implemented so that changes will not adversely impact on product quality,
safety and efficacy.
 To ensure that the unauthorized changes shall not be made in the
process, method, equipments, materials, procedures, documents and
facilities.
 To ensure that the changes are correctly implemented and are compliant
with the cGMP regulations.

8. Common Errors in Change management / control system
 Not following Change Management / control System properly
 Unable to describe proposed changes accurately
 Unable to document the reason of change
 Failure to perform adequate, in-depth risk assessment
 Unable to take appropriate approvals before implementing a change
 Failure to identified all activities related with the changes such as
documentation, training.
 Lack of awareness in imparting training to all the employees regarding a
change
 The change control process is too bulky and employees use short-cuts to
complete the process.
 The most unauthorized changes are made due to good intension,
employees believed that there is another way to improve the process.

9. Sources of Changes
 Planned and unplanned deviation, preventive actions
 Out of specification investigation findings
 Market or customer complaints
 Internal and External Audits
 Regulatory requirements or findings
 Annual product Quality Reviews
 And many others……..

10. Change Communication

11. Regulatory Requirements
Change control must include the changes to
 Approved documents, Procedures
 Change in source of Raw material / Starting material
 Facility
 Manufacturing Equipments and utilities
 Approved testing methods
 Manufacturing Process

12. Regulatory Requirements
Expectations are that the change control system document
 Description of the change –“from” –“to”
 justification for each change
 Risk/Impact assessment by impacted stakeholders
 Review and approval of impacted departments
 QA involvement/review and Final Approval
 Implementation of proposed changes
 Post-change effectiveness check

13. Change control Procedure (SOP)
Following things must be included in SOP
 Single procedure for all kind of changes
 QA must be single point of co-ordination
 Findings must be documented regarding impact upon: Product quality, safety,
Validation and qualification state, product stability.
 Linkage to other quality systems- validation, QC, training
 Procedure must be user friendly
 Ensure all changes are captured
 Proper Risk assessment of a change ( for categorization into minor and major)
 Provide a procedure for minor and major changes
 Address corrective and preventive actions
 Introduce the concept that all changes must be approved before
implementation
 Procedure for post implementation check (effectiveness check).

14. Training applicable to
 All the users of change control systems and change control forms shall
be trained .
 All the employees i. e. All the temporary employees, All the Permanent
employees and Top Managements should be trained on a basic change
control procedure.

15. Basic Steps of change control procedure
 Initiation of change control form after identification of a change by
Initiating department.
 Description of existing procedure, Proposed change and reason for
change.
 Review and comments on proposed change and reason for change by
initiator department Head.
 Review of Proposed change, reason for change and comments provided
by initiating department.
 Categorization of change into minor and major based on risk assessment
provided by both QA head and user department head.
 Identification of impacted department by QA and impact assessment by
impacted department head.

16. Basic Steps of change Control Procedure
 Review of Impact assessment provided by impacted department by QAD.
 Approval of change for implementation of proposed change by QAD.
 Training to all the users and employees working in GMP area.
 Implementation of proposed changes with appropriate documentation by
Initiating department.
 Closure of change control
 Communication of implemented change to the impacted department as
well as other stakeholders.
 Effectiveness check of implemented change.
 Periodic review of change control

17. Flow chart of Change Control Procedure