Good Distribution Practices Toolkit Change Control

10 March 2016

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Disclaimer

• The content of this presentation were derived mainly from WHO training material on Change Control and edited to suit the Distributor Operations.

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Definitions • Any proposed change that requires an evaluation to determine the

impact of any of the following: - Regulatory Filing - Validated state of device design, GMP system, facilities, equipment or of

validated methods - Product quality attributes or critical parameters/functionality

• Change Record: A system through which the effects or risks of changes initiated in the GMP environment are controlled to a predictable level.

• Roles and Responsibilities should be documented with all appropriate stakeholders involved in initial assessment and throughout change record lifecycle.

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Definition

• In the WHO-GMP guideline glossary there is definition of the term “change control”

• However, the GMP guideline basically contains only few notes about the handling of changes

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Why Controlling the Change?

• 14.3 Procedures should be established and maintained for the preparation, review, approval, use of and control of changes to all documents relating to the distribution process. Procedures must be in place for both internally generated documents and those from external sources.

WHO-GMP

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Change Control Ensures That… Properly assessed by all applicable functional or site

experts (including Regulatory Affairs), and approved by QA Contacts before implementation

Implemented according to approved plans

Properly documented

Assessed after implementation to ensure that changes are in control

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Principles of change control • Each change to previously approved requirements

requires a review and authorization to keep the system in its original state of “proven suitability”

• Formal change control guarantees that all changes are evaluated for their effect on product quality or validation status

• Change control minimizes the risk that changes can have on the quality or process characteristics

• Change control programs have become recognized as essential element of the pharmaceutical quality assurance system

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Change control programs

• Change control helps to maintain the validated and established status. Validated processes and qualified facilities can be influenced by changes and products no longer comply with specifications

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Scope of change control

• Change control is not department-specific, rather the task of the whole company

• The change control monitors all types of changes which can influence the process or product quality and states the measures necessary for implementing the change or decides that a change should not be implemented

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Change control Team

• An important function as part of the change control program is fulfilled by the “change control Team (change control board)

• The task of this team is to evaluate the changes, establish and coordinate measures to put in place and authorize the changes

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Typical Stakeholders • Change Owner • Quality • Regulatory • Engineering / Calibration • Validation • Partner Client • Subject Matter Experts (SMEs) • Information Systems (IS)

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Change Control SOP

• Change control requires a written procedure • First point for Audit • Covers the overall approach • Roles must be clearly documented • Ensure cross-functional evaluation of the

proposed change

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Change Record lifecycle • Initiation • Impact assessment • Define pre-implementation and post

implementation tasks • Owner and QA approval of tasks • Completion of pre-implementation • Approval to implementation • Completion of post implementation tasks • Closure of change record

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Process

• Changes requiring control are generally documented in the form of a “change request” in which the applicant for the change proposes the type of change, suggests the timeframes and measures for carrying out the change

• The change control team authorizes or not the change

• The documentation for the change procedure should show that the change was evaluated (risk analysis)

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Documentation • Change control procedure includes flow chart

of the change control process and the change request form (or change form)

• Change request form records a request for change so that each change is documented before it is approved

• The change request form includes the description of the change, the benefits, costs, urgency of the change, change impact

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Change control procedure: flow chart (example 1)

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Change control procedure: flow chart (example 2)

Change Request Submission

Evaluation of Change Impact

Validation Change Request

More information required

Change Activities

Change Closed

Approval

Activities Completion

Change Activities

Approval

Activities Completion

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Change control procedure: flow chart (example 3)

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• Change control procedure: flow chart (example 4)

CCB = change control board

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• Change control procedure: flow chart for change master documents (example 1)

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• Change request form (example 1, 1/2)

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• Change request form (example 1, 2/2)

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• Change request form (example 2, 1/2)

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• Change request form (example 2, 2/2)

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• Change request form (example 3)

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Sample change record form

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Sample change record form

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Documentation

• All quality-relevant changes should be documented

• All actions to be taken, including the need for and extent of qualification or validation, should be described

• The records can be archived in paper form or electronically

• When storing documents, raw data and other relevant documents for change should be kept accessible

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Documentation

Change control logbook (year:________)

Closing date

Actions and time limit

Approval date

Description Item Requester /

department

Request date

Nb.

Change control logbook Page:__ of ____

QA Manager signature _________ Date_______

Auditing Change Control

• Change Control standard operating procedure • Check that all relevant steps for change

control implementation are detailed • Choose some applications (from the list in the

logbook) • Verify the applications and all requested

documents (change request form, investigation, request and closing date)

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Questions and Answers

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