Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
What is Change Control in Good Distribution Practice (GDP?
Change Control in GDP (Good Distribution Practice): What You Need to Know.
If you are involved in the distribution of medicinal products, you may have heard of the term “change control”. But what does it mean and why is it important for ensuring the quality and safety of the products you handle?
Change control in GDP is a formal process used to manage any changes that may affect the compliance with Good Distribution Practice (GDP). GDP is a set of guidelines that ensure that medicinal products are stored, transported and handled under suitable conditions, as required by the marketing authorisation or product specification.
Where can a Change Control in GDP happen?
Changes can occur at any stage of the distribution chain, such as:
- Changes in the product specifications, packaging, labelling or shelf-life.
- Changes in the suppliers, customers, contractors or service providers.
- Changes in the premises, equipment, vehicles or storage conditions.
- Changes in the procedures, processes, systems or documentation.
- Changes in the legislation, regulations or standards.
Some changes may have a significant impact on the quality and integrity of the products, while others may have a minor or no impact. Therefore, it is essential to identify, document and assess the changes before implementing them, to ensure that they do not compromise the compliance with GDP.
What does a Change Control in GDP do?
The purpose of change control is to:
- Evaluate the need and justification for the change.
- Identify the potential risks and benefits of the change.
- Define the scope and responsibilities for the change.
- Plan and execute the change in a controlled and coordinated manner.
- Verify and validate the effectiveness of the change.
- Communicate and document the change and its outcomes.
- Monitor and review the change and its impact.
Change control in GDP and the QMS
Change control in GDP is part of a quality management system (QMS), which is a set of policies, procedures and processes that ensure that an organisation meets its quality objectives and customer expectations.
A QMS should be established and maintained by every wholesaler and manufacturer of medicinal products, as required by GDP.
A QMS should include a written procedure for change control, which describes how changes are initiated, approved, implemented, and documented.
The procedure should also define the roles and responsibilities of the personnel involved in the change control process, such as:
- The initiator: the person who proposes or requests the change.
- The approver: the person who authorises or rejects the change.
- The implementer: the person who carries out or oversees the change.
- The verifier: the person who checks or tests the change.
- The reviewer: the person who evaluates or audits the change.
The procedure should also specify how changes are classified according to their impact and urgency, such as:
- Major: a change that has a significant impact on the quality or safety of the products or on the compliance with GDP.
- Minor: a change that has a minor or no impact on the quality or safety of the products or on the compliance with GDP.
- Urgent: a change that needs to be implemented immediately due to an emergency or a critical situation.
- Routine: a change that is part of a regular or planned activity.
Documenting the Change Control
The procedure should also indicate how changes are documented and recorded, such as:
- Change request form: A document that describes the details of the proposed change, such as its rationale, scope, risks, benefits, implementation plan and approval status.
- Change log: A document that records all changes that have been initiated, approved, implemented and verified.
- Change report: A document that summarises the outcomes and results of the change, such as its effectiveness, impact and lessons learned.
Summary
Change control in GDP is an essential element of compliance, as it ensures that any changes that may affect the distribution of medicinal products are managed in a systematic and transparent way. By following a robust change control process, you can prevent errors, deviations, complaints and recalls, and maintain the quality and safety of your products.
Further Assistance
Overlooking and not engaging Change Control in GDP when it is required can have serious ramifications. Inspectors will need to be satisfied that you know what to do.
If you or your staff have any uncertainty about how to engage and manage a Change Control, Paradigm Shift Consulting Ltd have a broad range of courses available online to help you. If you have a specific query or a situation in your business that needs addressing, you can call us on 0330 133 0920 or email us on info@gdptraining.co.uk.
Alternatively, you can use the contact form at the foot of this page.
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