All you need to know about Change Control Management

In this article, you will learn about Change Control Management as per ICH Q10?

Change control management is the system used to ensure that any modifications to validated equipment, materials, components, or processes are introduced in a controlled and coordinated manner. The change control management applies across the entire product lifecycle. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users.

A change is defined as a planned and lasting change of a product or a process characteristic which may affect the safety, the quality, or the performance of an item:

Change control management is the methodology, procedures, and instructions that establish how to handle and manage all changes made to a product or system in the cGMP process.

Indeed, change control within quality management systems (QMS) is a process used to confirm that changes to a product or system are introduced in a controlled and coordinated manner.

It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users.

The objective of a change control management aims to reduce any potential disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change.

The change control process is performed following a sequence of 6 simple steps starting with the submission of a change request.

This article describes how to make a change control in 6 steps:

1. Documenting the change request:
2. Formal assessment:
3. Planning:
4. Designing and testing:
5. Implementation and review:
6. Final assessment:

Types of Changes

• Major change
• Minor change
• Emergency Change
• Like-for-Like change
• Temporary Change

What is a Change Control Management Procedure?

The change control procedure is intended to minimize the disruption of services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change.

The change control form is a document that collects all information about the change or modification, explaining any modification necessary, and request authorization prior implements it.  It is a notification document to all parties involved in a particular change that may impact several validated areas, products, or processes.

Change control is necessary whenever a change is introduced to the established GMP procedures, batch record instructions, specifications, equipment settings, validated process, material, or product.

More specifically, a change request is recommended if the proposed internal change adds, modify, or remove the process or its validated state.

Why to initiate a change control effort?

• Reason number 1 is because the GMP and the QSR mandate to establish a change control management system.
• The reason number 2 is because a change control document approved by the management before been implemented is a “Liability Insurance” for the employees and persons working in such implementation initiative in case the results are not favorable, some unexpected problem is found or an inconvenient arise after implementing the change.
• The reason number 3 is because it serves as a historic logbook of all changes in the chronologic order to evaluate, investigate, correlate and document how were the parameters and conditions previously. It may support the preventive maintenance schedules and actions based on the historical behavior of some processes and systems during its life cycle.

Consequences to not initiate or not perform an adequate Change Control on-time?

Failure to adhere to proper Change Control handling is considered a violation of US Federal regulations on good manufacturing practices. As a consequence, medicine or medical device can be termed as adulterated or substandard if the company has failed to implement, record, and analyze the outcome of a change, and failed to design and implement an effective change control.  In some cases, it may result in an FDA warning observation, product hold, product recall, etc.

How to Fill a Change Control Form?

The change control may include, but, is not limited to complete the sections and information, (as applicable)

HOW TO PURCHASE A CHANGE CONTROL FORM AND TEMPLATE PROCEDURE?

A change control form and procedure template are available from the CIQA Store.

CONTACT US IF NEED HELP TO MAKE OR REVIEW YOUR CHANGE CONTROL DOCUMENT(S)?

Need Training

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Change Control or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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Three (3) Options to Create Change Control Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Change Control Management procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on how to prepare a change control?

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

For more information, refer to:

STATUTORY AND REGULATORY REQUIREMENTS

The Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations describes the importance of this topic in the following reference: httpss://www.fda.gov/media/71023/download

It is a systematic approach to proposing, evaluating, approving, implementing, and reviewing changes (ICH Q10)

For more information, refer to:

httpss://www.fda.gov/media/118202/download

httpss://www.fda.gov/media/85273/download

QS Regulation and Guidance • Quality System Regulation and Preamble

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Inspection Guide – Pages 8, 15, 21, 22 and 23

httpss://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm