What Types of Change Controls Exist as per ICH Q10?

In this article, you will learn all different types of change controls that exist as per ICH Q10.

Types of Changes Controls:

Direct to the point, exists 5 types of change control most commonly used and recognized in the pharmaceutical and medical devices industry.

1. Major Change
2. Minor Change
3. Emergency Change
4. Like-for-Like Change
5. Temporary Change

What is a Major change?

Those changes may affect adversely GMP requirements and the critical attributes of a system, facility, apparatus, material, product, procedure, or process.  In addition, these changes may have the potential to cause any type of impairment, damage, or weakening of the product quality or process reliability.

What is a Minor change?

Those changes that unlikely have an adverse impact on the GMP or quality attributes of the product, process, material or procedure on its validated state.  Changes with non-adverse impact on the GMP requirements shall not require a change control.

In addition, to major and minor changes, exists other types of changes such as emergency changes, like of like changes and temporary changes.

What is an Emergency Change?

When an unexpected situation occurs that a change is needed immediately to ensure continued operations. This change must be expedited in the fast track to obtaining its authorization and approval before implementation. Full change control is subsequently filed for evaluation no later than a few business days from execution. Impacted items are withheld from further use pending such evaluation.

What is a Like-for-Like change?

Instruments or parts that perform the same function have the same characteristics and specifications but may be produced by different manufacturers. These may be approved for use as replacement instruments or devices if the validated state is not altered.  Also referred to as a replacement in kind or functionally equivalent instruments or parts.

What is a Temporary Change?

A temporary change is a change approved based on predetermined limits, such as a specific number of units of production (lots) or for a defined period of time. At the end of the specified deadline, the changed process or system must be returned to its normal state. A temporary change may be converted to a permanent change with appropriate approval.

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 Change Control 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.

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REFERENCES:

For more information about Change Control, 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 about Change Control, 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