Why to Initiate a Change Control Request?

In this article, you will learn why to initiate a change control request.

The statutory and regulatory requirements about the change control management are established by the FDA in the guidance and regulations.

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 as described in ICH Q10.

• 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 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 UNDERSTAND WHY TO INITIATE A CHANGE CONTROL REQUEST 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.

Need help & support during your change control activities or need templates to create a change control procedure, visit us,

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For more details on specific FDA expectations and how to create change control documents necessary, follow us.

Three (3) Options to Create Change Control Request:

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 about Why to Initiate a Change Control Request, refer to:

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