How to Fill a Change Control Form?

How to fill a Change Control Form

 

In this article, you will learn how to fill a change control form as per ICH Q10.

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

  • Change control number:
  • Version
  • Reason and description of the change:
  • Permanent change,
  • Like for like change:
  • Emergency / unplanned change:
  • What change?
  • Why change/justification?
  • How change?
  • Where change?
  • When change?
  • Change type categorization (decision tree
  • Impacted areas of the change
  • Change requirements
  • Change control implementation
  • Request, implementation completion & closure approval.

The following form is an example of the change control request form.

change control form
Change Control Form – Example

 

HOW TO PURCHASE A CHANGE CONTROL FORM AND TEMPLATE PROCEDURE?

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

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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.

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 form necessary, follow us.

Quality procedures templates

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 form?

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 How to fill a Change Control Form?, 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: https://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:

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

https://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

https://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

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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