What is Change as per ICH Q10?

In this article, you will learn what is change, according to ICH Q10 for the pharmaceutical and medical device industry?

What is Change?

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:

Product-related changes, as apply:

• Raw materials and components.
• Labeling, packaging.
• Product specifications.
• Sterilization, GAMMA, ETO, etc.
• Customer-related documents (drawings, instructions For Use, validation guides, certificate of release).
• Suppliers, vendor changes, and qualification modifications.

Process related changes:

• Supplier processes and locations
• Manufacturing processes.
• Packaging processes.
• Incoming processes.
• Inspection processes.
• Shipping and distribution processes.
• Equipment (installations of new equipment, devices, supply systems, lab and production, computerized systems)
• Hardware and Software, firmware, configurations
• Procedures (manufacturing, in-process, QC, and release)
• Facilities and utilities (manufacturing and warehouse locations, storage conditions)

What is Change Control Management?

Learn How to Perform a Change Control in 6 Steps?

HOW TO PURCHASE A CHANGE CONTROL FORM AND TEMPLATE PROCEDURE?

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

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 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:

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)

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