When is Necessary a Change Control Request?

In this article, you will learn when is necessary a Change Control Request.

A change control request is needed 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 control request is recommended if the proposed internal change adds, modify, or remove any of the following:

• Specification criteria for raw materials, internally/externally manufactured components, or internally/externally finished products
• Packaging or labeling information, processes, or materials.
• The shelf life of raw material, components, or finished products
• Process parameters
• Tools or consumables (i.e. wipes, gloves, shoe covers, etc.)
• Equipment or equipment settings
• Qualified cleanrooms
• Cleaning processes of the manufacturing environment or manufacturing equipment
• Facilities or utilities
• Locations for manufacturing, testing, sterilization, or warehousing
• Environmental conditions of manufacturing, testing, or storage,
• Control of monitoring processes for the manufacturing, testing, storage, or distribution environment
• Suppliers or external manufacturers
• Line re-configuration as it relates to operators changing from a seated to standing position, updates to line and station layouts or re-sequencing of process steps
• Throughput time as it relates to changes to the material storage time between processes
• Product handling techniques as it relates to material storage and conveyance
• Working with multiple lots at different stations
• Layouts in areas of product handling like manufacturing and warehouse
• Any change that can potentially impact form, fit or function and the quality of the product.
• Changes related to supplied items, raw material, components, or finished products in regards to:
  • manufacturing or assembly processes
  • control or monitoring processes
  • cleaning processes
  • product handling
  • inspection or release processes
  • configuration check inspections
  • sample size or sampling plans
  • method of testing (e.g. physical, analytical, microbiological)
  • packaging or labeling processes
  • sterilization process
  • storage, shipment, or distribution processes

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 DETERMINE WHEN IS NECESSARY A CHANGE CONTROL REQUEST.

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,

SUBSCRIBE AND FOLLOW US TO LEARN MORE.

For more details on specific FDA expectations and when is necessary a change control request, 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 to determine when is necessary a change control request

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.

GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)

REFERENCES:

For more information about when is necessary a Change Control Request, 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 when is necessary a Change Control Request, 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