When is necessary Document Control Management DCM?

when is necessary a Document Control Management

 

In this article, you will learn when is necessary a Document Control Management?

Documentation control management needs it whenever a change is introduced to the established GMP procedures, batch record instructions, specifications, equipment settings, validated process, material, product, etc.

More specifically, a GMP document must be controlled if it adds, modifies, or impact any of the following areas:

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

Consequences to not initiate or not perform an adequate Document Control on-time?

Failure to adhere to proper Document 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 document control.  In some cases, it may result in an FDA warning observation, product hold, product recall, etc.

STATUTORY AND REGULATORY REQUIREMENTS

Title 21 CFR Part 11 that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES), as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a))

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

https://www.fda.gov/media/75414/download

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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 Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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Quality procedures templates

Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM 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 when is necessary a Document Control Management.

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.

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REFERENCES:

For more information about when is necessary a Document Control Management, refer to:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40

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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