What 4 Status of the cGMP Documents Exists?

What 4 Status of cGMP documents exists

 

In this article, you will learn the 4 Status of the cGMP documents based on ALCOA.

Each company defines and establish their own document states that the document control management must handle for each document or piece of evidence.  Examples of the most common document status are:

  1. Draft Document -Unapproved,
  2. Original Document – Approved,
  3. Copy or Duplicated Document – Approved,
  4. Obsolete Document.

The status of the cGMP documents determines the access and data integrity controls necessary.

Based on the status of each GMP document, different management controls may apply to them.

These controls include version control, unique numbering control, and copy control of forms and documents based on their status.

The following table show how some companies define the controls for each document based on their status:

 

Document Controls Document Status
Draft Document

(Unapproved)

Original Document (Approved) Copy or Duplicated Document (Approved) Obsoleted Document
Must contain a unique number? No Yes Yes Yes
Must be approved by a qualified representative(s)? No Yes Yes Yes
Copies must have a unique number (serial number on duplicated documents)? No n/a Yes No
Storage Control? No Yes Yes Yes
Version control, history, and audit trail of any change? No Yes Yes n/a

 

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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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REFERENCES:

For more information about the Status of the cGMP documents, 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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