IP Related Docs

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    • #2763
      Brad Russell
      Participant

      Hi all – Looking for advice on filing location of IP Documents. The info that I could find tends to be a bit vague when it comes to zone 06; I’ve consulted some IP experts at my company, but they had a difficult time mapping to the Reference Model. If any one could provide suggested artifacts for the below (or other helpful docs), I’d greatly appreciate it:

      Production Records
      – Lot Combination Packaging Summary
      Batch Records
      – Batch records, production orders, etc.
      Packaging Specifications
      IP Specifications
      – MSDS, Testing, etc.

    • #2764
      Kathie Clark
      Participant

      Hi Brad,

      I would appreciate the opinion of others, but I think that many of the document types you mention aren’t literally part of the TMF. For example, if you consult MHRA GCP, p. 333, there is a diagram that shows IMP documentation as part of “Supporting documentation” and not part of the TMF.

      That doesn’t mean it’s not inspectable, but that the expectation would not be that it is filed in a TMF structure.

      I also see the following in an MHRA presentation on GCP.
      •Essential documents (E6 section 8) can reside on a single system, but the MHRA extended expectations include access to material residing on different systems:
      –GMP data (e.g. batch records) not needed by clinical staff
      –Regulatory documentation (e.g. applications to MHRA)

      Would be interesting to hear from those with inspection experience on this point.

      Kathie

    • #2765
      Eldin Rammell
      Participant

      I agree with Kathie in that these types of records are not usually managed within a TMF system. They can be requested during inspections – and the MHRA have explicitly stated that GMP batch records are part of the TMF – but are typically managed as part of GMP-regulated manufacturing records.

      This is not a recommendation, but if you chose to file in the main TMF and therefore wanted to align them with an existing artifact rather than creating a new one, I suggest 06.02.03 might be the most appropriate….. based on the purpose/description of the artifact rather than the artifact name:
      “Any certificate, license OR OTHER DOCUMENTATION that is required by a specific regulation to verify the quality, source, MANUFACTURE, ingredients or other aspect of investigational and/or control product.”

      You could perhaps define sub-artifacts for production records / batch records under 06.02.03., though I would still prefer to see them managed outside the TMF system as GMP records.

      Kind regards,
      Eldin.

    • #2766
      Karen Williams
      Participant

      Most IP documentation are site related documents related to the study trial. The documents you are speaking about or mainly kept in lab manuals. Unless specified by the sponsor to file in the central file section.

      Below are the area we file site submitted IP documents:
      06.01.02 IP Instructions for Handling IP Instructions for Handling 06.01.02 IP Instructions for Handling
      06.01.03 IP Sample Label IP Sample Label 06.01.03 IP Sample Label
      06.01.04 IP Shipment Documentation “IP Shipment Pro Forma Invoice
      Packaging Order
      Shipment Request Form
      Approval to Ship
      Acknowledgement of Receipt
      IP Shipment Documentation: Other” 06.01.04 IP Shipment Documentation
      06.01.05 IP Accountability Documentation IP Accountability Documentation 06.01.05 IP Accountability Documentation
      06.01.06 IP Transfer Documentation IP Transfer Documentation 06.01.06 IP Transfer Documentation
      06.01.07 IP Re-labeling Documentation IP Re-labeling Documentation 06.01.07 IP Re-labeling Documentation
      06.01.08 IP Recall Documentation IP Recall Documentation 06.01.08 IP Recall Documentation
      06.01.09 IP Quality Complaint Form IP Quality Complaint Form 06.01.09 IP Quality Complaint Form
      06.01.10 IP Return Documentation IP Return Documentation 06.01.10 IP Return Documentation
      06.01.11 IP Certificate of Destruction 06.01.11 IP Certificate of Destruction
      06.01.12 IP Retest and Expiry Documentation IP Retest and Expiry Documentation 06.01.12 IP Retest and Expiry Documentation
      06.02.01 QP (Qualified Person) Certification QP (Qualified Person) Certification 06.02.01 QP (Qualified Person) Certification
      06.02.02 IP Regulatory Release Documentation IP Regulatory Release Documentation 06.02.02 IP Regulatory Release Documentation
      06.02.03 IP Verification Statements IP Verification Statements 06.02.03 IP Verification Statements
      06.02.04 Certificate of Analysis Certificate of Analysis 06.02.04 Certificate of Analysis
      06.03.02 IP Unblinding Plan IP Unblinding Plan 06.03.02 IP Unblinding Plan
      06.04.01 IP Storage Condition Documentation IP Storage Condition Documentation 06.04.01 IP Storage Condition Documentation
      06.04.02 IP Storage Condition Excursion Documentation IP Storage Condition Excursion Documentation 06.04.02 IP Storage Condition Excursion Documentation
      06.04.03 Maintenance Logs (Device) Maintenance Logs (Device) 06.04.03 Maintenance Logs (Device)
      06.05.01 Non-IP Supply Plan Non-IP Supply Plan 06.05.01 Non-IP Supply Plan
      06.05.02 Non-IP Shipment Documentation Non-IP Shipment Documentation 06.05.02 Non-IP Shipment Documentation
      06.05.03 Non-IP Return Documentation Non-IP Return Documentation 06.05.03 Non-IP Return Documentation
      06.06.01 IRT User Requirement Specification IRT User Requirement Specification 06.06.01 IRT User Requirement Specification
      06.06.02 IRT Validation Certification IRT Validation Certification 06.06.02 IRT Validation Certification
      06.06.03 IRT User Acceptance Testing (UAT) Certification IRT User Acceptance Testing (UAT) Certification 06.06.03 IRT User Acceptance Testing (UAT) Certification
      06.06.04 IRT User Manual IRT User Manual 06.06.04 IRT User Manual
      06.06.05 IRT User Account Management IRT User Account Management 06.06.05 IRT User Account Management
      06.07.01 Relevant Communications IP and Trial Supplies Relevant Communications 06.07.01 Relevant Communications
      06.07.02 Tracking Information IP and Trial Supplies Tracking Information 06.07.02 Tracking Information
      06.07.03 Meeting Material “IP and Trial Supplies Agenda
      IP and Trial Supplies Minutes
      IP and Trial Supplies Presentation Materials
      IP and Trial Supplies Questions and Answers
      IP and Trial Supplies Meeting Material: Other”
      06.07.03 Meeting Material
      06.07.04 Filenote IP and Trial Supplies Filenote 06.07.04 Filenote

    • #2778
      Brad Russell
      Participant

      Thanks all for your responses.

      @Kathy & @Eldin – Both of you state that there is not an expectation that these are included within the eTMF, but that they are inspectable – would then a regulatory body such as MHRA or EMA expect direct access to the system in which these documents are stored? – Furthermore would they expect that this system meets certain requirements (would an environment such as a restricted area SharePoint or Box environment be acceptable?)

    • #2779
      Kathie Clark
      Participant

      Brad, I can’t lay my hands on anything in writing at this time pertaining to IP specifically, but Andy Fisher’s very detailed 2015 presentation mentions guided access to similar systems as being acceptable. I do not think that the HAs would want to have to train on more than a few systems (preferably one) and it’s my recollection that MHRA mentioned that systems storing data could be accessed with an expert to assist. Maybe someone else who attended MHRA’s TMF day a few years ago would have something in writing.

      Pertaining to the requirements on storage, EMA says:

      “The TMF should be managed securely at all times to ensure completeness and to prevent accidental or premature loss, unauthorised alteration or destruction of documents. Access to the TMF should be based on a role and permission description that is defined by the sponsor and/or investigator/institution.”

      So the system of record (whether part of the core TMF or not) should be subject to these controls and should also be subject to validation/UAT. If you are transferring records electronically, that transfer should also be controlled/validated. If this is really the system of record for batch records or MSDS, one would expect that anyway.

      • This reply was modified 10 months, 3 weeks ago by Kathie Clark.
    • #2785
      Eldin Rammell
      Participant

      Kathie nailed it!

      The EMA TMF guidance document provide quite comprehensive requirements regarding electronic filing systems used for TMF content and those requirements apply to the primary eTMF and to supporting systems that also hold TMF content.

      In any event, if IP-related records are held outside the eTMF, they would be subject to GMP requirements for computerized systems…. which mirror those for GCP since inspectors use a common GxP document for computerized systems.

    • #2786
      Rebecca Halbur
      Participant

      Hi Brad,
      We recently had an MHRA inspection with Andy Fisher as our lead inspector. We have approximately nine systems in which various documentation is housed that would be considered inspectable but not filed in our core eTMF system. We prepared access for all of these systems (in line with E6), but Andy and his team ended up only wanted direct access to our core system and guided access to the others.
      We are still maintaining the option for direct access in the future as another inspector may have a different preference, but in my most recent experience, I can say that we ended up doing guided access for these disparate systems as needed.

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