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Packaging of Clinical Supplies Logistics and Practical Aspects of Packaging

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Title: Packaging of Clinical Supplies Logistics and Practical Aspects of Packaging


1
Packaging of Clinical Supplies Logistics and
Practical Aspects of Packaging Labeling CTMs
  • Michael S. McNear R.Ph.
  • Fisher Clinical Services
  • Allentown, PA

2
Outline
  • Planning…Planning…Planning
  • Labeling Concepts
  • Packaging Concepts
  • Summary

3
Where It All Starts
  • Clinical Trial Material Professionals must be
    involved in the protocol planning and conception
    stages
  • This does not mean medical fills out a form and
    sends it to you….
  • It involves active participation in all aspects
    of the study planning process from the earliest
    possible time point.

4
Basic Facts
  • Bulk chemical or drug supply availability and
    timelines
  • Dosage forms available
  • Protocol scope (where?)
  • Available stability information
  • Study Start Date

5
Study Start Date
  • Is it negotiable?
  • Initially no…..
  • As time goes on…..maybe
  • Clinical Supply Professionals must be informed
    and involved. Study initiation is complicated
    for all aspects of the process and the start date
    is likely to move….how effective is your CSM
    organization at knowing the real date??

6
Early Decisions Program Level
  • Comparator choice/strength and blinding
    considerations
  • Need for new analytical methods
  • Need for new stability data
  • Start multiple programs….what is not needed can
    always be cancelled
  • Visit Schedule(s)
  • Critical to package concept design

7
Early Decisions
  • Proposed dosing information
  • Any manufacturing/packaging considerations
  • Humidity control
  • Light Sensitivity
  • Logistics
  • Temperature control
  • Hazardous transport

8
Early Risk Assessment
  • Failure to begin research about the comparator,
    blinding, analytical and stability information at
    the protocol inception phase is one of the
    greatest risks to study delay.
  • Research multiple comparators
  • Risk is minimal…build in milestones for actual
    large expenditures

9
Early Risk Assessment
  • Logistics - Especially the participating country
    list.
  • Language consideration
  • Import/export considerations
  • EU release issues
  • Comparator sourcing
  • Transport considerations
  • Start with a list of all possible countries with
    a commitment to update regularly

10
Moving Forward… Considerations and decisions
that must be made BEFORE protocol finalization
  • To IVR or not IVR
  • IVR can be an effective tool for nearly any study
  • Keep it simple
  • Detailed specifications with Medical
  • Standardization concepts work!

11
Moving Forward
  • Global Kits with multi-lingual labeling
  • For all multi-national trials, always seems like
    a good solution
  • Can you effectively decide countries soon enough?
  • Do you have an effective translation regulatory
    approval process?
  • One country can delay the world
  • Consider Phased approach

12
Moving Forward
  • Package Design
  • Study concept driven
  • Bottles vs Blisters
  • Need to keep patient compliance as the primary
    driver
  • Kit Flexibility
  • Can one kit type be used for the entire study?
  • Directly affects IVR design and functionality
  • Can any of your organizations standardization
    concepts fit the study needs??

13
Moving Forward
  • Logistics
  • Definitive plan for assessing the supply chain
    logistics
  • Depot considerations
  • Direct to site vs affiliate involvement
  • Temperature control and validation of shippers
  • EU regulations
  • Carrier/delivery level considerations

14
Continuing Risk Assessment
  • As protocol continues development, risk/reward
    assessments with your clinical partner must
    continue.
  • Countries Labels, regulations, regulatory
  • IVR
  • Comparator
  • Stability
  • Package Design Perhaps even some primary
    packaging activities
  • Logistics

15
Onward!!
  • Operational execution/excellence
  • No matter the level of expertise, capacity and
    operational savvy, 16 weeks of work can not be
    done in 4 weeks….or can it??
  • Parallel vs sequential activity planning
  • Requires communication among operational
    functions involved
  • Low level risks
  • Manufacturing and packaging at risk

16
Onward!!
  • Leverage internal expertise and strengths
  • Consider contractor involvement
  • Capacity
  • Expertise outside of core competency
  • Engineering solutions
  • IS/IT solutions
  • Key factor is earliest possible decision to
    outsource (I.e the planning stage)

17
Onward!!
  • Partial vs complete study supply preparation
  • Realistic view of how fast study might enroll
  • Might one region of the world come on several
    weeks before another?
  • IVR design…flexibility of kits to be used for any
    patient/visit combination

18
Onward!!
  • Communication Things will change..does your
    relationship, organization strive for constant
    feedback about study start timelines or other
    critical study parameter changes??
  • Continual timeline adjustments
  • Hallway chats!! Are you visible?

19
How??
  • Spending the time and resources to be involved
    from day 1
  • Providing a service and expertise focused on
    solutions….not how hard/complicated my job
    is….Providing the Yes if..answer
  • Gaining trust and respect from your Clinical
    colleagues

20
How??
  • Shared Risk assessment and actions
  • Defined formal and informal communication
    channels
  • Creative solutions
  • Hitting your Hot Spot
  • Ethical, professional behavior

21
How??
  • Dedication to Planning Too many times we claim
    that this business can not be planned…I think
    quite the opposite. Plan with gusto the bits and
    pieces that can be planned….dedicate yourself to
    it….it will eventually allow you more time and
    energy to deal with the events that truly can not
    be planned or controlled…..and they will happen!!

22
Labeling Concepts
  • Practical Considerations
  • Style…
  • Multi-Lingual Labeling
  • Just-In-Time (JIT) Concepts
  • Exp. Dates and the EU

23
Practical Considerations
  • 1 Ensure focus remains getting the correct
    label on the correct container….not theres a
    broken letter in the caution statement.
  • Ensure Identifying number usage instructions
    are the most visible (size).
  • Ensure Exp./retest date information is in a place
    where it can be easily updated.

24
Practical Considerations
  • Label text has two main purposes….
  • Does it give the patient/subject the best chance
    of understanding how to correctly take the
    medication
  • Does it give the site dispensing the medication
    the best opportunity to give the correct
    medications to the patients/subjects
  • FOCUS on these

25
Style
  • One panel…two panel…three panel…booklet
  • No IVRS Two or three panel is appropriate on
    the dispensing unit…all others should be one
    panel.
  • IVRS Leverage the system capabilities/control
    and consider one panel labels for ease of
    application AND site efficiency.

26
Style - Booklet Labels
  • All the Rage!! Excellent choice for
    multi-lingual presentations…..but
  • Will one country in the world be rate limiting to
    study initiation?
  • How efficient is your translation/regulatory
    approval process?
  • Consider practical country groups as a strategy

27
Multi-Lingual Labeling
  • 1 concept employed in global trials today.
  • Booklets
  • Standard labels
  • Blister cards
  • Boxes and cartons

28
Exp. Dates and the EU
  • New regulations in the EU clearly state that if
    dates are controlled by electronic (IVRS) like
    systems that Exp. Dates DO NOT need to be on the
    container (similar to the US regulations)
  • Time will tell the application of this in trials,
    but we should challenge and support this.
  • Some trials HAVE been done with this principal.

29
JIT Labeling
  • Concept that all or some of the labeling is added
    just in time….typically at the time of
    distribution.
  • Most commonly used for Exp./retest dates
  • Can be a powerful tool
  • In my opinion, must be controlled electronically
    i.e. barcodes or vision systems

30
Multi-Lingual Labeling
  • Practical Considerations
  • Off-set print as much as practical
  • Even more critical to keep in mind general
    labeling considerations like unit identifier and
    instruction clarity/size
  • Critical to use universal symbols like the moon
    and sun
  • Challenges as discussed with booklets….
  • Do not let the label challenge FPV!

31
Packaging Concepts
  • Package Types and Stability
  • Blinding Considerations
  • Standardization Concepts
  • Start At The End
  • Automation
  • Total Control

32
Package Types
  • Package type and style should have only one
    guiding principal
  • Patient Compliance…never compromise
  • When packaging for IVR studies consider packaging
    to the lowest common denominator…increases
    flexibility
  • Consider the site storage situation

33
Package Types
  • Consider the dosing regimen and the possible
    affect that may have on the card size/style….if a
    dose is needed at mid-day, the card should be
    able to be carried with the patient easily
  • Consider ease of machine set up and flexibility
    of short run operations in material/component
    choices

34
Stability
  • Dont wait until the protocol is finalized.
  • Utilize standard materials/components
  • Apply bracketing principals
  • Consider comparators at the program level and get
    them on stability…they can always be stopped
  • Perfect low risk…high reward scenario

35
Blinding Considerations
  • Most common way to un-blind site personnel is
    with packaging issues
  • Label placement differences
  • Different color shades
  • Multiple component lots
  • Regular use of multi-room/shift packaging
    strategies

36
Blinding Considerations
  • Use strict control of packaging components to
    avoid small visual differences
  • Use as many visual aids as possible
  • 3-D drawings
  • Digital pictures
  • Samples
  • Dont forget tamper seal placement as well!!

37
Standardization Concepts
  • They work!
  • Film and foil
  • Bottling components
  • Standard card types
  • Standard terminology
  • Label stock/style
  • Can sometimes borrow stock components from the
    commercial side of the business……BUT
  • Proceed with caution

38
Start at the End
  • Today the logistics involved with global CTM
    materials can be as or perhaps even more complex
    than the packaging. Consider the warehousing,
    distribution and handling of the goods at the
    planning stages.

39
Start at the End
  • Consider….
  • Single layer pack outs…especially for IVRS type
    studies
  • Identifying any pre-pack activities that can
    happen prior to distribution
  • IVRS……Sequential vs. Random kit identifiers
  • Random may be better, but pack out and IVR
    coordination are critical. Safer if used with
    electronic checking means as well

40
Automation
  • Look for every opportunity to automate any part
    of the process possible
  • Best for large long term trials or entire
    programs
  • Need for early planning with engineering
  • Validation and testing
  • May require specific IS controls and systems
  • More validation and testing!

41
Total Control
  • Concept of utilizing barcodes to
  • Verify and count labels in printing operation
  • Control and verify packaging processes
  • Verify correct item is shipped to site
  • Record product returns for reconciliation purposes
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