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Proposed Changes to the United States
Pharmacopeia (USP) MKT
How these changes may impact you
Mark Maurice
Senior Project Manager / Industrial Engineer
Professional Services
FlyPharma Conference – Miami
September 11, 2018
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Agenda
• Introductions
• Who are we?
• Familiarity
• Who is the USP / FDA / IATA
• Above and below 1000
• History
• USP
• USP
• MKT
• How to review and submit comments
• Other important documents
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Introductions
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Who are we?
Manufacturers, Wholesalers, Pharmacists,
3PLs, Warehouse, Transportation, Service
Providers, Other
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Familiarity
How many of you have read and understand
USP
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Familiarity
How many of you have read and understand
USP
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Familiarity
How many of you have read and understand
MKT
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Who is the USP / FDA / IATA?
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USP – United States Pharmacopeia
USP
• Mission: To improve global health through public standards and
related programs that help ensure the quality, safety, and benefit
of medicines and foods.
• Vision: USP envisions a world in which all have access to high
quality, safe, and beneficial medicines and foods. USP approaches
this vision with a sense of urgency and purpose, strengthened by
its cadre of dedicated expert volunteers, members, and staff, and
by working collaboratively with key stakeholders across the
globe.
Source: www.usp.org
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FDA – United States Food and Drug
Administration
Mission: The Food and Drug Administration
is responsible for protecting the public health
by ensuring the safety, efficacy, and security
of human and veterinary drugs, biological
products, and medical devices; and by
ensuring the safety of our nation's food
supply, cosmetics, and products that emit
radiation.
Source: www.fda.gov
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IATA – International Air Transport
Association
Vision: To be the force for value creation and innovation
driving a safe, secure and profitable air transport industry that
sustainably connects and enriches our world.
Mission: To represent, lead, and serve the airline industry.
• Representing the airline industry– We improve understanding of
the air transport industry among decision makers and
increase awareness of the benefits that aviation brings to
national and global economies. Advocating for the interests of
airlines across the globe, we challenge unreasonable rules and
charges, hold regulators and governments to account, and strive for
sensible regulation.
• Leading the airline industry– For over 70 years, we have
developed global commercial standards upon which the air
transport industry is built. Our aim is to assist airlines by
simplifying processes and increasing passenger convenience while
reducing costs and improving efficiency.
• Serving the airline industry– We help airlines to operate
safely, securely, efficiently, and economically under clearly
defined rules. Professional support is provided to all industry
stakeholders with a wide range of products and expert services.
Source: www.iata.org
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What does it mean if the USP
assigns a document above or
below 1000?
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What does it mean if the USP
assigns a document above or
below 1000?
Above 1000 is a Guidance Document
Below 1000 is fully enforceable by the FDA
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History
• ICH – Stability Studies
• USP - Released 2005 – Guidance document on how to manage
temperatures, with specific temperature ranges defined.
• USP - Released 2013 – Much more detailed, QMS, MKT added
• USP - In 2016 temperature definitions moved from USP to USP
and defined as Storage Conditions, Storage conditions include
distribution, MKT still in USP
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USP Proposed Changes
Current
• Title – Good Storage and Distribution Practices for Drug
Products
• Good Practices Approach
Proposed
• Title – Risk Mitigation Strategies for the Storage of Finished
Drug Products
• Risk-Based Approach
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USP Proposed Changes
What’s been included
• Scope
• Risk mitigation strategies
– Documentation
– Training
– Resources
– Qualification/Validation
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USP Proposed Changes
Scope
• Manufacturers
• Repackaging
• Wholesalers and Distributors
• Pharmacies and Compounding Centers
• Hospitals and Healthcare Providers
• Brokers
• Freight Forwarders
• 3PLs
Source: www.usp.org
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USP Proposed Changes
Risk Based Approach
Source: www.usp.org
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USP Proposed Changes
Risk Table
Source: www.usp.org
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USP Proposed Changes
Documentation
• Quality Manual
• Standard Operating Procedures (SOPs):
Controlled, Owners, Approvers, Effective
Dates, Revisions, Scheduled Reviews
Source: www.usp.org
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USP Proposed Changes
Training
• Trainers
• Training types
• SOPs
• Job roles assigned
• Measure of effectiveness
• Retraining schedule
Source: www.usp.org
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USP Proposed Changes
Resources
• Storage– Security
– Segregation
– Environmental Controls – References
• Transportation– Maintain product quality
– Integrity
– Security
• Personnel– Hired based on government law requirements for
the
handling of drugs
– Job description
– Training requirements
Source: www.usp.org
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USP Proposed Changes
Validation
• Only spaces that are thermostatically controlled and are
stationary
• Software used for accept / reject
Qualification
• Temperature mapping
• Facilities, vehicles, and packaging
• References
• References ASTM, ISTA, WHO, and PDA
Source: www.usp.org
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USP Proposed Changes
Calibration
• Temperature recording devices
• NIST, e.g.
Source: www.usp.org
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USP Proposed Changes
Packaging and Storage Requirements
• Storage is the holding of product in facilities or
transportation units.
• Controlled Cold– Past USP tried to define as 0C to 15C for
less
than 24 hours with less than 8C MKT
– Problem was 0C and the risk of freezing
– Proposed is 2C to 15C as long as 8C MKT is not exceeded
• MKT definition added – moved from
• Reference to Stimuli Article
Source: www.usp.org
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MKT Stimuli Article
The Use of Mean Kinetic Temperature to Aid Evaluation of
Temperature Excursions: Proper and Improper Applications
• Revision process to and by Chris Anderson, Robert Seevers, and
Desmond Hunt
• Controlled Room Temperature – Calculation from the end of the
excursion back 30 days or the average time you have product in your
possession
• Controlled Cold – Calculated from the end of the excursion
back 24 hours
Source: www.usp.org
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How to Review and Submit Comments
• http://www.usp.org/get-involved/comment-proposed-standards
• https://www.uspnf.com/pharmacopeial-forum
• Access PF Online
• Need Login – Create
•
https://login.usp.org/cas/login?service=http%3A%2F%2Fwww.usppf.com%2Fpf%2Flogin
• Volume 44
• PF 44(4)
• In Process Revisions
• General Chapters
• and
• Comments must be submitted prior to 30 September 2018
• Easier Yet – See me after the presentation with your card and
I will email documents and comment submission form.
Source: www.usp.org
https://urldefense.proofpoint.com/v2/url?u=http-3A__www.usp.org_get-2Dinvolved_comment-2Dproposed-2Dstandards&d=DwMF-g&c=ilBQI1lupc9Y65XwNblLtw&r=oDMvhd1_nfBqloN7Cfr-q5ROuBMY4HCe6cFYCInYszU&m=OL2XjnlmGcphcXMBlE-VWwpnovw_-S_mcvY3Ek-SquQ&s=xE1OnFYAx6OGBxdSCJbQhUp2VO3WDopR7rzp2RXY9C4&e=https://www.uspnf.com/pharmacopeial-forumhttps://login.usp.org/cas/login?service=http://www.usppf.com/pf/login
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I would like to thank Chris
Anderson and Desmond Hunt
for their assistance in
understanding the new USP
documents.
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Other important documents
PDA – PCCIG – Pharmaceutical Cold Chain Interest Group
–Technical Reports
• TR 39 – Guidance for Temperature-Controlled Medicinal
Products: Maintaining the Quality of Temperature Sensitive
Medicinal Products through the Transportation Environment
• TR 46 – Last Mile: Guidance for Good Distribution Practices
for Pharmaceutical Products to the End User
• TR 52 – Guidance for Good Distribution Practices (GDPs) for
the Pharmaceutical Supply Chain
• TR 53 – Guidance for Industry: Stability Testing to Support
Distribution of New Drug Products
• TR 54 – Implementation of Quality Risk Management for
Pharmaceutical and Biotechnology Manufacturing Operations
• TR 58 – Risk Management for Temperature-Controlled
Distribution
• TR 64 – Active Temperature-Controlled Systems: Qualification
Guidance
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Other Important Documents• Seevers, R. H., and Bishara, R. H.:
Protecting the Quality of Clinical Trial Material During
Distribution: What Studies are Needed and When. Stimuli Article,
United States Pharmacopeia (USP) Forum 40 (6), 2014.
• Van Asselt, E. J., and Bishara, R. H.: Establishing and
Managing the Drug Product Stability Budget. Journal of
Pharmaceutical Outsourcing,Volume 16, Issue 4, July / August, 2015,
pp. 20 – 27.
• Bishara, R. H., Braga, G. K., Foster, M., Carrico, J., Jacobs,
S., Jeiven, M., Jolicoeur, C, Hunt, D.G., (Expert Panel), USP
Storage and Transportation of Investigational Drug Products. PF
42(4), 28 June, 2016.
• Majic, Z., Van Asselt, E., and Bishara, R. H.: Pharma by Air:
Equipment Qualification and Route Risk Assessment. Journal
Pharmaceutical Outsourcing, Volume 17, Issue 5, Sep/Oct, 2016, pp
26-31.
• Van Asselt, E. J., and Bishara, R. H., et. al.: Pharma
Requirements For Temperature Controlled Trailers. Journal of
Pharmaceutical Outsourcing, Volume 18, Issue 4, July / August 2017,
pp. 12 – 19.
• Van Diest, G-J., and Bishara, R. H., et. al.: Pharmaceutical
Supply Chain Security Risk Assessment for Shipping Lanes. Journal
of Pharmaceutical Outsourcing, Volume 18, Issue of
September/October 2017, pp. 16-25.
• Bruinink, R., and Bishara, R. H.: Lessons Learned from
Continued GDP Inspections in the Netherlands Based on the New EU
GDP Guidelines. Journal Pharmaceutical Outsourcing, Volume 19,
Issue 2, March / April 2018, pp. 16 - 17.
• Van Asselt, E. J., Schutte, L, and Bishara, R. H.: Last Mile
Shipping Conditions and Temperature Excursion Handling for Room
Temperature Pharma Products in Europe. Journal of Pharmaceutical
Outsourcing, Volume 19, Issue 4, July / August 2018, pp. 12 –
17.
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Thank You!
Mark MauriceSenior Project Manager – Industrial Engineer
Email: [email protected]
Phone: +1.978.720.2666
mailto:[email protected]