proposed changes to the united states pharmacopeia (usp ... · • ich –stability studies • usp...

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Proposed Changes to the United States

Pharmacopeia (USP) <659> <1079> MKT

How these changes may impact you

Mark Maurice

Senior Project Manager / Industrial Engineer

Professional Services

FlyPharma Conference – Miami

September 11, 2018


22

Agenda

• Introductions

• Who are we?

• Familiarity

• Who is the USP / FDA / IATA

• Above and below 1000

• History

• USP <1079>

• USP <659>

• MKT

• How to review and submit comments

• Other important documents


33

Introductions


44

Who are we?

Manufacturers, Wholesalers, Pharmacists,

3PLs, Warehouse, Transportation, Service

Providers, Other


55

Familiarity

How many of you have read and understand

USP <1079>


66

Familiarity


USP <659>


77

Familiarity


MKT


88

Who is the USP / FDA / IATA?


99

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


1010

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


1111

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


1212

What does it mean if the USP

assigns a document above or

below 1000?


1313

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


1414

History

• ICH – Stability Studies

• USP <1079> - Released 2005 – Guidance document on how to manage temperatures, with specific temperature ranges defined.

• USP <1079> - Released 2013 – Much more detailed, QMS, MKT added

• USP <659> - In 2016 temperature definitions moved from USP <1079> to USP <659> and defined as Storage Conditions, Storage conditions include distribution, MKT still in USP <1079>


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USP <1079> 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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What’s been included

• Scope

• Risk mitigation strategies

– Documentation

– Training

– Resources

– Qualification/Validation


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Scope

• Manufacturers

• Repackaging

• Wholesalers and Distributors

• Pharmacies and Compounding Centers

• Hospitals and Healthcare Providers

• Brokers

• Freight Forwarders

• 3PLs

Source: www.usp.org


1818


Risk Based Approach

Source: www.usp.org


1919


Risk Table

Source: www.usp.org


2020


Documentation

• Quality Manual

• Standard Operating Procedures (SOPs):

Controlled, Owners, Approvers, Effective

Dates, Revisions, Scheduled Reviews

Source: www.usp.org


2121


Training

• Trainers

• Training types

• SOPs

• Job roles assigned

• Measure of effectiveness

• Retraining schedule

Source: www.usp.org


2222


Resources

• Storage– Security

– Segregation

– Environmental Controls – References <659>

• 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


2323


Validation

• Only spaces that are thermostatically controlled and are stationary

• Software used for accept / reject

Qualification

• Temperature mapping

• Facilities, vehicles, and packaging

• References <1118>

• References ASTM, ISTA, WHO, and PDA

Source: www.usp.org


2424


Calibration

• Temperature recording devices

• NIST, e.g.

Source: www.usp.org


2525


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 <1079>

• 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 <659> and <1079> 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


2727

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

• <659> and <1079>

• 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-forum

https://login.usp.org/cas/login?service=http://www.usppf.com/pf/login


2828

I would like to thank Chris

Anderson and Desmond Hunt

for their assistance in

understanding the new USP

documents.


2929

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 <1079.1> 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]