USP General Chapter <1079> Pharmacopeia Forum Good Storage and Transportation Practices Good Storage and Transportation Practices for Drug Products IAT A Vancouver/March 8-12, 2010 Mary Foster, PharmD USP E tC itt M b 2005 2010 USP Expert Committee Member, 2005-2010 Packaging, Storage and Transportation Vice President, Quality 30 Catalent Pharma Solutions, Inc.
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USP General Chapter <1079>
Pharmacopeia Forum
Good Storage and Transportation PracticesGood Storage and Transportation Practices
for Drug Products
IATAVancouver/March 8-12, 2010
Mary Foster, PharmDUSP E t C itt M b 2005 2010USP Expert Committee Member, 2005-2010Packaging, Storage and Transportation
Vice President, Quality
30
Catalent Pharma Solutions, Inc.
Agenda
Introduction to <1079>ThemesThemes
Management Systems ApproachPractices to Support Drug Product Integritypp g g yAccountability Throughout Chain of CustodyTransparency Throughout Chain of Custody
How To Use Guide
31
Introduction to Revised General Chapter <1079>
• CurrentAi d t hi ll l li d ti iti i ithi– Aimed at geographically localized activities, i.e. within NA
– Discusses distribution chain in separate entities termsDiscusses distribution chain in separate entities terms
• Revision in Pharmacopeia Forum– Global application and accountabilityGlobal application and accountability – Discusses complexity within distribution chain and
containers; railcars; ships; trucks (large and small)• Including Emergency Medical Services (EMS) vehicles
and ambulances (removed from USP <1070>)• Mail distributors (postal services; expedited mailMail distributors (postal services; expedited mail
services, e.g. DHL; FedEx)• Excludes APIs & excipients, however …
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Systems
Themes <1079>
To provide a management systems approach• Life-cycle management based on science evidence &Life cycle management based on science, evidence &
justification• Improve efficiency in the supply chain• Definitions to the systems in the context of storage &
transportationQuality Management System• Quality Management System
• Storage Management System• Environmental Management SystemEnvironmental Management System • Transportation Management System• Risk Management System
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g y
Practices
Themes <1079>
• To provide a management systems approach
To recommend standard practices including controls and SOPs
• All drugs not just cold chain• All drugs - not just cold chain• All operational space• All entitiese t t es
35
Accountability
Themes <1079>
• To provide a management systems approach
• To recommend standard practices
• To discuss accountabilityy• Ensure drug life-cycle• Safety, identity, strength, quality, and purity • Joint venture throughout supply chain
36
USP General Chapter <1079> Revision ThemesGood Storage and Transportation Practices for Drug Products
Systems
1
Practices
2
Accountability
3
Systems Practices Accountability
37
USP General Chapter <1079> Revision ThemesGood Storage and Transportation Practices for Drug Products
Systems
1
Practices
22
Accountability
33
Systems Practices Accountability
38
Systems
Management Systems Approach
Quality Management System
(QMS)
Environmental Management System (EMS)
Storage Management System (SMS)
Transportation Management System (TMS)
Risk Management System
(RMS)
39
Systems
Management Systems Approach
Environmental Management
S t (EMS)
Storage Management
System (SMS)
Quality Management
System (QMS)
Transportation Management
S t (TMS)System (EMS)System (SMS)System (QMS) System (TMS)
Risk Management System (RMS)
<1079> QMS
• Set of policies, processes & procedures (SOPs) that enable the identification, measurement, control and improvement of the storage and transportation of drug productp
• Defined roles and responsibilities
• Purposefully building documented alliances [e g
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• Purposefully building documented alliances [e.g., Quality Agreements or Collaborative Agreements]
Systems
Management Systems Approach
<1079> QMS = Set of policies, processes & procedures that enable the identification, measurement, control and improvement of the storage and transportation of drug product
Quality Management
System (QMS)
SOPs/Defined roles/Collaborative Agreements …• Establish load configurations in cargo hold areas• Sub-contracted or non-dedicated vehicles used in airport
transportation to/from aircrafttransportation to/from aircraft• Document deviations and investigations to defined root
<1079> QMS = Set of policies, processes & procedures that enable the identification, measurement, control and improvement of the storage and transportation of drug product
Quality Management
System (QMS)
SOPs/Defined roles/Collaborative Agreements …• Measuring key elements to ensure procedures are
adequately followed from receipt to delivery• Controlling critical parameters to ensure storage andControlling critical parameters to ensure storage and
transportation conditions have been appropriate …while in their control
• Understand requirements of all relative drug regulatory agencies within own country; and, global regulatory agency
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age cy
Systems
Management Systems Approach
Environmental Management S t (EMS)
Storage Management
S t (SMS)
Quality Management
S t (QMS)
Transportation Management
S t (TMS)System (EMS) System (SMS)System (QMS) System (TMS)
Risk Management System (RMS)
<1079> EMS
• A section of the QMS that covers• A section of the QMS that covers environmental controls, including an adequate organization structure, roles & responsibilities,organization structure, roles & responsibilities,
• SOPs/policies/standards and processes for developing and maintaining an environmental
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developing and maintaining an environmental program
Systems
Management Systems Approach
<1079> EMS = A section of the QMS that covers environmental controls, including an adequate organization structure, roles & responsibilities, SOPs/policies/standards and processes for
Environmental Management S t (EMS) p , p p
developing and maintaining an environmental program.
Environmental controls/roles/SOPs
System (EMS)
• Over the life-cycle stability profile of products - airline time included
• Building stability profiles that cover potential excursions• Building stability profiles that cover potential excursions based on travel - airline cargo areas; tarmacs; airline hold areas
C• Resolutions to CAPA’s; preventive programs put in place(e.g., alert mechanism for temp breaches)
• Requiring SOPs, documentation and justifications
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q g , j• Symbols and icons
Systems
Management Systems Approach
Environmental Management
S t (EMS)
Storage Management S t (SMS)
Quality Management
S t (QMS)
Transportation Management
S t (TMS)System (EMS) System (SMS)System (QMS) System (TMS)
Risk Management System (RMS)
<1079> SMS
• Program to provide continuous improvement in the storage of drug products with key locations
• Buildings and facilities; vehicles and dispensing areas
• Basic processes
• Receiving/transferring; storage/holding
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g g g g
Systems
Management Systems Approach
<1079> SMS = Program to provide continuous improvement in the storage of drug products with key locations in buildings and facilities, vehicles and dispensing areas.
Storage Management S t (SMS) , p g
Storage program locations/processesA d t t l (b i t i t fi
Transportation Management S t (TMS)System (EMS) System (SMS)System (QMS) System (TMS)
Risk Management System (RMS)
<1079> TMS
• Provide continuous improvement of drug product• Provide continuous improvement of drug product lifecycle by better and more efficient use of transportation processestransportation processes
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Systems
Management Systems Approach
<1079> TMS = Provide continuous improvement of drug product lifecycle by better and more efficient use of transportation processes
Transportation Management S t (SMS) p
Create transportation system that assures adequate product t ti dl f l ti
System (SMS)
protection regardless of location• Oversight program with accountability • Notification to regulatory authoritiesg y• Validation or qualification program for a vehicle should represent environmental extremes• Temp map report define areas unsuitable; the minimum and• Temp map report define areas unsuitable; the minimum and maximum time allowances/tolerances
48
Systems
Management Systems Approach
Environmental Management
S t (EMS)
Storage Management
S t (SMS)
Quality Management
S t (QMS)
Transportation Management
S t (TMS)System (EMS) System (SMS)System (QMS) System (TMS)
Risk Management
System (RMS)System (RMS)
<1079> RMS1079 RMS
A section of the QMS that covers the tools for determining how to handle deviations anddetermining how to handle deviations and excursions
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Systems
Management Systems Approach
RMS = <1079> A section of the QMS that covers the tools for determining how to handle deviations and excursionsRisk
Management S t (SMS)
Process and SOPs when storage condition is not maintainedP d h t i ti i b d t
System (SMS)
• Procedures when contamination is observed, e.g. pests, mold, moisture
• Security proceduresy p• Audit of transportation firms
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1 32
Systems
1
Accountability
3
Practices
2
51
Standard PracticesPractices
Storage and Transportation Management Systems
Process1 2 3 4
A WarehouseStorage
ReceivingTransferring
StoringHolding
Transporting Administering
StorageHold Areas
B Vehicles
C PharmaciesDispensers
D End Users
P t ti d t ti f t ll d t Li it f
52
Prevent preparation damage at times of uncontrolled storage. Limit time out of storage conditions. Monitor and control temperature and act on deviations.
Determine temperature, air flow, and load patterns. Monitor and control temperature and act on deviations.
Determine if temperature mapping is required.
Procedures and documentation required.
1
2
3
4
Practices
Standard Practices
Process1 2 3 4
Storage and Transportation Management Systems
A WarehouseStorage
ReceivingTransferring
StoringHolding
Transporting Administering
1 2StorageHold Areas
B Vehicles
3 4
C PharmaciesDispensers
D End Users
P t ti d t ti f t ll d t Li it f
53
Prevent preparation damage at times of uncontrolled storage. Limit time out of storage conditions. Monitor and control temperature and act on deviations.
Determine temperature, air flow, and load patterns. Monitor and control temperature and act on deviations.
Determine if temperature mapping is required.
Procedures and documentation required.
1
2
3
4
Practices
Standard Practices
Process1 2 3 4
Storage and Transportation Management Systems
A WarehouseStorage
ReceivingTransferring
StoringHolding
Transporting Administering
StorageHold Areas
B Vehicles -e.g. Aircraft 1 2
3 4C Pharmacies
Dispensers
3 4
D End Users
P t ti d t ti f t ll d t Li it f
54
Prevent preparation damage at times of uncontrolled storage. Limit time out of storage conditions. Monitor and control temperature and act on deviations.
Determine temperature, air flow, and load patterns. Monitor and control temperature and act on deviations.
Environmental conditions (temperature, humidity, light) controlled and monitored• Preventive Maintenance program in place
E i t l it i d i ti l lib t d tStorageHold Areas
B Vehicles
4
2
• Environmental monitoring devices routinely calibrated at preset intervals with alert mechanism• Communication within supply chain coordinated to
C PharmaciesDispensers
determine proper timing for receipt (and conversely be transported) - holidays, weekends or other forms of interruptionD End Usersinterruption• Important consideration international shipments - customs stage supply chain
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1. 3.2.
Systems
1.
Accountability
3.
Practices
2.
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Accountability
Accountability and Responsibility
Accountability and responsibility must be maintained from:Manufacturing through Administration
All entities along the supply chain - ensure they handle i t l f t t d th f tiappropriately for temperature and other causes of preparation
adulteration
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General
Concluding Points
• Intended to provide guidance on drug product life-cycle practices along the supply chain inclusive of all relative entities and the associated requirements that must be in place to protect preparations
• Joint venture mentality as an expression of the need for harmonization and transparency across all t k h ld f iti l l h i t hstakeholders for critical supply chain aspects such
as environmental excursions for the benefit of the patientpatient
• Equally important is to stay current and be ready to change as new solutions evolve