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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

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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

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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

links to all entities

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Introduction to Revised of General Chapter <1079>

• Drug Products (Human; Veterinary; Clinical Trial)• Manufacturers packagers; repackagers; wholesalers;• Manufacturers, packagers; repackagers; wholesalers;

distributors; hospital, mail-order and retail pharmacies• Contractor’s site; Laboratories • Transportation vehicles (aircraft; automobiles; vans;

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

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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

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USP General Chapter <1079> Revision ThemesGood Storage and Transportation Practices for Drug Products

Systems

1

Practices

2

Accountability

3

Systems Practices Accountability

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USP General Chapter <1079> Revision ThemesGood Storage and Transportation Practices for Drug Products

Systems

1

Practices

22

Accountability

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Systems Practices Accountability

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Systems

Management Systems Approach

Quality Management System

(QMS)

Environmental Management System (EMS)

Storage Management System (SMS)

Transportation Management System (TMS)

Risk Management System

(RMS)

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Systems


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


<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

cause(s)• Transparent change control• Self inspections; corporate audits; allow customer audits?

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Systems


<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


Environmental Management S t (EMS)

Storage Management

S t (SMS)

Quality Management

S t (QMS)


S t (TMS)System (EMS) System (SMS)System (QMS) System (TMS)


<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


<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



S t (EMS)

Storage Management S t (SMS)

Quality Management

S t (QMS)




<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


<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

System (SMS)

• Assures adequate controls (basics: extremes in temp, fire, water, explosion, pests)

• Prevent diversion

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Systems



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)


<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


<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

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Systems



S t (EMS)

Storage Management

S t (SMS)

Quality Management

S t (QMS)



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


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

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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

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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


A WarehouseStorage


StoringHolding


1 2StorageHold Areas

B Vehicles

3 4


D End Users


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1

2

3

4

Practices

Standard Practices

Process1 2 3 4


A WarehouseStorage


StoringHolding


StorageHold Areas

B Vehicles -e.g. Aircraft 1 2

3 4C Pharmacies

Dispensers

3 4

D End Users


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1

2

3

4

Practices

Standard Practices

Process1 2 3 4


• Environmental conditions (temperature humidity light)

A WarehouseStorage


StoringHolding


4

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


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

ManufacturingManufacturing DeliveryDelivery AdministrationAdministration

Supply Chain

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Accountability




Supply Chain - Responsible Entity

Applicant holder or manufacturer for non-application preparationspreparations

• Transparency: removed time frames from current chapter (upon 2 hours of receipt…)

f f ’

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• It should follow…for API’s, excipients

Accountability





Delivery process• RECALL - if it is found in any part of the supply chain to be

adulterated due to storage/transportation activities, including counterfeiting

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Accountability





Administration and End User Entities• Key to final safety, identity, strength, quality and purity

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Accountability





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

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change as new solutions evolve

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