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AAPS Mini Symposium
Frozen State Storage and Cold Chain Transportation
Storage & Shipping of Biopharmaceuticals
USP General Chapter <1083>
Good Distribution Practices
Latest Guidance Developments
Mary G. Foster, PharmD, USP Chair
Packaging, Storage & Distribution Expert Committee 2015-2020
June 9, 2015, San Francisco
United States Pharmacopeia Packaging, Storage and
Distribution Expert Committee & Process
Revision General Chapter <1079> Good Distribution
Practices (now <1083>)
Guidance latest developments
– Frozen, refrigerated & controlled room temperature bio/pharma
product
2
Agenda
• GC = General Chapter
• EMS = Environmental Management System
• EP = Expert Panel
• GDP = Good Distribution Practices
• I/E = Import/Export
• PSD EC = Packaging Storage & Distribution Expert
Committee
• QMS = Quality Management System
• SC = Supply Chain
• SME = Subject Matter Expert
• USP = United States Pharmacopeia
Packaging, Storage and Distribution Expert Committee
3
Developing & updating USP standards for packaging
systems & their materials of construction (e.g., Containers:
metal, glass, plastic, elastomeric closures for injections)
Revising packaging definitions (e.g., CRT); packaging &
storage requirements for compendial articles
Creating and revising guidance; examples:
– Good distribution practices
– Containers: Performance testing
– Sterile product packaging: Integrity & evaluation
– Good packaging & repackaging practices
– Extractables
– Leachables
Goals of PSD Expert Committee
4
2010-2015 – ends May 2015
USP Liaison: Desmond Hunt
Government Agencies
– FDA: Don Klein, Vaikunth Prabu, and Brian Rogers
– Health Canada: Sarah Skuce
Academia: Marv Shepherd
Industry Manufacturing: Shirley Feld, Dennis Jenke, Dan Malinowski,
Dan Norwood, Kevin O’Donnell
Industry Consultants: Chris Chandler, Dana Guazzo, Devinder Pal,
Mike Ruberto
Industry Suppliers: Diane Paskiet
Chair: Mary Foster and Vice-Chair: Michael Eakins
2015-2020 – begins June 2015
PSD EC Members
5
5- Year Work Plan
Working teams
– Subcommittees: Internal EC members
– Expert Panels: External SME working teams
Workshops
Education programs; webinars
Conclaves – SME from all facets
Meetings
– Bi-monthly telecoms
– Annual face-to-face/USP Bethesda office
– Telecoms
– Minutes & Action Items
6
USP PSD EC Standard Way of Working
<1083.1> <1083.2> <1083.3> <1083.4>
Chapter Structure
GDP Subjects Divided into Sub-Chapters
<1083>
• Sub-chapter process – 4 form foundation
• Leads to infinite number of subjects, as needed
8
Supply Chain Management - Handling Biopharma
Scope: Applies to all organizations & individuals involved with packaging
materials & product, regardless of their category
Intended: Finished drug products (GC <1079>) & excipients (GC <1197>)
Also, Intended for,
• API’s & Excipients * Dietary supplements
• Medical devices; combination products * Radioactive products
• Biological /biotechnological products * Reagents & Solvents
• Cell & gene therapy products
• Clinical trial materials
• Not specifically called out: Medical gases
Covers: Diversion, cargo thefts, * SC integrity
• Counterfeiting; falsified medicine - Importation
• Traceability of products & shipments - Exportation
Working Internal Departments & Engaging External Partners
9
Sub-Chapter <1083.1>
Quality Management System
(QMS)
<1083.1> <1083.2> <1083.3> <1083.4>
11
USP General Chapter <1083>
Good Distribution Practices
Responsibilities: Senior management & All Supply Chain partners
• QMS – 8 Standard practices, more depth
• Management responsibility
• Documentation
• Resources management
• Operations
• Complaints, deviations, returns, recalls, counterfeits, reprocessing, rework
• Monitoring & improvements
• Validation
• Regulatory affairs
• Framework: Quality Manual & Policy, SOPs, Master Plans, risk management,
communication, procurement
• Adulterated product handling
• Counterfeit handling
• Product or Service Quality Reviews 12
Quality Management System (QMS)
Applies to All Temp Products
Working with Internal Departments
14
12
Sub-Chapter <1083.2>
Environmental Control Management
<1083.1> <1083.2> <1083.3> <1083.4>
15
USP General Chapter <1083>
Good Distribution Practices
Environmental Control Management
<1083.2>
17
Environmental Control 2 Approaches:
1) Facilities, Equipment, Vehicles
2) Using packaging materials – thermal blankets,
temperature, stabilizers, light resistant materials, desiccants
Significant: Contingency plan for outages, breakdowns
• Prospective or concurrent PQ or monitor each shipment with
retrospective historical data & risk assessment to justify
shipping method
• Performance qualification
• Data monitoring: evaluation; communication
• Significant: Short term excursions: Combine stability data
from long-term & accelerated studies, Mean Kinetic Temp
(MKT), temp excursion studies & temp cycling studies
• CAPA 16
EMS – All Temp Conditions/All Products
Practically Speaking - EMS
15
…, all necessary environmental conditions &
other vulnerability should be accounted for
during material and product importation and
exportation…, which includes storage in bonded
warehouses and during transportation (in-transit storage).
“Only referencing bonded warehouses can give the
impression that other storage scenarios do not have to be
maintained appropriately.”
Consider: “Appropriate storage conditions should be
maintained at all times.” (not listing any entity, covering all
aspects of distribution which includes in-transit storage)
16
• Should we remove this statement?
• Replace it with a statement that covers the relative stability
and environmental sensitivity of the product, …?
• It is acknowledged that most companies ship outside el
labeled storage conditions but within allowable shipping
conditions.
• There may be excursions/events which occur and there
may be product quality impact which would be investigated
and still allow the product to be released based on stability
data, etc.…
The ability to maintain the product within specified labeled
environmental conditions, especially during transportation
1/2
Practically Speaking - EMS
17
Current: The ability to maintain the product within specified
labeled environmental conditions, especially during
transportation.
• What about stating, “…follow shipping protocol…”
Is it necessary to maintain specific labeling temp controls
during transportation?
How about …? The ability to maintain the product within
acceptable specified labeled environmental conditions, during
storage and especially transportation.
• Regulatory input: …, maintain label controls and manage
excursions using stability – to cover the manufacture; what
about the wholesaler?
USP – Editing Process
2/2
Practically Speaking - EMS
18
USP General Chapter <1083>
Good Distribution Practices
Sub-Chapter <1083.3>
Importation & Exportation Management
<1083.1> <1083.2> <1083.3> <1083.4>
18
Importation & Exportation Management
Intended to cover I/E processes
1. Business-to-business: All stakeholders (suppliers, brokers,
customers, …)
2. Business-to-government: Customs clearance,
documentation, port authorities
Knowledge of product & material
• International name(s), codes, hazards, classifications,
presentations
• Likelihood of theft; potential for abuse, counterfeiting,
diversion
• Contractual agreements to ensure security
Not intended to cover
• Importation & Exportation law
• Customs procedures (country specific) 19
20
Importation & Exportation Management
2013 UPS Survey
21
Sub-Chapter <1083.4>
Supply Chain Integrity and Security
<1083.1> <1083.2> <1083.3> <1083.4>
22
USP General Chapter <1083>
Good Distribution Practices
1. General: QMS, RMS, SOPs & regulatory requirements
2. Product knowledge: ID, use, vulnerabilities, hazards,
processes
3. Global sourcing knowledge: Partners, suspicious orders,
information systems, qualifications
Supply Chain Integrity
• Economically motivated adulteration
• Counterfeit & falsified
• Diversion (expired; recalled donated)
• Inadequate transportation &/or storage
Supply Chain Security
• Theft; loss prevention; layered defenses
• Understanding threats; vulnerabilities; geography; routing
• Investigation process
Supply Chain Integrity & Security <1083.4>
23
When creating the first final package design
consider GDP’s
Engage SC partners/organizations
All medicines, pharma/biotech, have same
requirements for temp control
Closing
27
The Future
GOOD DISTRIBUTION PRACTICES
<1083> Introduction
QUALITY MANAGEMENT
SYSTEM
<1083.1>
ENVIRONMENTAL CONDITIONS
MANAGEMENT
<1083.2>
IMPORTATION & EXPORTATION MANAGEMENT
<1083.3>
SUPPLY CHAIN INTEGRITY &
SECURITY
<1083.4>
Finished Drug
Products
<1083.5>
Excipients
<1083.6>
Clinical Trial
Materials
<1083.9>
Active Pharmaceutical
Ingredients
<1083.7>
Packaging Components &
Materials
<1083.8>
26
In-
Progress
Developing and updating USP standards for packaging
systems and their materials of construction (e.g.,
Containers: metal, glass, plastic, elastomeric closures for
injections)
Revising packaging definitions (e.g., CRT); packaging and
storage requirements for compendial articles
Creating and revising guidance; examples:
– Containers: Performance testing
– Sterile product packaging: Integrity & evaluation
– Good packaging & repackaging practices
– Extractables
– Leachables
– Good distribution practices
Goals of PSD Expert Committee
25
Submit an application to serve as an USP expert
volunteer: New, account-based online application
Promote the Call for Candidates to your
colleagues
Apply for current cycle’s Expert Panels
What other subjects would be of value as GDP
Sub-Chapters?
Questions? USP web site at www.usp.org
Contact USP at USPVolunteers@usp.org or
301-816-8151
Join the Challenge! Focus On The Future
28
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