Marv Shepherd, PSM president, Member USP Package Storage and Distribution Expert Committee, and Professor at the University of Texas at Austin speaks about updates to United States Pharmacopeia's good distribution practices.

1. United States Pharmacopeia
Good Distribution Practices Update
Marv Shepherd, Ph.D.
President
Partnership for Safe Medicines
Member
USP Package Storage and Distribution Expert Committee
Professor, University of Texas at Austin
Email: marvshepherd@austin.utexas.edu

2. Mission of United States Pharmacopeia
} “To improve the health
of people around the
world through public
standards and related
programs that help
ensure the quality,
safety and benefits of
medicines and foods.”
*

3. Purpose of USP
} 130 countries use USP standards
} USP-NF (National Formulary) contains
the specifications, storage, packaging
and other requirements. “Specifications”
are lists of series of specific tests and
acceptance criteria of drug substances or
excipients.
} USP-NF is the “official U.S. Drug
Compendium.”
*

4. Agenda
} Introduction
} Overview of Packaging Storage and Distribution
Committee (PSD) Expert Committee (EC)
} Goals of the PSD Expert Committee
} Processes of the Committee
} Reorganization of Good Distribution Practices
Chapter (1083)
*

5. Packaging, Storage & Distribution Expert Committee
*

6. Package, Storage and Distribution Expert Committee
Members
– USP Liaison: Desmond Hunt (USP)
– Govt Agencies: Sarah Skuce (Health Canada), FDA Liaisons: Don
Klein,
– Academia: Marv Shepherd (University of Texas)
– Industry Mfging: Shirley Feld (Sanofi), Dennis Jenke (Baxter), Dan
Malinowski (Pfizer), Dan Norwood (Boehringer Ingelheim), Kola
Stucker (BMS)
– Industry Consultants: Dana Guazzo (Rx Pax), Kevin O’Donnell
(Exelsus Cold Chain Management), Devinder Pal (Catalyst Pharma),
Mike Ruberto Material Needs Consulting), Chris Chandler (GS1 US);
– Industry Suppliers: Diane Paskiet (West)
– Chair: Mary Foster (Foster Group)
– Vice-Chair: Michael Eakins (Eakins and Associates)
*

7. Goals of the Packaging Storage and
Distribution Expert Committee
1. Developing and updating USP standards for packaging
systems and their materials of construction (metal, glass,
plastic, elastomeric).
2. Revising packaging definitions including storage
requirements for compendial articles.
3. Creating and revising guidance for the good distribution of
compendial articles; good packaging & repackaging
practices; extractable and leachable.
*

8. Working Process
– Subcommittees – within the Expert Committee(s)
– Expert Panels – external partner working teams
– Workshops
– Education programs; webinars
– Conclaves – experts from all facets discussion
– Bi-monthly telecoms; annual meetings
– Charter
– Minutes
– Action Items
*

9. UPS 2013 “Pain in the Chain”
Healthcare Survey
} UPS conducts an global annual survey of
healthcare suppliers to get their perceptions on the
concerns/issues in distributing health care
products, including pharmaceuticals. In 2013, they
surveyed 440 health care companies. The results
corresponds closely with the initiatives of the USP.
} http://www.ups.com/content/us/en/bussol/browse/industries/
pain-in-the-chain.html
*

10. *
2013 UPS Survey
Please note:
Product security ranked
higher than managing
supply chain cost in 2013

11. *
2013 UPS Survey Found
US/W EU - regulatory compliance
• Asia Pacific - product security

12. } Process: General Chapters (GC), Review/Revise
every 3 years
} Actions, this cycle:
– The two General Chapters on Good Distribution Practices
are being reviewed by two Expert Committees (EC)
• Package Storage Distribution EC review <1079> Good Distribution
Practices for Drug Products; Revision official Dec 1, 2012, [USP 35
(2)]
• Excipients EC: <1197> Good Distribution Practices For Bulk
Pharmaceutical Excipients; New chapter, official May 1, 2013
*
Current Process, Actions & Outcomes

13. Outcomes of this cycle:
– Significant: Collaboration with 4 Expert Committees:
1) Packaging, Storage and Distribution EC
2) Excipients EC
3) Dietary Supplements EC
4) Compounding EC
– Significant
– Proposed change is to have one overarching Good
Distribution Practices General Chapter <1083>
– With ‘sub-chapter’ structure: Good Distribution for Drugs
<1079> & Good Distribution for Excipients <1197> become
sub-chapters of chapter <1083>
1) 4 sub-chapters completed and 5 sub-chapters in writing
*

14. Current Process, Actions & Highlights
Chapter Structure
GDP Subjects Divided into Sub-Chapters
<1083>
<1083.1> <1083.2> <1083.3> <1083.4>
Significant:
• Pharmacopeia Forum 40 (2) Mar-Apr 2014; comments in from May 31, 2014
being edited now by Expert Committee
• Sub-chapter process – 4 form foundation; 5 started; next subjects up for
consideration
8

15. Significant Scope Changes
Scope: Applies to all
organizations & individuals
involved in any aspect ...
GC’s
<1079>
<1197>
Intended: drugs & excipients
… NOT Intended for
•API’s, Medical devices; gases
•Radioactive products, reagents &
Solvents
•CTM- no storage requirement
… NOT Intended To Cover,
•Counterfeiting; falsified medicine,
pedigrees, supply chain security, chain
of custody
Scope: Applies to all
GC
<1083>
organizations
& individuals involved with
packaging materials & product
regardless of their category…
Intended: drug products & excipients
Also, Intended for,
•API’s, Medical devices; combination
products, Radioactive products, reagents
& Solvents
Added: Dietary supplements; biological &
biotechnological; cell & gene therapy
… Intended To Cover,
•Counterfeiting; falsified medicine
•Traceability SC integrity, Cargo thefts,
Diversion
10
PLEASE NOTE: Applies to all organizations not just
traditional manufacturers, wholesalers, exporters
importers, etc.
It covers: Hospital to hospital, wholesaler or supplier
to pharmacy, mail order pharmacy to patient,
pharmacy to pharmacy, pharmacy to health care
facilities (i.e. long-term-care facility).

16. *
<1083>
Good Distribution Practices
USP General Chapter <1083>
Good Distribution Practices
Sub-Chapter <1083.1>
Quality Management System
(QMS)
<1083.1> <1083.2> <1083.3> <1083.4>
11

17. Significant: Quality Management System
(QMS)
Responsibilities
* Applicant holder, OTC (no
application) & repackager
GC’s
<1079>
<1197>
• QMS – 4 Management Systems
(MS)
1.Storage MS
2.Distribution MS
3.Environmental MS
4.Risk MS
• Refrigerators & freezers (not covered
yet in new work)
• Labeling (depth not covered yet in new
work)
Responsibilities
GC
<1083>
• * Senior management (all SC
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
12

18. Significant: Why not just use cGMPs & GDPs
from regulators or other sources?
} USP must cover all stakeholders
•May seem redundant to a few, but needed by smaller
companies, virtual firms or new business entities
•Compendial Standard – as such is translated into multiple
languages; not every country has a standard QMS
expectation
•Does not supersede or supplant national requirements
*
Quality Management System

19. *
USP General Chapter <1083>
Good Distribution Practices
Sub-Chapter <1083.2>
Environmental Control Management
<1083.1> <1083.2> <1083.3> <1083.4>
15

20. Environmental Conditions
Management
Temperature
* Monitoring
* Mapping
* MKT during storage
GC’s
<1079>
<1197>
Disribution Temp data loggers
•Significant: not covered
yet in new chapter
Mail delivery distribution not
covered yet in new chapter
Environmental Control 2
Approaches:
GC
<1083>
1) Facilities, Equipment, Vehicles
2) Using packaging materials – thermal
blankets, temp stabilizers, light
Significarnets: iCstoanntitn mgeantceyr ipallasn, dfoers oicuctaagnetss,
breakdowns
•Monitor each shipment with retrospective
historical data & risk assessment to justify
shipping method
•Data monitoring: evaluation; communication
• Significant: Short term excursions:
Combine stability data from long-term
& accelerated studies, temp studies
16

21. *
USP General Chapter <1083>
Good Distribution Practices
Sub-Chapter <1083.3>
Importation & Exportation Management
<1083.1> <1083.2> <1083.3> <1083.4>
18

22. Importation & Exportation
Management
<1079> No discussion
<1197> Covers
Audits, container seals,
GC’s
<1079>
<1197>
cargo inspection, customs,
brokers, trade rules, product
verification
• <1197> knowing product &
applicable regulatory requirements
• Supply agreements
Intended to cover I/E process:
1. Business-to-business – all
GC
<1083>
stakeholders (suppliers, brokers,
customers, …)
2. Business-to-government – customs
clearance, documentation, port
authorities
Knowledge of product & material
•Likelihood of theft, abuse,
counterfeiting, diversion.
•Contractual agreements to ensure
security
Not intended to cover:
•Importation & Exportation law
•Customs procedures (country specific)
19

23. *
Importation & Exportation
Management

24. *
USP General Chapter <1083>
Good Distribution Practices
Sub-Chapter <1083.4>
Supply Chain Integrity and Security
<1083.1> <1083.2> <1083.3> <1083.4>
22

25. <1083.4> Supply Chain Integrity & Security
<1079> Covers
SMS 1 line: Theft, diversion
& counterfeit
GC’s
<1079>
<1197>
<1197> Covers
1. Legal & illegal outlets
2. Packaging technologies
1. General: QMS, RMS, SOPs
& regulatory requirements
2. Product knowledge: ID, use,
vulnerabilities, hazards, processes
GC
<1083>
3. Global sourcing knowledge: Partners,
suspicious orders, information
systems
Supply Chain Integrity
•Economically motivated adulteration
•Counterfeit & falsified
•Diversion (expired; recalled donated)
•Inadequate transportation, storage
Supply Chain Security
•Theft; loss prevention; layered
defenses, understanding vulnerabilities,
geography, routing
23

26. 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>
• Bringing in new support, experts in each field for panels, suppliers
• Forming Expert Panels now! 26

27. Closing
Regulatory Compliance: No one regulatory authority/
organization can secure the supply chain
–Prevention through strengthened regulatory capacity and
tight supply chains (partnerships)
–Entity-to-Entity visibility & collaboration
– A collective response when substandard & counterfeit
products are found
– Product Security: Protection & Damage
Early and rapid detection of suspicious products
Solutions for security and damage
27

28. Join the Challenge !
} Submit an application to serve as an USP expert volunteer
} Apply for current cycle’s Expert Panels
} What other subjects would be of value as GDP Sub-
Chapters?
} Questions?
} Visit the USP web site at www.usp.org
} Contact USP at USPVolunteers@usp.org or
301-816-8151
28

29. Thanks
A special thanks goes to Dr. Mary Foster,
Chair USP Packaging Storage and
Distribution Expert Committee. She was
extremely helpful to me in putting this
presentation together.

30. 29