PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribution Practices Update
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Transcript of PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribution Practices Update
United States PharmacopeiaGood Distribution Practices Update
Marv Shepherd, Ph.D.President
Partnership for Safe MedicinesMember
USP Package Storage and Distribution Expert CommitteeProfessor, University of Texas at Austin
Email: [email protected]
} “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.”
Mission of United States Pharmacopeia
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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.”
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} 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)
Agenda
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Packaging, Storage & Distribution Expert Committee
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– 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)
Package, Storage and Distribution Expert Committee Members
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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.
Goals of the Packaging Storage and Distribution Expert Committee
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– 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
Working Process
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} 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
UPS 2013 “Pain in the Chain” Healthcare Survey
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2013 UPS Survey
Please note:Product security ranked higher than managing supply chain cost in 2013
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US/W EU - regulatory compliance• Asia Pacific - product security
2013 UPS Survey Found
} 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
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Current Process, Actions & Outcomes
– Significant: Collaboration with 4 Expert Committees: 1) Packaging, Storage and Distribution EC2) Excipients EC3) Dietary Supplements EC4) 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
Outcomes of this cycle:
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Current Process, Actions & Highlights
<1083.1> <1083.2> <1083.3> <1083.4>
Chapter StructureGDP Subjects Divided into Sub-Chapters
<1083>
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
consideration8
Significant Scope Changes
Scope: Applies to all organizations & individuals involved in any aspect ...
Intended: drugs & excipients… NOT Intended for •API’s, Medical devices; gases•Radioactive products, reagents & Solvents•CTM- no storage requirement
GC’s<1079><1197>
… NOT Intended To Cover, •Counterfeiting; falsified medicine, pedigrees, supply chain security, chain of custody
Scope: Applies to all 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 & SolventsAdded: Dietary supplements; biological & biotechnological; cell & gene therapy
… Intended To Cover,•Counterfeiting; falsified medicine•Traceability SC integrity, Cargo thefts, Diversion
GC<1083>
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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).
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USP General Chapter <1083> Good Distribution Practices
Sub-Chapter <1083.1> Quality Management System
(QMS)
<1083> Good Distribution Practices
<1083.1> <1083.2> <1083.3> <1083.4>11
Significant: Quality Management System (QMS)
Responsibilities * Applicant holder, OTC (no application) & repackager
• QMS – 4 Management Systems (MS)
1.Storage MS2.Distribution MS3.Environmental MS4.Risk MS• Refrigerators & freezers (not covered
yet in new work)• Labeling (depth not covered yet in new
work)
GC’s<1079><1197>
Responsibilities• * 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
GC<1083>
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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
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Quality Management System
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USP General Chapter <1083> Good Distribution Practices
Sub-Chapter <1083.2> Environmental Control Management
<1083.1> <1083.2> <1083.3> <1083.4>
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Environmental Conditions Management
Temperature * Monitoring * Mapping * MKT during storage
Disribution
Temp data loggers•Significant: not covered yet in new chapter
GC’s<1079><1197>
Mail delivery distribution not covered yet in new chapter
Environmental Control 2 Approaches: 1) Facilities, Equipment, Vehicles2) Using packaging materials – thermal
blankets, temp stabilizers, light resistant materials, desiccantsSignificant: Contingency plan for outages,
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
GC<1083>
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USP General Chapter <1083> Good Distribution Practices
Sub-Chapter <1083.3> Importation & Exportation Management
<1083.1> <1083.2> <1083.3> <1083.4>
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Importation & Exportation Management
<1079> No discussion <1197> Covers Audits, container seals,
cargo inspection, customs, brokers, trade rules, product verification
• <1197> knowing product & applicable regulatory requirements
• Supply agreements
GC’s<1079><1197>
Intended to cover I/E process: 1. Business-to-business – all 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)
GC<1083>
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Importation & Exportation Management
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USP General Chapter <1083> Good Distribution Practices
Sub-Chapter <1083.4> Supply Chain Integrity and Security
<1083.1> <1083.2> <1083.3> <1083.4>
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<1079> Covers SMS 1 line: Theft, diversion & counterfeit <1197> Covers1. Legal & illegal outlets2. Packaging technologies
GC’s<1079><1197>
1. General: QMS, RMS, SOPs & regulatory requirements 2. Product knowledge: ID, use, vulnerabilities, hazards, processes3. 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
GC<1083>
<1083.4> Supply Chain Integrity & Security
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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!
NEW NEW NEW
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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 productsSolutions for security and damage
Closing
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} 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 [email protected] or
301-816-8151
Join the Challenge !
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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.
Thanks
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