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PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribution Practices Update

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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.

Published in: Health & Medicine

PSM Interchange 2014: Marv Shepherd, United State Pharmacopeia Good Distribution Practices Update

  1. 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. 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. 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. 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. 5. Packaging, Storage & Distribution Expert Committee *
  6. 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. 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. 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. 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. 10. * 2013 UPS Survey Please note: Product security ranked higher than managing supply chain cost in 2013
  11. 11. * 2013 UPS Survey Found US/W EU - regulatory compliance • Asia Pacific - product security
  12. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 23. * Importation & Exportation Management
  24. 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. 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. 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. 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. 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. 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.
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