Mary G. Foster, PharmD, USP Chair Packaging, Storage & Distribution Expert Committee June 9, 2015, San Francisco

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1 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 June 9, 2015, San Francisco

2 Agenda 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 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 2

3 Packaging, Storage and Distribution Expert Committee 3

4 Goals of PSD Expert Committee 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 4

5 PSD EC Members 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 begins June

6 USP PSD EC Standard Way of Working 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

7 Chapter Structure GDP Subjects Divided into Sub-Chapters <1083> <1083.1> <1083.2> <1083.3> <1083.4> Sub-chapter process 4 form foundation Leads to infinite number of subjects, as needed 8

8 Supply Chain Management - Handling Biopharma Working Internal Departments & Engaging External Partners 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 Medical devices; combination products Biological /biotechnological products Cell & gene therapy products Clinical trial materials Not specifically called out: Medical gases Covers: Diversion, cargo thefts, Counterfeiting; falsified medicine Traceability of products & shipments * Dietary supplements * Radioactive products * Reagents & Solvents * SC integrity - Importation - Exportation

9 USP General Chapter <1083> Good Distribution Practices Sub-Chapter <1083.1> Quality Management System (QMS) <1083.1> <1083.2> <1083.3> <1083.4> 9 11

10 Quality Management System (QMS) Applies to All Temp Products Working with Internal Departments 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

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12 USP General Chapter <1083> Good Distribution Practices Sub-Chapter <1083.2> Environmental Control Management <1083.1> <1083.2> <1083.3> <1083.4> 15 12

13 Environmental Control Management <1083.2> 17

14 EMS All Temp Conditions/All Products 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

15 Practically Speaking - EMS, 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) 15

16 Practically Speaking - EMS 1/2 The ability to maintain the product within specified labeled environmental conditions, especially during transportation 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. 16

17 Practically Speaking - EMS 2/2 USP Editing Process Is it necessary to maintain specific labeling temp controls during transportation? Current: The ability to maintain the product within specified labeled environmental conditions, especially during transportation. What about stating, follow shipping protocol 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? 17

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

19 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 20

21 USP General Chapter <1083> Good Distribution Practices Sub-Chapter <1083.4> Supply Chain Integrity and Security <1083.1> <1083.2> <1083.3> <1083.4> 21 22

22 Supply Chain Integrity & Security <1083.4> 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 23

23 Closing When creating the first final package design consider GDP s Engage SC partners/organizations All medicines, pharma/biotech, have same requirements for temp control 27

24 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> Active Pharmaceutical Ingredients <1083.7> Packaging Components & Materials <1083.8> In- Progress Clinical Trial Materials <1083.9> 26

25 Goals of PSD Expert Committee 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 25

26 Join the Challenge! Focus On The Future 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 Contact USP at USPVolunteers@usp.org or

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