ANSI Homeland Security Standards Panel Global Supply Chain Security Standards and Annual Plenary Meeting Mary G. Foster, PharmD USP Chair, Expert Committee, Packaging, Storage & Distribution Aphena Pharma Solutions, VP Quality & Regulatory Affairs September 13, 2012 * ANSI-HSSP Workshop The FHI 360 Conference Center * Washington, DC 1
Understanding the SC Risks Raw Materials, Excipients, API’s , Clinical Trials , Medical Devices Manufacturing, Packaging, Storage, Distribution & Sales Industry Trends Business Models Increased supply chain • Increased global • Rise of emerging markets complexity outsourcing • Healthcare spending and risk • Increased partnerships • Regulation or lack thereof • Virtual companies • Supply chain breaches • No common ground What should the USP role be in providing guidance? 2
Standards for Drug Product Integrity Pharma Supply Chain & Anti-Counterfeiting Understanding the Current vs. Future Developing the threats State Mapping Strategy • What are the supply chain • What business • What is the future state security threats? departments are vision? involved? • How big is each threat? • What is the continuous • What are the key improvement plan? • What strategy should be processes? put in place? • How do our processes need • Define the action plan to change? • What countries around from a holistic approach the world are involved? • How do we ensure the end • What are the user receives drug product • Focus on risk mitigation & effectiveness evaluation that meets its identity, management actions needed? strength, quality, purity & safety? Guidance through USP General Chapter Good Distribution Practices 3 3
Supply Chain Management Overview Changes Future Trends Trends Changes Future Industry success factors Accelerated Medicines changing importation –New technologies to stay –Digital care competitive –New processes –India forecast 12% increase FDA regulated –Lifecycle changes Stricter regulations? No products 2010-2020 single set of rules Expertise driven Highly sensitive –Multiple standards: GMP, –Outsourcing >35 production processes GIP (importer), GDP, GPP different contractors (pharmacy practice) used New geographies –Greater pharmacovigilance Exportation driven –Increase in spectra of Expect collaboration & harm to end user –2002-2009 13% transparency increase drug –Threats: counterfeiting, importation FDA *thefts & diversion, –All along supply chain path regulated products; economically motivated –With regulators 150 countries; adulteration; 300,000 sites outside 4 *Cargo theft is on the rise globally, with a 350% increase from 2007 to 2009 in the US alone (CBS News)
Good Distribution Practices * General GDPs * SC Temp Management * Good Import/Export Practices * SC Integrity USP GC <1079> USP GC <1083> USP GC <1197> USP GC <xxxx> Good Storage & GDP – SC Integrity GDP for Bulk GDP Shipping Practices *PF Mar/Apr 2012; Pharma Excipients • <xxxx.1> Basic Industry input under *Official 2005 *Official USP 36 review - Expert Panel Guidance *Revision Dec1, 2012 • Provides • Describes • Provides recommendations • <xxxx.2> Pedigree recommended recommendations to GDPs practices on SC ensure GDP • Excipients only • <xxxx.3> Track & integrity • Drug Products: Trace • General GCP concepts • API’s, Excipients, Human, Vet, Clinical Drug Products, • Traceability discussed • General GDP • <xxxx.4> Medical Devices Concepts Serialization • Risks: adulteration & • Basic information contamination – not • Distribution is specific • <xxxx.5> Anti- • Discusses practices transportation to combat Counterfeiting • Importation – not • No practices on counterfeiting and specific combating packaging • <xxxx.6> Natural counterfeiting or • Pharmacy technologies Disasters technologies compounding 5
Pharma Good Distribution Practices (GDP) Looking Beyond the Obvious: GDP – Leading to USP Guidance Chapter(s) Understanding the SC Risks – Drug/Medical Device/Clinical Trial Finished Product , Active Pharma Ingredients (API), Excipients & Raw Materials; * PLUS * Packaging, Storage, Distribution Creating a Common-Sensed Mindset: PSD EC Workshop SC Integrity Outcomes Navigating to the Future: Strategic Plans for GDP GC; Ideas – Spectral Library GDP = Good Distribution Practices What Are We Missing? USP = United States Pharmacopeia SC = Supply Chain PSD EC = Packaging, Storage & Distribution Expert Committee GC = General Chapter 6
Global Forces Reshaping Pharma SCM Preparing for what’s next – Collaboration - people management internal and external resources • Partnerships where multi-companies act as one • understand competencies needed, establish program elements, train and continuously develop – Global operating model – Industry Standards • Information-rich • Corporate strategic priority • Global scale but local scope – Transparency Look to other industries – Innovation – Holistic approach – Effectiveness evaluation 7
8
Recommend
More recommend
