Falsified Medicines and Drug Supply Chain Security Dr. Teri Stokes, Director GXP International, Concord, MA – USA www. GXPInternational.com

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EU Unique Identifier (UI) = 2D barcode (data matrix) set as carrier of UI UI Required Content = Manufacturer product code; Serial Number; National reimbursement number, if present; Batch Number, Expiry Date Becomes Active in 2018 (Ref EC Directive: Falsified Medicines Directive 2011/62/EC) EU Auditable Chain of Custody Slide 3

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  • 1 Falsified Medicines and Drug Supply Chain Security Dr. Teri Stokes, Director GXP International, Concord, MA – USA www. GXPInternational.com Email: drstokes@gxpinternational.com Online Compliance Training – Sept. 24, 2015
  • 2 Chain of Custody = Logging of Who, What, Where, When, Why, How and Required Approvals as per SOP Stakeholders’ Repository = Protected centralized database managed by stakeholders & supervised by EU authorities with End-to-End scanning process & verifications by wholesale distributors. (Ref. 2011 EC Directive: Falsified Medicines Directive 2011/62/EC) EU Auditable Chain of Custody Slide 2
  • 3 EU Unique Identifier (UI) = 2D barcode (data matrix) set as carrier of UI UI Required Content = Manufacturer product code; Serial Number; National reimbursement number, if present; Batch Number, Expiry Date Becomes Active in 2018 (Ref. 2011 EC Directive: Falsified Medicines Directive 2011/62/EC) EU Auditable Chain of Custody Slide 3
  • 4 Chain of Custody = Logging of Who, What, Where, When, Why, How and Required Approvals as per SOP DSCSA = FDA Drug Supply Chain Security Act aims to improve traceability of prescription drugs within the supply chain over a10 year period (Ref. FDA Drug Quality and Security Act – Title II Nov. 2013 ) US Auditable Chain of Custody Slide 4
  • 5 Each Step Focus = Focusing on each step to the pharmacy and back for returns Major Phase 1 = Lot-level traceability & verification by Jan. 1, 2015 for manufacturers, wholesalers & re-packagers (Ref. FDA Drug Quality and Security Act – Title II Nov. 2013 ) US Auditable Chain of Custody Slide 5
  • 6 Major Phase 2 = Unique Serialization. From 2017- 2019, single packages of drug products have to be marked with serialization numbers & bar codes. Major Phase 3 = Serialized Item-Level Traceability. From 2023, information must be provided to allow supply chain partners to trace transaction history back to initial manufacturer or re-packager. (Ref. FDA Drug Quality and Security Act – Title II Nov. 2013 ) US Auditable Chain of Custody Slide 6
  • 7 Serialization = Process of uniquely identifying a product. FDA issued recommendations in the Standard Numerical Identifier (SNI) Guidance. March 2010 Drug Package = The smallest unit placed into interstate commerce by manufacturer or re-packager that is intended for individual sale to the pharmacy or other dispenser of the drug product. (Ref. FDA Workshop Feb. 2011) Key Terms & Concepts: FDA Slide 7
  • 8 FDA Guidance for Industry: Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages Standardized Numerical Identification (SNI) Serialized National Drug Code (sNDC) NDC 55555 666 77 (labeler code + product code + package code) + SERIAL NUMBER 11111111111111111111 (unique, up to 20 characters) (Ref. FDA SNI Guidance, March 2010) Key Terms & Concepts: FDA Slide 8
  • 9 Interoperability = Compatible data & process standards to allow data sharing by integrating into the same system Authentication = Verifying that the Standardized Numerical Identification (SNI) on a prescription drug package is a valid number & confirm there are no discrepancies in the distribution history. (Ref. FDA Workshop Feb. 2011) Key Terms & Concepts: FDA Slide 9
  • 10 Track-and-trace data = Any information collected about each package from the point of manufacture to the point of dispense or destruction. Pedigree = Distribution history of a drug package. Status = Description of package disposition as it moves through the supply chain (e.g. recall in process, in transit, destroyed, dispense, stolen, etc.) (Ref. FDA Workshop Feb. 2011) Key Terms & Concepts: FDA Slide 10
  • 11 Data Management = Provides standardized mechanisms that supply chain participants use to capture, store, protect & utilize track-and-trace data to facilitate authentication & interoperability. Accountability = When a person or entity has to report, explain, justify, or be responsible for, or effectively takes custody or ownership of a package. (Ref. FDA Workshop Feb. 2011) Key Terms & Concepts: FDA Slide 11
  • 12 Counterfeit drug = A drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and … (Ref. FDA Workshop Feb. 2011) Key Terms & Concepts: FDA Slide 12
  • 13 Counterfeit drug = and …which thereby falsely purports or is represented to be the product of, to have been packed or distributed by such other drug manufacturer, processor, packer, or distributor. (FFDC Act) (Ref. FDA Workshop Feb. 2011) Key Terms & Concepts: FDA Slide 13
  • 14 Manufacturer & Contract Manufacturers Primary Distributor(s) Re-packager(s) Secondary Distributor(s) Pharmacies (Ref. FDA Workshop Feb. 2011) The Drug Supply Chain Slide 14
  • 15 Globalization of Supply Chains Criminal activities such as diversion, cargo theft, and counterfeiting Rules that vary by country & state Goods are stolen & reintroduced into the supply chain Counterfeit goods are sold to suppliers and re-enter the supply chain Drug Supply Chain Complexity Slide 15
  • 16 1.Prevent the introduction of counterfeit, diverted, sub potent, substandard, adulterated, misbranded, or expired drugs. 2.Facilitate identification of counterfeit, diverted, sub potent, substandard, adulterated, misbranded, or expired drugs. 3.Provide accountability for the movement of drugs by supply chain participants. 4.Improve efficiency and effectiveness of recalls. Track-and-Trace System Goals Slide 16
  • 17 1.Able to capture unique product identification & status of the number. 2.Ensures interoperability to enable supply chain participants to securely capture, store & exchange track- and-trace data accurately & efficiently. 3.Authenticates the SNI and entire distribution history of each package. 4.Enable appropriate access to track-and-trace data necessary to achieve system goals. Track-and-Trace System Attributes Slide 17
  • 18 5.Ensures security of data & systems from falsification, malicious attacks, and breaches. 6.Ensures confidential commercial information is protected. 7.Ensures patient privacy is maintained, if applicable. (Ref. FDA Workshop Feb. 2011) Track-and-Trace System Attributes Slide 18
  • 19 In General –The term “transaction” means the transfer of product between persons in which a change of ownership occurs. (Ref. Title II Drug Supply Chain Security. 2013) Transaction Slide 19
  • 20 The term “transaction history” means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product. (Ref. Title II Drug Supply Chain Security. 2013) Transaction History Slide 20
  • 21 A.The proprietary or established name or names of the product; B.The strength and dosage form of the product; C.The National Drug Code number of the product; D.The container size; E.The number of containers; F.The lot number of the product; G.The date of the transaction; H.The date of the shipment, if more than 24 hours after the date of the transaction I.The business name & address of person from whom ownership is being transferred J.The business name & address of person to whom ownership is being transferred (Ref. Title II Drug Supply Chain Security. 2013) Transaction Information Slide 21
  • 22 A statement, in paper or electronic form, that the entity transferring ownership in a transaction – A.is authorized as required under the Drug Supply Chain Security Act; B.received the product from a person that is authorized as required under the Drug Supply Chain Security Act; C.received transaction information and transaction statement from the prior owner of the product, as required under section 582; D.did not knowingly ship a suspect or illegitimate product; (Ref. Title II Drug Supply Chain Security. 2013) Transaction Statement Slide 22
  • 23 A statement, in paper or electronic form, that the entity transferring ownership in a transaction - E.had systems and processes in place to comply with verification requirements under section 582; F.did not knowingly provide false transaction information; and G.did not knowingly alter the transaction history. (Ref. Title II Drug Supply Chain Security. 2013) Transaction Statement Slide 23
  • 24 Beginning not later than January 1, 2015, a manufacturer shall - i) Prior to, or at the time of, each transaction in which such manufacturer transfers ownership of a product, provide the subsequent owner with transaction history, transaction information, and a transaction statement, in a single document in a paper or electronic format; and ii) Capture the transaction information (including lot level information), transaction history, and transaction statement for each transaction and maintain such information, history, and statement for not less than six years after the date of the transaction. (Ref. Title II Drug Supply Chain Security. 2013) Manufacturer Requirements Slide 24
  • 25 Track & Trace System Models Track & Trace System ManufacturerDistributorPharmacy IT Steps Generate SNI Scan SNI tag Apply SNI tag Record SNI & transaction Record data Authenticate Technology Needs Serialization software Tag scanners Data carrier technology (RFID, 2D barcode) Traceability & authentication software Database SW to store track & trace events
  • 26 FDA Device SW Val. GXP System Guidelines & Regulations Time 1990 1986 1980 2000 FDA Blue Book EU GMP Ax. 11 &GCP OECD GLP Computer Validation Directives - GXP Operations: GMP,GLP,GCP,ES... - Computerized Systems Component of Operations Impact of Computerized Systems ICH GCP 19951997 FDA Part 11 Japan GMP Use of Computerized Systems in the R&D & Manufacture of Drug Product FDA SW Guide Japan & UK GLP FDA CSUCT Slide 26 EC 94/95 Privacy 19832003 HIPAA 2003 PIC/S Guide Part 11 Scope 20052006 Sarbanes Oxley (SOX) HIPAA Security FDA cGMP 9/06 Japan Part 11 GAMP Guidelines Time Part 820 QMS FDA CSUCI 5/07 OECD GLP Archive 2007 FDA PRO Guide 2010 EU GMP Annex 11 EMA eSource & EDC
  • 27 Track-and-Trace Data Archive Plan Section Topic 1.Introduction Strategy, context & authority for Track/Trace System 2.Purpose Strategic issues & constraints (QA/IT/Regulatory/Management) 3.ScopePhysical/virtual location; organizational unit; transaction data sources; data owner; data type; data content; data collection; regulatory requirement Slide 27 This table adapted from GAMP Good Practice Guide: Electronic Data Archiving 2007 www.ispe.org
  • 28 Track-and-Trace Data Archive Plan Section Topic 4.Roles & Responsibilities Initial Track/Trace data owner; Transaction History owner; archive administrator; archive owner; technology owner; Quality (Regulatory/ Quality/Validation); management; sponsor 5.Archive Content Requirements Archive processes; data definitions; key metadata; record/data deletion; exit strategy; data migration, data retention & reporting Slide 28 GAMP Good Practice Guide: Electronic Data Archiving 2007 at www.ispe.org
  • 29 Track-and-Trace Data Archive Plan Section Topic 6.System Requirements Technology; interfaces; location/environment; security; operation; test environment; network security, interoperability with Transaction History and product verification systems 7.Compliance Requirements Risk assessment; regulatory requirements; meeting & maintaining compliance; validating transaction data collection secure storage, six year access, and reporting processes; system performance verification; change management & business continuity; SOPs; maintenance & ongoing evaluation Slide 29
  • 30 Audit of Record Creator Practices Attach meaningful descriptions to documents –At least author, date, and subject matter Record information about each document created –To ease matching electronic and related paper documents by unique IDs Backup document storage media regularly –Store one copy off site For records stored in compressed format –Keep compression software needed to restore records to original format –Ensure that later versions of compression software can still expand records stored previously Slide 30
  • 31 Audit of Record Creator Practices For records stored in encrypted format –Keep encryption software needed to restore records to original format –Ensure that later versions of encryption software can still expand records stored previously Only password protect documents when absolutely necessary –Always ensure someone else knows the password For compound documents (spreadsheets, databases and images) –All applications required to recreate the documents must be maintained Slide 31
  • 32 Audit of Record Creator Practices Check for compliance to DSCSA Title II –Section 581 (26) for Transaction History content completeness –Section 581 (27) for Transaction Statement content completeness –Section 582 (b,1,A) for six year retention Only password protect documents when absolutely necessary –Always ensure someone else knows the password For compound documents (spreadsheets, databases and images) –All applications required to recreate the documents must be maintained Slide 31
  • 33 FDA’s Metrics for Data Quality - ALCOA Attributable - data are identified with a specific subject and a specific observer or recorder. (EDC examples: password, audit trails, and e-signature) Legible - data are readable by humans. (EDC: reports, tables, and listings) Contemporaneous - data are recorded at the time they are generated or observed. (EDC examples: time stamps & time-limited entry) Original - data are recorded for the first time. (EDC examples: source data and meta data) Accurate - data are correct. (EDC examples: calculations, algorithms, analyses and transmissions) Slide 32 Data Quality EDC = Electronic Data Capture
  • 34 Any Questions or Comments? Drug Track & Trace Transaction History Archive Systems Slide 33
  • 35 Thank You! Dr. Teri Stokes, Director, GXP International www. GXPInternational.com - Email: drstokes@gxpinternational.com Common Sense Computer Validation Online Compliance Training – Sept.24, 2015
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