Implementing Serialization

Transcription

1 Implementing Serialization - HowtodoitRight Harpal Singh, Director - Business Development, ACG- Inspection harpal.singh@acg-world.com

2 Contents What - Track and Trace- Global Regulation Roadmap and GS1 standard Regulation How Important Considerations for Track and Trace Implementation Solution Architecture ACG Pharmaceutical Value Chain

3

4 What Track and Trace- Global Regulation Roadmap and GS1 standard

5 TRACK AND TRACE REGULATORY ROADMAP Turkey Started 2009 India Started in 2011 Saudi Starting in 2015 USA Starting from 2015 China Starting from 2014 Europe Starting from 2017 Brazil Starting from 2015 South Korea Starting from 2015 Jordan 2017

6 SNAPSHOT OF COUNTRYWIDE REGULATIONS Country India China Saudi Arabia Jordon Brazil Europe USA Key Points Regulatory Board DGFT CFDA SFDA JFDSA ANVISA EFPIA HDMA GS1 compliance GS1 GS1 GS1 GS1 GS1 GS1 Serialisation of primary/unit level Yes Yes Yes No Yes Serialisation of secondary/case level Yes Yes Yes Yes Yes Yes Yes Serialisation of tertiary/shipper level Yes Yes No Yes Yes No Yes Aggregation/Parent Child Hierarchy No Yes No No Yes No Yes Lot level traceability No No Yes No No No Yes Randomisation of Numbers No No No No No Yes No Government Portal Availibility Yes Yes Yes No Yes Yes No Authentication Yes Yes No No Yes Yes No Key Differences 1. Serialisation of products at different packaging levels with end user authentication. 1. Only non GS1 track and trace regulation. 2. Government to provide unique numbers (EDMCs). 3. Data to be downloaded and uploaded using an application development by a Chinese company. 1. Manufacturers must 1. Primary packaging obtain a GLN to uniquely barcoding yet not identify each loation. declared. 1. Specific data requirements outlined for manufacturers and distributors. 2. Systems to provide remote access to National Health Surveillance Agency. 3. Three batches complete track and trace data to be reported to ANVISA by Dec Tamper Evident labels to be used. 2. Random numbers to be generated excluding certain confusing characters. 3. National Health Reimbursement Number (NHRN), if present, may be included in the datamatrix.

7 U.S.A. Drug Supply Chain Security Act (HR 3204) Item level Track and Trace Nov 2023 Serialization Nov 2017 Lot Level Tracing Jan 2015 Electronic Pedigree a must for item level track and trace Reporting of Serialization data along with tracing data Serialization of Products mandatory. Serialization data not reported with tracing data. Lot level tracing data to be shared in paper pp or electronic format. Tracing Data = Transaction Information + Transaction History + Transaction Statement.

8 Encoding as per GS1 Standard Application Identifier Data Content Format* 713 Anvisa Number 21 Serial Number 13 Digit AN2+X Expiration Date (YYMMDD) N2+N6 AN2+X..20 (with function character 10 Batch Number FNC ~1 ) Example: BK34BV54BGFK421FKFNG T10Batch12~1 ANVISA Random Serial No. Expiry Date Batch No. Customization to include Plant Code, Line Code and Packing Level in Serial Number The serial number should be generated by method- all randomized and nondeterministic.

9 DATAMATRIX GRADING Grading denotes the quality of the Datamatrix, because some datamatrix will be decodable by our system, but it will not decode in other systems. So to ensure this, quality of datamatrix is maintained in our system in a manner through grading Grade is the overall symbol grade as defined in ISO/IEC

10 Source:GS1 India Org

11 Source:GS1 India Org

12 Grading Report for 2D code

13 How Important Considerations for Track and Trace Implementation Solution Architecture

14 Verif-i Implementation Architecture EPCIS Plant Server Plant Server Plant Server 14

15 DGFT Guidelines HDMA Guidelines GS1 Guidelines ISO/IEC Print quality standards 21 CFR part 11 compliance Regulatory Compliance Modular database Random UID number generation Quick query transactionti Backup and restoration facilities Product Authentication (SMS & Web) Government portal support Database Manageme nt SAP Certified False Rejection Ratio (FRR) Analysis 21 CFR part 11 compliance Multiple production report formats Remote support Excellent Service support Process Support Hardware Developme nt Verif-i Software Development Network and Security Monitoring System security Domain Policies Antivirus Policies Client-server communication Network speed and bandwidth UID download Data upload Modular Hardware Multiple format support Tool less Quick format change Online/Offline systems Integration on machines Robust design Modular Software Architecture Machine Vision implementation Multiple Printer integration Datamatrix Grading Optimized queries Database update Verification

16 SAP ORACLE ERP National Health Surveillance Agency Mylan TEVA Prizer Tracelink Axway Cloud Sol. 17

17 Aggregation Flow

18 GLOBAL LEVEL INTEGRATION Architecture to accommodate Global Level Implementation EPCIS compliance to communicate with supply chain management system. SMS and Web Based authentication support. Certified SAP Partner for Track and Trace Can be integrated to other industry standard ERPs Integration with Big Pharmaceutical company databases is possible

19 False Rejection Ratio (FRR) Analysis

20 SERIALIZATION IS MORE THAN MEETING REGULATORY DEMANDS