pharmaceutical serialization in brasil · effective legislation in china (2014), us (2015), brasil...

Pharmaceutical Serialization in Brasil

12 Mar 2015

1© 2015 KPMG LLP, a Delaware limited liability partnership and the U.S. member firm of the KPMG network of independent member firms affiliated with KPMG International Cooperative (”KPMG International”), a Swiss entity. All rights reserved. NDPPS 210556

Agenda

Introduction

Serialization Supply Chain Overview

Global Regulatory Snapshot

Discussion and Comparison of RDC No. 54 (Brasil Law)

Key Impact Considerations and Solution Implementation Approach

Sustainability and Value Realization: Turkey Case Study

Medical Devices

Wrap‐up, Q&A


What Is Serialization?

Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the Supply Chain

Effective legislation in China (2014), US (2015), Brasil (2016) among other recent rulings (EU, Korea, Saudi Arabia, etc.)

Serialization using GS1 standards is the industry approach to enable creation and maintenance of an ePedigree

Serialization is the identification by unique serial number of each manufactured or packaged instance of a drug.

Patient Safety Revenue Loss Prevention

Supply Chain Efficiency

Regulatory Compliance


Serialized Supply Chain

Design/redesign labels & packaging to account for 2D barcodes

Keeping product data consistent across all systems

Serialize every applicable unit (bottle, bundle, case, pallet)

Perform aggregation on the packaging lines

Manage rework of serialized units

Ship serialized units

Manufacturers

De‐aggregate/aggregate serialized packaging: pick/pack & customer order

Ship serialized units

Return/destroy serialized units

Receive serialized orders and verify electronic pedigrees

Logistics Providers / Wholesalers

Receive serialized verify pedigree

For some markets: authenticate serialized units

Dispensers

In order to be compliant with China, Korea, Brasil, US and other emerging regulations, drug manufacturers must now strategically plan and execute serialization capabilities for dozens of production and packaging lines affecting hundreds of SKUs

The main challenge is not in the item level serialization component, rather in achieving interoperable data exchange and continuity among multiple ERP systems, trading partners, and business

Packaging Distribution &Returns

Wholesalers Pharmacies &Hospitals

Product Data& Labeling


Global Regulatory Snapshot

REGULATIONS DEFINITIONSGLOBAL SERIALIZATION REGULATORY SNAPSHOT

ILLUSTRATIVE SERIALIZED PRODUCT LABELS

Pharmaceutical traceability requirements are being imposed by many country regulatory agencies in an attempt to secure the legitimate Supply Chain from infiltration of counterfeit or adulterated products

Argentina, Turkey, China, Korea, Saudi Arabia, Brasil and the US have active legislation that expands to impact wholesalers / distributors, logistics providers, hospitals and pharmacies

Current and expected regulatory mandates in over 40 markets will require that each saleable unit (“pack”) be coded with a unique serial number, which can be non‐sequential (pseudo‐randomized) to enable complete traceability

While most countries are using standards from international organizations such as ISO (www.iso.org) and GS1 (www.gs1.org) for serializing products, the effort required by all participants in the Supply Chain to cost‐effectively plan, implement, qualify, maintain and support solutions is considerable

Serialization: the marking of a unique identifier on each saleable unit of product which is associated to both the product ID and the batch/lot number

Coding: the marking of machine‐readable codes to identify product and other attributes such as the lot number, expiration date, etc.

Track: where is product now?

Trace: where has product been?

e‐Pedigree: a legally‐binding document in electronic form indicating product chain of custody (changes of ownership)

Verification: confirmation that package serial number is valid (i.e. legitimate number for item/batch; not previously dispensed, not expired, not returned, etc.)

Aggregation: electronic linkage of “child” serial numbers to a “parent” serial number (e.g. unit serial numbers linked to case serial number, case serial numbers linked to pallet serial number), which is used for efficient assignment of serial numbers to sales orders

Serialized Carton

GS1 data matrix code

China Electronic Drug Monitoring Code (EDMC)


High‐level Overview of RDC No. 54 (Brasil Law)

Scope & Status

Summary of

Regulation

Deadlines

• RDC No. 54 effective 10 Dec 2013 and applies to all products and samples under ANVISA registration

• $30B USD in drug sales ($6B generic), 5B Rx units exchanged, 30B Rx transactions each year

• Serialization: unit‐level, randomized number owned by MFG, aggregation• Supply Chain tracking: all products moving from MFG to Dispenser• Government reporting: all products and transaction events

• 10 Dec 2015: three (3) batches of serialized and aggregated units

• 10 Dec 2016: complete Track & Trace implementation for FGs made / imported after this date


Technical and Other Noteworthy Aspects of RDC No. 54

• Manufacturers must encode a two‐dimensional datamatrix, print the following minimum information:

I. ANVISA medicine registry numberII. Serial numberIII. Expiration dateIV. Batch number

• While not required by law, manufactures will likely follow GS1 standards, including by adding the Global Trade Item Number (GTIN) for global master data purposes (see presentation below)

• Serial numbers must be 13 digits in length, randomized and not repeated across a Legal Entity

• Phase I can be the same SKU, but how to track / report?; bridging stock is confirmed as acceptable

• Manufacturers must track each unit from batch release to Dispenser (or thru administration?)

• Tracking starts upon QA release – can be imported as WIP without being serialized

• Raw materials, product returns are not in scope, but samples are

• Information must be maintained at least one (1) year after product expiration

• Set of questions posed to ANVISA – limited response, expect lack of clarification (solution is industry‐led)

IUM : Identificador Único de Medicamento


Comparison of RDC No. 54 to Global Track & Trace Regulations

Opportunities

Threats

Global Operators

Phased Approach

Standards

Serialization Experience

Technical Requirements

Fragmented Operations

MFG Traceability Ownership

Serialization Experience

Supply Chain Investment Decisions

Manufacturers (and the entire Supply Chain) must act immediately to begin planning for Serialization implementation and

impact.

Adherence is not only compliance, but a business decision that may affect future profitability!


Key Impact Considerations of Serialization

Market Health Authorities

ContractManufacturing

Wholesalers / Dispensers

Vendors / Solution

Providers

Packaging Line Execution

3rd Party Logistics

Budget Scope Schedule Quality

Risk Areas: X X X

Risk Areas: X X X X

Risk Areas: X X X

Risk Areas: X X X

Risk Areas: X X X X

Risk Areas: X X X X

Regulations are country-specific and in some cases unknown / pending. Typically the primary driver for a T&T implementation strategy. Manufacturers should focus on the right solution architecture that can scale and adopt over time.

CMOs have been slow to respond to and adopt T&T capabilities. Manufacturers must manage and align outsourced operations and ensure their products are prioritized.

Wholesalers are incentivized to be major contributors to serialization initiatives. Similarly, Dispensers have certain expectations about codification. Manufacturers should plan to engage with the major customers now.

Some solution vendors in this market are relatively new. There is a concern about their ability to effectively support.

Focus required for equipment installation and SKU transition must be balanced with other competing initiatives and product launches. It is a long and time consuming effort and manufacturers should closely monitor this workstream.

3PLs require a separate but integrated solution. Manufacturers should consider engaging with 3PLs early in the program.

Impact


Solution Implementation Approach

Stabilize environment by establishing control and balancing structure for improved maturity

Improve business efficiencies by prioritizing, executing projects (e.g. compliance initiatives)

Optimize business performance with continuous improvement initiatives and shared practices

Project Phase

Key Activities

Deliver‐ables

Project Initiation(13%)

Project Planning(33%)

Project Execution(27%)

Project Monitor & Control (20%)

Project Completion (7%)

• Confirm Business Case

• Define Program Charter

• Establish project team

• Business Case, Program Charter

• Regulatory impact study

• Milestone Plan

• Cost estimates

• Performance metrics

• Org. chart

• Stakeholder analysis

• Assess current state process and impact areas

• Establish Program Management Plan

• Prepare to launch program

• Program Management Plan

• Budget, scope and schedule

• Solution architecture

• URS / FRS

• Validation strategy

• Change Management and Communication Plans

• Vendor selection and procurement strategy

Decision Tollg

ate

• Manage program budget, scope and schedule

• Coordinate functional working sessions and global collaboration forums

• Monitor, escalate issues

• Recurring status reports and communications (project, Executives)

• Label specifications and Change Control process

• Validation Plans, SOPs

• Pilot, Training Plans

• Global workshop (design)

• Risk, issue management

Decision Tollg

ate

• Monitor program performance

• Preparation for go‐live

• Post‐live support and maintenance

• Benefits Realization Plan (ROI)

• Progress, performance reporting and metrics

• Global workshop (shared practices)

• Go‐forward sourcing strategy for SKUs

• Regulatory monitoring and Public Policy

• Risk, issue management

Decision Tollg

ate

• Manage transition to operations

• Review, close program

• Transition Plan

• Measured performance results

• Lessons learned workshop, report

• Close‐down communications

• Celebrate!

Schedule Management

Integration Management

Scope Management

People Management

Comms Management

Risk Management

Quality Management

Decision Tollg

ate

Serialization implementations require Project Management rigor that is tailored to the traceability regulations, outputs and timelines.


Sustainability and Value Realization

PRL / Labeling Workflow

Change Requests

Quick Hit Sustainability Mechanisms

Regulatory Intelligence

QA Agreements

Trade Agreements

Compliance (Stage 1) Sustainability (Stage 2) Value Realization (Stage 3)

New / revised manufacturing sites, lines and equipment

New / revised products, legislation, and business development / markets

New / revised suppliers (3PL, 3PPs, CMOs)

New / revised customers

New / revised systems and data

Global Change Control system (Global Quality)

Artwork, components(Data Management, Global Graphics)

Monitor, coordinate compliance

(Regulatory Affairs, Public Policy)

Contractual SLAs with suppliers(Procurement)

Contractual SLAs with customers (Trade)


Turkey Case Study

Turkey is considered to be a pioneer in Serialization, having implemented Track & Trace requirements since 2009.

Source: http://its.technarts.com.tr/index.php

73M people covered

250 drug manufacturers registered

24K pharmacies, 41 reimbursement companies onboard

Payback period = 18 hours


What About Medical Devices?

Unique Device Identification (UDI) SystemFinal Rule – September 2013 Sec. 519(f) of the FD&C Act

Other countries are watching the implementation of the US FDA UDI law and are expected to follow suit shortly in terms of their own legislation and requirements (hopefully aligned).

For each UDI, labeler must submit product information to US FDA Global Unique Device Identification Database (GUDID)*

Requires the label of medical devices and device package of each medical device to include a unique device identifier (UDI)

Requires that each UDI be provided in a plain‐text version and in a form that uses automatic identification and data capture (AIDC) technology

1

2

3

UDI required to be directly marked on the device itself if the device is intended to be used more than once and reprocessed before each use

Master Data Management:• US FDA GUDID Submission

Graphics & Labeling Change Control:• PPC / PLR Execution

Packaging Operations & Engineering:• Printing / Marking PI + DI

1

2

3

Workstreams

* Must use YYYY‐MM‐DD format or EVERY date present on labeling


Wrap‐up, Q&A

Other Resources

• ANVISA normative instructions

• Industry association publications

• GS1 guidance documentation

http://www.kpmg-institutes.com/institutes/healthcare-life-sciences-institute/articles/about/serialization-udi-solutions-

hcls.html?utm_source=link&utm_medium=vanity&utm_campaign=hcls-udi


For more information, questions and requests for proposals, please contact:

Leonardo Augusto GiustiHead of Life Sciences - [email protected]+ 55 11 2183-3213

pharmaceutical serialization in brasil · effective legislation in china (2014), us (2015), brasil...

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