Serialisation in operational life-cycle and value realisation

Arjun Guha Thakurta, Director – Operations, Life Science Consulting, gives a rundown on serialisation, elaborates on its after effects and highlights learnings for the pharma industry from other sectors which have already gone down this route

Many of the world’s largest pharma companies converged at the ISPE 2017 Pharmaceutical Serialization Workshop in May 2017 to discuss– what next? I had been invited as a Speaker by ISPE from Asia to discuss on global issues, perspectives and case studies on readiness, planning implementation and harmonisation to ensure product protection. However, soon I realised that most of the pharma majors have almost completed their serialisation implementation programme and are moving towards discussing value realisation of their investment. I remember one of the plenary speakers introduce the concept that serialisation is like your car number plate, (but, you need a lot more in order to drive).

Another eminent speaker proclaimed that since 2002 serialisation in aerospace has already been implemented. Today 1000s of serialised parts assembled into each airplane can be traced back to a database of parts to serial numbers for the airplane and reflects real-time true state across the entire lifecycle of the aircraft. Therefore, it is not incorrect to state that for serialisation, pharma industry has a leader to follow and that’s aerospace. In India, we have already witnessed this in our government’s urgency in institutionalising Aadhaar (UID) for unique identification of all citizens and further linking that unique identity with bank accounts, gas, driving license, IT returns, PAN card, GST and so on. Primarily, it helps to authenticate the identity of the owner so that all legal transactions are traceable to the owner and the transactions executed are tracked for each event. This is basically similar to achieving the “1-2-3 Confirm” rule used by pilots in an aircraft.

Serialisation after-effects

• Increasing number of stock keeping unit (SKUs) and new launches

1. Any pharma company will continue to have new launches and product transfers. Such actions requires additional master data maintenance, ensuring the target market serialisation regulations are compatible with the existing serialisation solution and any additional investments thereof.

• Decreasing OEE

1. DIN 8743, used for calculating combined efficiency of multiple sub-processes, will no longer be the basis for calculation due to the added complexity from serialisation, tamper evident packaging, aggregation and many other factors which will have the potential for an OEE drop by eight to 12 per cent.

• Decreased flexibility

1. In an effort to optimise initial investments many companies decide on having some line levels with serialisation only solution and specific lines with aggregation units. Future launches of new products and new target markets will require additional investments which may not be a part of the launch budget.

• High CAPEX and increased OPEX

1. The extensive use of IT and line level combination for data exchange and management will have significant Cost of Goods Sold (COGS) impact. Many packaging lines have evolved from machines of the late 90s or 2000s and upgraded over the year by ‘Salami tactic’ (Band-Aids) with max. OEE around 60 per cent.

• Knowledge Management

1. During the project many external factors comes in play like the equipment vendor, external contractors, SMEs who generally taper off post-implementation. The responsibility for maintaining the system passes on to the shop floor supervisors, operators, local engineering, IT etc. and rooted responsibility generally vanishes.

• Additional work routines at all levels

1. The scope of routines generally extends from a material code creation to the inclusion of serialisation relevant master data inclusion, recipe creation, artworks harmonisation etc. which extends to work routines at all levels.

• Supplier dependencies

1. Serialisation vendor dependencies for line level is seen as one of the key contributing factors for vendor blocking and increased vendor dependencies. A well-crafted service level agreement (SLA) with the vendor will go a long way in handling incidents and issues in the operational lifecycle.

• System maintenance

1. System maintenance includes Service Level Agreements and redundant strategy for plug and play changeovers, spare parts strategy, cleaning strategy of printers (TTO, TIJ print heads), dispensers etc.

Serialisation data elements US DSCSA

Serialisation data elements constitutes elements beyond the 2D Datamatrix or the GS 128 1D barcode. For US DSCSA it is important to understand Global Trade Item Number (GTIN) and National Drug Code (NDC). While the GTIN (14 digit identifier) is used to identify all types of trade items across the world, NDC (10 digit identifier) is used only to identify drugs subject to US FDA regulation in accordance with Section 510 of the FDC Act, 21 USC 360. The NDC consists of three segments which specify the drug product’s labeller, trade product and package size. Each NDC code uniquely identifies a specific drug having a particular dosage form, strength and pack size. GS1 US does not require companies to register individual GTINs with GS1 US. Regulated company has to license a GS1 Company Prefix from GS1 US and GS1 US will maintain a record of that. The FDA already requires the NDCs to be registered with the FDA. The DSCSA does not need any additional registration of the NDC beyond that already required, nor does GTINs needs to be registered with the FDA. The DSCSA does not require reporting of Transactional Information (TI) and Transactional History (TH), when ownership of the individual instances of drugs are transferred in the supply chain, and GTINs are used as part of this reporting when GS1 data sharing standards (EPCIS) are used. Standardised Numerical Identification (SNI) includes NDC and a unique serial number (upto 20 characters) generated by the manufacturer or repackager. A SGTIN can be used as an SNI per FDA SNI Guidance Section III (F) which explicitly states that the use of a serialised NDC is compatible with, and may be presented within, an SGTIN. GS1 US recommends the use of SGTIN as a best practice for meeting requirements involving the SNI. Apart from this, Global Location Number (GLN) with Application Identifier (AI) (414) are used to identify a functional entity like a hospital pharmacy or a physical location e.g. warehouse. manufacturers, wholesaler, dispenser, CMO, 3PL or contract packager, pharmacy, doctor, hospital, health facility or other dispenser should have GLN to enable construction of EPCIS event data to meet DSCSA requirements.

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Application identifiers applicable to DSCSA Requirements

EU FMD

However, for EU FMD there are quite some topics which has been succinctly explained by Dr Stefan Artlich, Director Track and Trace, Bayer at the GS1 Global Healthcare Conference in Berlin this year. Coding of multi-market packs is easy if the packs bear only one EAN code today. Germany will allow for GTIN + National Health Reimbursement Code (NHRN) the fifth data element e.g. the DE-AT packs. However, whether Spain and Portugal will allow same is still an open topic. This is primarily due to some European countries who continue to require inclusion of their national number (e.g. Germany, France, Brazil) via National Trade Identification Number (NTIN) or National Health Reimbursement Number (NHRN) using Application Identifier AI (7xx).

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If the above scenario is considered as a de-facto standard, there are countries who have introduced non-GS1 proprietary coding (e.g. China), then the additional information to the code is further complicated.

Apart from the above complexity, the EU Delegated Regulation 2016/16 sets forth requirements on master data reporting e.g.

• Product name
• Common name
• Strength
• Pharma norm
• Pack type
• Article 57 Code/ PCID
• List of ‘Designated Wholesalers’

A Master Data Guidance by EMVO (European Medicines Verification Organization), is expected very soon.

Considering the fluid global scenario for master data management, a company can consider merger of multiple data points and create their own set of data elements. Example below can serve as a guidance for the industry:

• Product Master

1. SKU #/ GTIN
2. Description
3. Market
4. Mandate
5. Strength/ Potency/ Form
6. Quantities per pack level
7. Group Code
8. Import/ Export

• Line Enablement/ Configuration

1. Packaging Line
2. Product Flow
3. Component Specs
4. Digital Printer/ Camera Specs
5. Inspection/ Reject mechanisms
6. Recipes
7. Line Class/ Format
8. Serialised vs Non-Serialised?

• Production data

1. Batch Number
2. Batch Size
3. Quantities per shipper (partial)

• Serial Number hierarchy

1. Aggregations
2. Manufacturing Date
3. Expiration Date

Serialisation data elements constitutes elements beyond the 2D Datamatrix or the GS 128 1D barcode.

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What about the data?

A third party serialisation data management provider (generally a Cloud vendor) can provide site serialisation services constituting of:

1. Master data standardisation services
2. Serial number provisioning services
3. Notification services

This site serialisation services can be integrated with the Company ERP System which consists of:

1. Integration services – Process order, notification trigger, master data, rework and connects with site servers.
2. Serialised product data manager – which centralises multiple sites data into a single event repository server.
3. Reporting services – Dynamic reporting functionality can be developed (country/ regulation specific reporting).

What do you know about the data?

1. Interconnected: Better alignment across internal supply chain
2. Quality: Now we know it is good or we are getting there
3. Saturation: Not across all markets/ manufacturing network
4. Type: Most likely focussed on compliance (need more data for good analytics)

How can you use it effectively and create true interconnectivity across the supply chain?

1. Increase accuracy/ visibility across the supply chain (work as one)
2. Reduce waste (e.g. expiring products), returns accuracy, metrics driver etc.

What else can the data captured by serialisation be used for, in your network?

1. Investigations – Harmonised data can be successfully used for investigations of product/ supply related issues.
2. Serialised network operations – visibility beyond the manufacturer’s walls to the patient.
3. Analytics – Data analytics for process improvements (digital factory) and supply chain visibility.

Flexible integrated serialisation solution

A flexible and integrated serialisation solution supports the regulated company to:

1. Support recipe driven/ class-based configuration
2. Provide common functionalities across multiple OEM solutions
3. Support reporting requirements across multiple regulatory mandates
4. Streamline master data management and administration at the site and enterprise level

Serialisation data configuration is the key factor driving operational excellence

1. Managing the master data across the supply chain

Need to establish

1. Harmonised sources
2. Establish governance and owners of data sets
3. Integrate/ Automate

Operations

1. No longer just producing physical product
2. End user change management/ embed and optimise
3. ‘Clean Data’ at the macro and micro levels

Things to consider

‘Wisdom is not a product of schooling but of a lifelong attempt to acquire it’ – Albert Einstein

I always stop short of writing a conclusion or a summary as unlike a research paper, the serialisation world is continually evolving since the last 12 years and will continue to remain fluid till 2025.

The pharma industry will continue to invest and implement serialisation technologies and its associated data management infrastructure. The advantage of a technically strong team who can centrally manage issues from various sites and make sure that the installations are working in pristine condition with regular maintenance, calibrations and data cleansings will become an important factor in the OEE improvements. It is imperative to understand what needs to be reported and what needs to be authenticated, and how, where, when? How will commissioning, decommissioning and recommissioning be done and by whom? What is the exact market demands in details and impacted SKUs? Who are your supply chain stakeholders and partners businesses? Finally, robust metrics to measure your serialisation investment is the way forward.

References:
1. Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA, Release 1.0, May 23, 2017
2. ISPE Pharmaceutical Serialization Workshop 8 – 9 May 2017, Philadelphia, PA, USA
3. GS1 Global Healthcare Conference in Berlin on 5th April 2017