SERIALIZATION AT CMOS AND CPOS

1 An Adept Packaging White Paper

SERIALIZATION

READINESS

AT CMOs AND CPOs End-to-End Supply Chain Readiness

An Adept Packaging Whitepaper

SERIALIZATION AT CMOS AND CPOS

1 An Adept Packaging White Paper

Are your Contract Manufacturer Organizations (CMOs) or Contract Packager Organizations (CPOs) ready for Serialization? This white paper addresses:

I. Upcoming Serialization deadlines

II. Challenges & considerations for CMO and CPO partnerships

III. Benefits of using a standardized approach to manage Serialization at CMOs and CPOs

I. UPCOMING SERIALIZATION DEADLINES

The two most impactful deadlines are defined by the Drug Security and Quality Act (DQSA) and the EU Falsified Medicine Directive, and are rapidly approaching in 2017 and 2019 respectively. A number of additional regulations have already been enacted in countries such as:

Turkey

South Korea China

In addition, a set of new directives encom-

passing Middle Eastern countries are

expected to be released in the near future.

SERIALIZATION

READINESS

AT CMOs AND

CPOs

SERIALIZATION AT CMOS AND CPOS

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II. CHALLENGES AND CONSIDERATIONS

FOR CMO/CPO PARTNERSHIPS

A pharmaceutical company will be compliant only when all its products

including those packaged at CMOs and CPOs are serialized by the

regulatory deadlines.

Outsourcing of packaging is a growing trend and it is not unusual for

pharmaceutical companies to outsource 20% or more of their packaging

volume and up to 100% in the case of virtual companies.

Furthermore, pharmaceutical supply chain is typically global, fragmented

and complex, incorporating internal manufacturing and CMOs/CPOs.

Each step of the supply chain is affected by Serialization and must be

altered to accommodate a serialized state.

Companies need to examine their CMO/CPO partnerships in order to:

Determine the readiness of CMOs and CPOs for Serialization

Evaluate CMO/CPO selection criteria for Serialization requirements

Assess risk exposure to CMO/CPO non-compliance

This dependence of pharmaceutical companies on the readiness of CMOs

and CPOs presents a substantial compliance risk exposure.

Readiness of CMOs and CPOs for Serialization

Enabling Serialization at CMOs and CPOs demands dedicated focus.

A frequent pitfall pharmaceutical companies make is to under-estimate the time required to prepare for the enablement of both the Serialization processes on the packaging line and the data exchange of serialized information.

The window for timely compliance is closing. Pharmaceutical comp- anies shipping products to the US market that don’t currently have a precise plan of action for each of their CMOs and CPOs are dangerously late.

CMO/CPO Plan of

Action should

include:

Documented requirements

Defined timeline

Clear milestones

Agreed go live dates

“Pharmaceutical supply

chains are frequently

global, fragmented and

complex. Each step in

the supply chain is

affected by Serialization

and must be altered to

accommodate a

serialized state.”

Estimated time for line serialization and

IT integration

8 MONTHS

SERIALIZATION AT CMOS AND CPOS

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Evaluate CMO/CPO criteria for Serialization

Pharmaceutical companies can increase their likelihood of success by strategizing and standardizing their approach to CMOs. Serialization adds substantial complexity to the packaging process and requires a new set of criteria for evaluating CMOs and CPOs. Effective pharmaceutical companies reduce risk by leveraging CMOs and CPOs that are:

Already working on Serialization Demonstrate best in class IT capability Provide formal serialization programs to support their clients

.

Assess risk exposure to CMO/CPO non-compliance

Different CMOs and CPOs have differing capability and challenges, resulting in a wide range of risk profiles

with some being riskier than others.

Identifying and quantifying the risk expose at each CMO/CPO provides four important benefits:

Strategic prioritization of CMO/CPOs and product serialization rollout

High performing program management structure with efficient allocation of budget and

resources

Cross-functional alignment on risks and interdependencies

Establishment of goals and a baseline to measure progress and track completion

Assessing risk upfront can provide a pharmaceutical company a higher probability of successful and timely

completion.

CMO & CPO

Evaluation Criteria

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III. BENEFITS OF USING A STANDARDIZED APPROACH TO MANAGE

SERIALIZATION AT CMOs AND CPOs

A modular, standardized approach to Serialization at CMOs and CPOs offers a scalable option and avoids pitfalls

associated with a more ad-hoc approach. Standardization results in a practical, sustainable methodology.

The 5 step approach outlined below enables consistency and fluidity in regards to CPO/CMO serialization.

SERIALIZATION AT CMOS AND CPOS

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1. Align expectations

Companies need to drive understanding and agreement of roles and

responsibilities with their CMOs and CPOs. Additionally, they should

provide their CMOs and CPOs with a timeline, a shared project plan

with tasks and milestones and KPIs to report progress. It is also very

important to agree on the specific process exceptions that must be

addressed in the serialized supply chain.

Good planning is key to managing alignment in onboarding CMOs

and CPOs.

2. Define IT architecture for the exchange of Serialization

information

Whether the exchange of serial numbers and aggregation information

is done with a portal or via B2B, systems and software must be

installed and tested. Exception scenarios and contingencies need to

be defined and personnel should be trained on how to manage such

exceptions. CMOs and CPOs also have to select the Serialization

vendor that enables Serialization at their own site and packaging line

level.

A pharmaceutical company should consider issuing its specific IT and

data requirements and implementation guidelines for the line systems

to each CMO/CPO to reduce ambiguity.

3. Contribute to CMO and CPO success

A pharmaceutical company is only as efficient in regards to

Serialization as their weakest CMO or CPO. Therefore, a hands-off

approach predicated on the belief that Serialization is a CMOs

contract responsibility, while accurate in some cases may be

counterproductive in the long term. Frequently CMOs and CPOs,

although being contractually obligated to serialize, may not be

effective in doing so on their own.

A team based approach, with proactive engagement, guidance and

assistance from pharmaceutical companies will reduce the risk of

missing deadlines at CMOs/CPOs.

Pharmaceutical companies, CMOs and CPOs must think long-term,

as Serialization is just the beginning. The final goal is Track and

Trace, which involves a much higher level of integration with CMOs

and CPOs in terms of data exchange and process alignment.

Serialization Packaging

must do:

Serialization impact analysis for

each packaging level

Packaging requirements by

market

Labeling and artwork

specifications for serialized

products

Packaging line and User

Requirement Specifications

(URSs)

Serialization IT and data

exchange must do:

Integration process and

User Requirements

Specifications

Data flow processes with

exception handling use

cases

System testing and

validation

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4. Engage CMOs/CPOs early to influence their Serialization approach

As deadlines approach, CMOs and CPOs are getting inundated with client specific timelines, unique packaging

and IT requirements, nuances on the approach, as well as calls and meetings regarding Serialization. CMOs

and CPOs have limited resources to dedicate to the management of Serialization. Pharmaceutical companies

can ensure their products continue to remain a priority to their CMOs and CPOs benefit by staying ahead of

the curve.

The sooner companies engage their CMOs and CPOs, the higher the chance is that they can influence the

approach to Serialization and safeguard consideration given to their specific requests. Once CMOs and CPOs

are occupied with business processes and IT integration with their other customers, their ability to support a

pharmaceutical company’s unique needs reduces greatly.

Another important consideration for pharmaceutical companies is to develop a strategy for managing the

challenging situations in which the negotiating power resides with the CMO or CPO and could result in high

financial obligations, lower prioritization and readiness risk.

5. Standardize Serialization Methodology for CMOs and CPOs

When it comes to determining the correct approach to Serialization, there are several tasks that

pharmaceutical companies, CMOs and CPOs must perform to be successful. These tasks pervade through

multiple company departments such as packaging engineering, graphics, manufacturing (packaging lines),

validation, quality, IT and procurement.

A modular approach with high standardization of documents and processes, greatly improves efficiency,

reduces implementation time and risks and streamlines the replication at multiple CMOs and CPOs. A

successful deployment of this strategy requires strong program and project management, accurate and

complete planning and in-depth experience and knowledge of the issues.

Consideration should also be given to facilitating the incorporation of evolving industry’s best practice into the

standardized methodology

DESIGN SOLUTION FRAMEWORKS WITH ADEPT PACKAGING The team of engineers at Adept Packaging has managed numerous global programs to enable Serialization processes and IT integrations between pharmaceutical companies and their CMOs and CPOs. Through the support of programs representing pharmaceutical companies, as well as CMOs and CPOs, Adept has developed a clear understanding of the needs and issues of both sides. The process of enabling Serialization at multiple stakeholders is never easy; however, Adept Packaging has created a structured and winning methodology, as well as a standardized approach that is built on best practices making it easily reproducible. Pharmaceutical companies, CMOs and CPOs can easily learn Adept’s approach, manage it and apply it to their business. The critical window for successful Serialization is closing, contact Adept Packaging to learn about our effective and winning approach.

SERIALIZATION AT CMOS AND CPOS

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ADEPT PACKAGING:

Adept Packaging is a packaging engineering and consulting company providing services that cover the key technical

and business needs of our clients. We specialize in the Pharmaceutical, Food and Beverage and CPG industries in

North America and Europe.

Adept is uniquely positioned with a deep technical capability and track record of successfully providing contract

Packaging Engineers, and professional services for packaging development and serialization.

Online: www.adeptpackaging.com

Phone: +1(484)373-2504

1 An Adept Packaging White Paper

“Building a new model for our profession with new possibilities for our people & clients”