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Regulatory: Page 30
Traceability/Serialization
Serialization Leadership Reflects Corporate Culture
Part One of a Special Report on serialization shows how companies delegated responsibilities within their internal departments to meet serialization mandates.
March 20, 2019
Traceability/Serialization
EU FMD Compliance: CMO Adopts Network-Tenant Approach
In one month, partners delivered a fully validated Level 3 solution and six packaging lines with full aggregation.
March 15, 2019
Pharmaceuticals
Defective Packaging Causes Birth Control Recall
Four lots of Ethinyl Estradiol USP pills were recalled due to defective blisters, empty blisters, and incorrect tablet placement.
March 14, 2019
Supply Chain
Almac Group: Almac ONE
Company launches a unified clinical trial supply solution that creates a responsive end-to-end process that enhances visibility and accuracy throughout the lifecycle of a clinical study.
March 13, 2019
Supply Chain
Breakthrough Therapies Face Unique Supply Chain Challenges
Live from the PDA Annual Meeting: Speed to market is so important in reaching patients without other options, but how do you build the supply chain with moving goalposts?
March 12, 2019
Traceability/Serialization
SPECIAL REPORT: Serialization in the Rearview Mirror
With key mandated roll-out dates behind us, the pharma industry’s drive to serialize lines has moved from the plant floor to the enterprise level. New and reconfigured lines are producing serialized product, and the focus is now on moving and protecting the data and meeting key dates for the rest of the supply chain—wholesalers and pharmacies.
March 12, 2019
Traceability/Serialization
Packaging Suppliers Find Opportunity in Serialization
The ninth and final part of this Special Report shows serialization involves makers of equipment and controls, raw materials, package design firms and companies focused on packaging distribution.
March 11, 2019
Traceability/Serialization
Finding a Role in Serialization Efforts
The eighth part of this Special Report shows companies of all sizes were involved in serialization efforts, with those responsibilities delegated to individuals at varying levels within their organizations.
March 11, 2019
Traceability/Serialization
Serialization Applies to Industries Beyond Healthcare
Part Seven of a Healthcare Packaging Playbook survey shows that while serialization has its greatest role in pharma, there’s also an impact on other industries.
March 11, 2019
Traceability/Serialization
Identifying Serialization Line Sourcing Factors
Part Six of this exclusive Healthcare Packaging Serialization Survey unveils who had the ultimate buying authority for upgrading lines.
March 11, 2019
Traceability/Serialization
Serialization’s Role in Packaging Line Changes
In Part Five of this Special Report, exclusive survey results show how many packaging lines and facilities required serialization, and how many of those were in the U.S.
March 11, 2019
Traceability/Serialization
Revealing Serialization’s Global Implications
Part Four of this Special Report indicates that while survey respondents were located primarily in the U.S., serialization’s impact is worldwide.
March 11, 2019
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Top Stories
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Manufacturers who treat ISO 11607's worst-case clauses as a risk-management tool, rather than a box to check, are far better positioned to keep their packaging, and their products, performing as intended.
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Beyond the Label: Rethinking Healthcare Packaging
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