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Regulatory: Page 13

Labeling/Printing
Schreiner MediPharm to Showcase First-Opening Indication Feature
Schreiner MediPharm
The novel combination of needlestick and product protection for the company’s protective Needle-Trap solution will debut at Pharmapack Paris.
January 12, 2023
Schreiner Medi Pharm Smp Needle Trap
Materials
Pharmapack Europe 2024 to Have 2 New Dedicated Zones
Pharmapack Europe
The event will have the new zones in 2024 due to the growth of biologics, new modalities, and contract packaging.
January 10, 2023
Pharmapack 2023
Regulatory
Counting Down the Top 10 Articles of 2022 - #1: Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections
Join us as we look back at the most-read Healthcare Packaging stories of 2022. At #1, from personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.
January 4, 2023
Aseptic processing is one of the highest risk pharmaceutical operations, and thus requires a high level of control.
Materials
Counting Down the Top 10 Articles of 2022 - #7: Manage Challenges from the EU 536/2014 Clinical Trials Regulation
Join us as we look back at the most-read Healthcare Packaging stories of 2022. At #7, we cover study startup timelines, expiry labeling on primary packaging solutions, and study administration methods.
December 27, 2022
Regulation EU No 536/2014 on clinical trials brings changes that will impact study startup processes and timelines, expiry labeling on primary and secondary packaging, and study administration methods such as direct-to-patient.
Supply Chain
HDA Issues Statement on PREVENT Pandemics Act
Healthcare Distribution Alliance (HDA)
The bipartisan legislation included in omnibus bill would bolster supply chain resilience capabilities.
December 26, 2022
Hda Pic
Labeling/Printing
Mobile-based App
Kallik
The Kallik mobile-based app is used with the company’s Veraciti label and artwork management solution to maximize efficiency and productivity.
December 22, 2022
Kallik Veraciti App Update
Packaging/Filling
Quotables and By the Numbers: November 2022
Quotes and stats on clinical trial demographics, modes of transportation, the personalized medicine market, and more...
November 21, 2022
Getty Images 1038859668
Regulatory
FDA Issues Draft Guidance on Breakthrough Devices Program
FDA
The goal of the updates is to reduce existing disparities in health and healthcare in the U.S.
November 14, 2022
Fda Logo
Packaging/Filling
Aphena Pharma Solutions Completes 3-Year, $20M Tennessee Expansion
Aphena Pharma Solutions, LLC
The expansion will allow the company to grow its bottle and blister packaging capacity, making Aphena a strong strategic growth partner for generic and OTC pharmaceutical companies.
November 9, 2022
Aphena Facility
Traceability/Serialization
Graphic Packaging Introducing Advanced Pack Serialization Solution
Graphic Packaging International
The new product will help pharma companies clamp down on counterfeit healthcare products and improve patient safety.
November 2, 2022
Graphic Packaging Serialisation
Regulatory
FDA’s Proposed Change to NDC: Comments Due Nov. 22, 2022
The NDC proposal is intended to minimize the impact of “running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs.”
November 1, 2022
Proposed NDC segments and formats. Source: FDA
Traceability/Serialization
How Missing Traceability Data Might Affect Pharmacy Patients
If accurate and complete pharma traceability data isn't supplied to pharmacists, they may end up scrambling to serve the patients in front of them. Pharmacy leaders discuss how this may affect relationships with nonconforming trading partners.
October 14, 2022
HDA Traceability Seminar dispenser panel (from left): moderator Ronald Bone, HDA Consultant, Ronald N. Bone Consulting LLC; Ian Cannell, Kaiser Permanente; Lisa Schwartz, National Community Pharmacists Association; and Leon Nevers, H-E-B.
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Top Stories
Sealed sterile syringe with needle in clear plastic packaging on dark background
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.
Researcher in lab coat examining mannequin head with blue eye patches during cosmetic or skincare product testing
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Technician in hairnet and blue shirt working at industrial machinery in laboratory setting
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Worker holding tablet displaying supply room inventory dashboard with charts in front of blue storage bins
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
3D printer setup with supply bottles and industrial equipment on red platform
Package Development
Designing the Convenience of Tamper Evidence
Products
Cagic industrial sorting and processing machine with control panel and conveyor system
AI-enabled X-ray Inspection Software Platform
At PACK EXPO, Eagle launches SimulTask 6, which offers food processors advanced image analysis, real-time production monitoring, automated reporting, and task-based inspection.
Integrated Water Insoluble Matter Testing Systems
Induction Sealing Gap System
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Laboratory technician in sterile protective gear holding a clear glass vial for sample analysis
Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Pharmaceutical manufacturing assembly line with blue and white vaccine storage boxes and vials on conveyor system
Robotics/Automation
Automation Success on the Line
Healthcare professionals discussing pharmaceutical technology with medical storage equipment and digital analytics interface displayed
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Elderberry & Honey Tonic bottle surrounded by dried flowers in white bowl on grass
Package Design
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