Packaging and Distribution

The US federal Drug Quality and Security Act (DQSA) and more specifically the Drug Supply Chain Security Act (DSCSA), referring to Title II of the law, requires phase-in of requirements to prevent counterfeiting. An expert discusses how companies should be preparing to meet the requirements of the DSCSA.

Pharmaceutical manufacturers will be-and are already&mdashfacing enormous challenges to implement the serialization regulations within the given timeframe.

In the past 10 years, safety issues have become increasingly important in pharmaceutical packaging, from needle sticking safety to counterfeit protection.

Packaging Coordinators, Inc. expands its services with acquisition of Penn Pharmaceutical Services.

Modular design and quick-changeover features help deliver flexibility and maximize return on investment.

West's new plant in India will manufacture primary packaging for injectable drugs.

The MG2 Selekta is a high-speed checkweigher and sorting machine for tablet production.

The Flexi-Cap features a first-opening indication as an anticounterfeiting solution.

New packaging concepts and equipment, including systems for vial handling, printing and labeling, and parenteral packaging, were revealed at INTERPHEX 2014.

Printing, labeling, aggregation, and inspection equipment meets serialization requirements.

Garvey's vial-drying system and pressure-less accumulator reduces drying time and decreases the risk of vial damage.

MG America's ACE-BT300 Coding and Verification Unit provides track-and-trace capabilities for bottles.

The FXS Combi from Bosch Packaging Technology features an integrated capping station for vials and cartridges.

The Press Out Universal Mini from Sepha can deblister at a speed of up to 15 packs per minute.

The Manesty TPR 500 tablet press from Bosch Packaging Technology increases output and features a hygienic design.

Tony Wright, CEO of Exelsius Cold Chain Management, answers questions about the new requirements for temperature-controlled pharmaceutical distribution.

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

Displays will include new products for anticounterfeiting, labeling, and compliance packaging and new equipment for filling, aggregating, and quality control.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

Manufacturers are taking measures to comply with new package safety rules.

Using best practices for manual or automatic inspection can improve the inspection process.

Trends driving pharmaceutical packaging include product protection, productivity boosters, and patient adherence improvement.

The Intelli-Code Carton Coding and Inspection System connects to serialization data-management systems.

A combination of overt and covert features protects against counterfeiting.

Manufacturers should plan ahead when implementing a serialization project to comply with the Falsified Medicines Directive.

A packaging defect has led to Merck voluntarily recalling all lots of Liptruzet tablets in the United States.

PCI discusses the challenges and benefits of serialization in light of the new US track-and-trace legislation.

Kurt Lumden, Director, Client services at PAREXEL's Perceptive Informatics, discusses the management of investigational product temperature excursions.

USP is developing and revising distribution standards in response to changes in the global supply chain.

Standards for ferrules and cap overseals focus on explicit warnings.