Much more is required of packaging for pharmaceuticals and medical devices these days. In 2016, healthcare packaging professionals managed several emerging regulatory requirements and market demands.
Standards
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ASTM International Committee D10 on Packaging plans to update its scope to better reflect the standards it oversees.
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ASTM International’s Committee on Technical Committee Operations (COTCO) is considering a name change voted in by members of ASTM International Committee F02 “Flexible Barrier Packaging” earlier this year.
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When the U.S.
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If you are using a particular plastic packaging system for a drug already on the market, its use is most likely USP compliant under the recently finalized USP Chapter <661> Containers-Plastics.
Article
Several U.S. Pharmacopeia packaging chapters are undergoing some sort of change, reported Dwain L. Sparks, an Eli Lilly Co.
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The U.S. Pharmacopeia is asking for your help as it revises its guidance on Good Distribution Practices.
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Get ready for a pretty different ISO 11607.
Article
Healthcare product supply chains are changing. Some are getting longer, taking pharmaceuticals and medical devices further around the world to reach growing numbers of new patients in emerging markets.
Article
The United States Pharmacopeial Convention (USP) is updating several chapters related to pharmaceutical packaging, a few of which we cover here.
Article
At the two-day conference on Medical Packaging for Patient Safety and Health Care Effectiveness held in Helsinki, every speaker mentioned at least once what has become the absolute industry standard: EN ISO 11607.
Article
USP is preparing to revise its widely used method for evaluating moisture-vapor transmission rates.
In May, the U.S.
Article
The comprehensive guide emphasizes risk-based evaluation for complying with FDA cGMP regulations. ISPE, the International Society for Pharmaceutical Engineering, has released new guidance on design, construction, commissioning, a
Article
No national requirement for pharmaceutical track and trace has materialized to supersede California’s 2015 law, and Unique Device Identification has just been proposed in draft form.
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Speakers at GS1 Connect in June shared several business reasons to standardize product identification.
Much more is required of packaging for pharmaceuticals and medical devices these days. In 2016, healthcare packaging professionals managed several emerging regulatory requirements and market demands. We count down to the top trends impacting...
ASTM International Committee D10 on Packaging plans to update its scope to better reflect the standards it oversees. The change is expected to be approved at D10’s October meeting, during which the committee will also discuss some of the...
ASTM International’s Committee on Technical Committee Operations (COTCO) is considering a name change voted in by members of ASTM International Committee F02 “Flexible Barrier Packaging” earlier this year. If approved, ASTM F02 would be known as “...
When the U.S. Pharmacopeia set out to modernize Chapter <661> Containers—Plastics, now known as <661> Plastic Packaging Systems and Their Materials of Construction, users wondered how much the revised standard would impact their...
If you are using a particular plastic packaging system for a drug already on the market, its use is most likely USP compliant under the recently finalized USP Chapter <661> Containers-Plastics. But when will you need to subject that same...
Several U.S. Pharmacopeia packaging chapters are undergoing some sort of change, reported Dwain L. Sparks, an Eli Lilly Co. retiree and now a strategic advisor and expert consultant with YourEncore, to attendees at Pharmapack North America. These...
The U.S. Pharmacopeia is asking for your help as it revises its guidance on Good Distribution Practices.
In the June 23 Webcast, “USP General Chapter (GC) <1083> Good Distribution Practices—One Global Document Under Consideration,”...
Get ready for a pretty different ISO 11607.
Nick Fotis, global packaging director for Cardinal Health, tells PMP News that ISO 11607 Parts 1 and 2 have begun to go through the revision process. Fotis recently joined David Johnson...
Healthcare product supply chains are changing. Some are getting longer, taking pharmaceuticals and medical devices further around the world to reach growing numbers of new patients in emerging markets. Others are getting shorter and more immediate...
The United States Pharmacopeial Convention (USP) is updating several chapters related to pharmaceutical packaging, a few of which we cover here.
The revision of USP Chapter <661> Containers—Plastics has been "a labor of love," says...
At the two-day conference on Medical Packaging for Patient Safety and Health Care Effectiveness held in Helsinki, every speaker mentioned at least once what has become the absolute industry standard: EN ISO 11607.
...USP is preparing to revise its widely used method for evaluating moisture-vapor transmission rates.
In May, the U.S. Pharmacopeia will host a workshop, “Pharmaceutical Packaging: Moisture Permeation.” One of the main functions of the workshop will...
The comprehensive guide emphasizes risk-based evaluation for complying with FDA cGMP regulations. ISPE, the International Society for Pharmaceutical Engineering, has released new guidance on design, construction, commissioning, and qualification of...
No national requirement for pharmaceutical track and trace has materialized to supersede California’s 2015 law, and Unique Device Identification has just been proposed in draft form.
With U.S. mandates slowly emerging, pharmaceutical and...
Speakers at GS1 Connect in June shared several business reasons to standardize product identification. Health systems representatives spoke of efficiencies that standardized identification could bring in product and patient identification and...
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