April 1, 2015
Volume 11 Issue 4
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SUPPLY CHAIN MANAGEMENT
Susan J. Schniepp
PDA's new technical report provides a template for bio/pharma companies to follow to establish a risk-based approach to prevent drug shortages.
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Hallie Forcinio
Implementing serialization on a packaging line requires a complex integration of hardware and software and often requires that new and existing systems work together.
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Hallie Forcinio
Careful control of payload temperature not only protects product quality, but also reduces losses due to temperature excursions and ensures profitability.
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Adeline Siew
The pharmaceutical supply chain continues to be a challenge for the industry despite advances in QbD and PAT.
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REGULATION & COMPLIANCE
A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.
/ read more /
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SUPPLY CHAIN SERVICES
Recipharm has completed a serialization project in Korea for its customer, Abbott.
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UPS expands its special commodities program to more countries.
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API MARKET OUTLOOK
Agnes Shanley
Statistics suggest a strong, but highly fragmented, small-molecule API market.
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OUTSOURCING UPDATE
Eric Langer
Capacity expansions require staff expansions, and skilled, experienced staff, at all levels, are simply becoming increasingly hard to find.
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Jim J. Zhang, PhD
Small- to medium-sized companies are expected to drive near-term growth of the global biomanufacturing outsourcing market.
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CONTRACT SERVICES REPORT
As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.
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Xcellience receives approval to handle both analytical and manufacturing of DEA Scheduled products.
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The manufacture and scale up production mark a significant milestone in the commercialization route of Nanobiotix's lead product, NBTXR3.
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The investments made in analytical and process development equipment will enable Laurus Synthesis to offer chemistry services to its clients.
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Dr. Reddy's announced that it expanded its facilities to include a formulation development laboratory at its Miyapur, Hyperabad, India plant.
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FDA has concluded that Kemwell's facility, systems, and practices comply with FDA's requirements.
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Sharon Johnson, senior vice-president, global quality and regulatory affairs, will head Catalent's new drug development organization.
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Webcasts
On Demand
Pharmaceutical manufacturers need to be more proactive in monitoring supply chain partners to ensure security and quality. An expert shares best practices that will prevent liability and noncompliance, improve quality, and boost supply chain efficiency.
Sponsored by: Spectrum Chemical Mfg. Corp
On Demand
The latest revision of USP Chapter <1079>, Good Storage and Distribution Practices for Drug Products focuses on product quality through risk management. Hear an overview of these changes, best practices to follow, and how the changes apply in the context of mapping and monitoring controlled temperature products.
Sponsored by: Vaisala
more webcasts
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