Manufacturing

Articles

B&W Tek’s director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using handheld Raman spectrometers.

Analysis of Raw Materials

Agnes Shanley is senior editor of Pharmaceutical Technology.

TraceLink’s first Drug Supply, Safety and Traceability Report suggests that 19% of pharma companies, 11% of distributors, and 9% of dispensers still haven’t begun to address lot-level serialization requirements. Only 20% say their CMOs will be ready for the November 2017 deadline.

Speed Bumps on the Way to Lot-Level Traceability

Johan Remmelgas is associate principal scientist, manufacturability, Pharmaceutical Technology & Development, AstraZeneca R&D, Gothenburg, Sweden.

Moisture uptake during the end-to-end manufacturing process and supply chain can affect product quality. Simulation tools based on mechanistic models help define storage and handling requirements for oral solid-dosage drugs.

Predicting Moisture Uptake in Solid Dosage Packaging

The two companies have entered into an agreement to provide Suzeken with access to AmerisourceBergen’s Cubixx inventory solution.

Suzuken to Use AmerisourceBergen’s Cubixx to Enhance Drug Distribution in Japan

Advances in cloud-based IT and user interfaces make it easier to collaborate, but a strong foundation, based on knowledge of data and risk management principles, is needed first.

Extending QMS to Contract Partners

Are investigations supporting or hindering performance excellence?

Investigation Effectiveness Drives Human Performance Excellence

PDA’s first aging facilities survey suggests that post-approval changes play a major part in slowing pharmaceutical industry investment in new technology.

Is Global Regulatory Gridlock Slowing Modernization?

In InstantGMP, cloud-based IT and an approach grounded in cGMPs, brings more of the power of paperless recordkeeping to manufacturers, at a fraction of the cost.

Paperless Batch Records for the Masses

Could greater market transparency improve pharmaceutical quality and regulatory compliance?

Could Greater Transparency Improve Pharmaceutical Quality and Compliance?

Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.

Supply Chain