Analytics

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.

A sampling of new laboratory equipment showcases streamlined operations.

Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

Industry experts discuss how advances in analytical testing tools have helped address challenges in pharmaceutical analysis.

A bathless dissolution tester from Distek operates without a water bath and associated maintenance.

Real-time alternatives to dissolution testing are required for continuous manufacturing to reach mainstream use.

The more pharma science and technology change, the more business and policy concerns stay the same.

Incorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.

Russell Madsen, president, The Williamsburg Group, and member of the Pharmaceutical Technology editorial advisory board, shares his thoughts on technology innovations and regulatory implications.

Cheaper drugs are good for consumers, but cost restrictions limit drug company incentives to modernize facilities.

The author reviews key technological expectations of EU GMP inspectors on the integrity of e-records.

The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

The past several months have seen new product releases and updates made to already available laboratory equipment.

Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used.

In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.

Phenomenex opened a new manufacturing and development facility in CA for the company’s gas chromatography columns.

This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.

Spectrum Pharmacy Products opens pharmacy institute for training in pharmaceutical compounding.

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.

Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.

Solid-phase extraction has several advantages over liquid/liquid extraction for extractables and leachables studies.

The FPB-1P5 sanitary lab mixer is the newest addition to Eirich Machines’ OptimaBlend Fluidizing Blender family of horizontal batch mixing systems.

The portable Flexible Screw Conveyor from Flexicon can be tilted and rolled to serve multiple functions.

The LogTag UTRID-16 Data Logger System from CiK Solutions GmbH includes a built-in USB connector, automatic PDF report generation, and six-level multi-alarm display.