Topic

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

Articles

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

Uniformity of Dosage Units, Part 1: Acceptance Value

Mary Ann Gorko is principal statistician at AstraZeneca.

Gregory Larner is a statistics manager with Pfizer Scientific and Laboratory Services in Kalamazoo, Michigan.

Niels VÃ¦ver Hartvig, PhD, is a principal specialist, at Novo Nordisk A/S, SmÃ¸rmosevej.

Stan Altan is senior director at Janssen Pharmaceutical R&D.

Mark Johnson is senior principal statistician at AbbVie’s research department.

Yilje Dong is an independent consultant at Novo Nordisk A/S.

Stacy Sherling is research scientist at Eli Lilly.

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.

Understanding Internal Release Limits

Amy Thanavaro, PhD, is a group leader scientific-Analytical Services & Development at STERIS.

Chris Edlin, PhD, is currently director of drug development and head of Pharmaceutical Sciences in Respiratory R&D for Teva Pharmaceuticals Ireland.

Dijana Hadziselimovic is a technical services laboratory specialist for the Life Sciences Division at STERIS.

Adeyinka Aina, PhD, MRSC, is an innovation fellow at the Pharmaceutical Manufacturing Technology Centre, University of Limerick.

Paul Lopolito is a technical services senior manager for the Life Sciences Division at STERIS.

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

Rethinking Cleaning Validation for API Manufacturing

Ronak Savla is scientific affairs manager at Catalent Pharma Solutions.

Claus-Michael Lehr is head of the drug delivery department at the Helmholtz-Institute for Pharmaceutical Research Saarland, SaarbrÃ¼cken, Germany.

Brigitta Loretz is a scientist at Helmholtz-Institute for Pharmaceutical Research Saarland, SaarbrÃ¼cken, Germany.

Olga Hartwig is a PhD student at the Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS), SaarbrÃ¼cken, Germany.

William Wei Lim Chin is a technical specialist, science and technology, at Catalent Pharma Solutions.

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

Oral Delivery of Macromolecular Drugs

This paper analyzes the effectiveness of histogram binning for representing particle-sizing measurements with accuracy and precision.

A Study of the Effects of Histogram Binning on the Accuracy and Precision of Particle Sizing Measurements

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

Establishing Acceptance Limits for Uniformity of Dosage Units: Part 3

Daniela Neubert is liquid chromatography analyst at OFI Technologie & Innovation GmbH in Vienna.

Nicole Steiner-ReischÃ¼tz is coordinator at OFI Technologie & Innovation GmbH in Vienna.

Michael Pyerin is head of pharma, medical devices, and hygiene at OFI Technologie & Innovation GmbH in Vienna.

Michael WashÃ¼ttl is head of packaging at OFI Technologie & Innovation GmbH in Vienna.

Michael Krainz is project manager for packaging at OFI Technologie & Innovation GmbH in Vienna.

Chrysoula Kanakaki is GC chromatography analyst at OFI Technologie & Innovation GmbH in Vienna.

Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.

Evaluating the Impact of Sterilization on Gel Formulations

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method. 

A New Method for Risk Assessment of Pharmaceutical Excipients

F. Andreas Toba is Vice President, Intact Pharma Operations, MedInstill Development.

David A. Miller is Manager, Device Performance Engineering, MedInstill Development. 

Bryan R. Campbell is a Doctor of Osteopathic Medicine at Touro University Nevada.

Debashis Sahoo is Executive Vice-President, Regulators & Key Customers, MedInstill Development.

Daniel Py is chairman and CEO, MedInstill Development.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.

Establishing Correlation Between Aerosol and Surface Microbial Populations

Ke Wang, PhD, is director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Fangfang Liu, PhD, is manager of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Fasheng Li, PhD, is director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Aili Cheng, PhD, is director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Brad Evans, PhD, is associate director of Pfizer’s department of pharmaceutical science and manufacturing statistics.

Jingnan Zhang, PhD, is manager of Pfizer’s department of pharmaceutical science and manufacturing statistics.

A new algorithm uses a statistical approach to critical process parameter assessment, allowing for faster, more consistent, and less subjective critical process parameter quantification, visualization, and documentation. 

Peer-Reviewed Research