Analytics

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Iterative and multiple incremental advances in particle-characterization technology are making a difference in pharmaceutical analysis applications.

Particle Characterization is Critical for Drug Performance

Thomas A. Little is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.

Method Validation by Design to Support Formulation Development

The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.

Quality by Design for Analytical Methods: Implications for Method Validation and Transfer

The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.

GMPs for Method Validation in Early Development: An Industry Perspective (Part II)

Robert Clifford is industrial business manager at Shimadzu Scientific Instruments. rhclifford@shimadzu.com

Minako Tanaka is a scientist at Shimadzu Applications Development Center, Kyoto, Japan, minako@shimadzu.com

Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in pharmaceutical manufacturing facilities. Three different cleaning validation methods for measuring the carbon in residual samples of various pharmaceutical substances were compared.

Carbon Measurement Methods for Cleaning Validation: Comparing Direct Combustion with Rinse and Swab Sampling Methods.

We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?

Product Neutralization for Rapid Microbiological Test Methods

IQ Consortium representatives explore industry approaches for applying GMPs in early development.

Might European officials reverse their position on acceptable production methods?

Regulators Debate Methods for Producing Water for Injection

Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.

Analyzing Aggregate-Detection Methods

Recent recalls, including that of American Regent?s caffeine and sodium benzoate injection on May 5, 2011, highlight the importance of particulate inspection, and they might lead observers to ask whether current inspection methods are sufficiently effective.

Analytical Method Development