Analytical Method Development

Apr 02, 2013
Pharmaceutical Technology
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.
Oct 02, 2012
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.
Aug 01, 2012
Pharmaceutical Technology Europe
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.
Aug 01, 2012
Pharmaceutical Technology Europe
By Pharmaceutical Technology Editors
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.
Jul 18, 2012
Equipment and Processing Report
By Pharmaceutical Technology Editors
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?
Jul 02, 2012
Pharmaceutical Technology
IQ Consortium representatives explore industry approaches for applying GMPs in early development.
Sep 02, 2011
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Might European officials reverse their position on acceptable production methods?
Jun 15, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
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.
May 18, 2011
Equipment and Processing Report
By Pharmaceutical Technology Editors
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.
May 01, 2011
Pharmaceutical Technology
The authors developed automated equipment that uses functionally closed disposables to perform cellular and ribonucleic processing.
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