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This white paper discusses the over-arching strategy for performing a successful cleaning validation, with detail on some of the key factors to consider at both the manufacturing, microbiological and analytical stages, highlighting many common pitfalls to avoid..
This article covers how the EndoZyme II assay is established, optimised and validated using the SynergyTM HTX Multi-Mode Microplate Reader with Gen5TM software...
This whitepaper explains how an Integrated Development Platform can meet the needs of both analytical development and QC...
In this application, a Principal Component Analysis (PCA) method was found to be successful in identifying the various stearates...
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation..
FDA was perhaps understating a point when it said in its April 2016 Draft Guidance: Data Integrity and Compliance with cGMP that the increasing number of data integrity-related cGMP violations identified during its inspections was ‘troubling’...
Method transfer or method scaling across different instrument platforms can be affected by both dwell volume and extra-column dispersion...
In recent years, the FDA response to companies with insufficient proof of control over their production has become more aggressive...
TGA-FTIR was used to characterize and distinguish between different polymorphs...
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient...
Using Chromeleon 7 Chromatography Data System for enhanced data integrity...
The work presented here investigates the development and application of new bioprocess analytics in accordance with the aims of QbD...
This selective detection method greatly improves the prospect of detecting nitrosamines in pharmaceutical products and medical devices that incorporate rubber or latex...
In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation...
In this application note, PerkinElmer describes how the Spectrum Two N™ FT-NIR spectrometer can be deployed using a workflow approach, suitable for a regulated environment, to overcome a range of different challenges in raw material identification...
