QA / QC - Articles and news items

Lab M launches MMGA pre-poured media plate

Supplier news / 29 July 2016 / Lab M Ltd

Lab M Ltd, a Neogen company, introduces its Pinnacle™ MMGA (ISO), Mineral Modified Glutamate Agar, pre-poured media plate…

Cherwell introduces new Redipor® prepared media products to support customer needs

Supplier news / 22 March 2016 / Cherwell Laboratories

New 2016 Redipor® price list available on request…

Dissolution testing in the modern world

Issue 1 2016, PAT & QbD / 29 February 2016 / Juliet Symonds and David Elder, GlaxoSmithKline

Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products . Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu of bioequivalence testing. However, can the same dissolution test have enough robustness (as per 5 ) to be used as a routine QC tool, whilst simultaneously being sensitive enough to be truly bio-predictive? This article will explore this conundrum…

Expert View: Standardisation through automation

Issue 1 2016 / 29 February 2016 / SOTAX Group

There are several sources of variability in the “inherently poor design” of compendial dissolution apparatus types. Nevertheless, dissolution testing is a QC requirement for many products, and so the industry faces the challenge of implementing and managing fleets of dissolution equipment. However, through instrument and process design and automation, managing the products, equipment, and personnel associated with routine QC testing can be streamlined…

Application Note: Morphological changes in drug compounds under the microscope

Whitepapers / 15 January 2016 / Dr. Matthias Wagner, Product Manager, Mettler Toledo

Heated crystalline pharmaceutical compounds undergo morphological changes that can be observed under a microscope. With hot-stage microscopy changes in melting points and ranges or crystallisation can be visualised for research and QC purposes in order to influence drug stability or effectiveness…

Rapidly develop drugs targeting Interleukins with new PathHunter® cell-based assays from DiscoveRx

Supplier news / 12 January 2016 / DiscoveRx

DiscoveRx Corporation announces the expansion of its PathHunter® cell-based assays portfolio with the release of PathHunter Interleukin cell-based assays…

RMMs & Environmental Monitoring: In-depth focus 2013

Issue 4 2013, Microbiology / RMMs, Supplements / 21 August 2013 / Emanuele Selvaggio (Pfizer), Chris Delaney (Noonan Services Group)

The rapid microbiological methods revolution.
Controlling contamination in the pharmaceutical industry.
Rapid Micro Methods Roundtable.

Whitepaper: Material identification using handheld spectroscopy

Whitepapers / 15 July 2013 / Katherine A. Bakeev and Robert V. Chimenti, B&W Tek

Understand the pros and cons of using correlation versus multivariate algorithms for material identification via handheld spectroscopy…

TSI Inc. interviewed at Technopharm 2013

Videos / 7 May 2013 / Andrew Johnson, European Pharmaceutical Review

Patrik Bengtsson, Regional Sales Manager, Contamination Control – EMEA, TSI Inc. speaks to Andrew Johnson at Technopharm 2013…

Hot topics in rapid methods: revisions to validation guidance and real-time environmental monitoring

Issue 6 2012, Microbiology / RMMs / 18 December 2012 / Michael J. Miller, President, Microbiology Consultants, LLC

This is the sixth and final paper in our continuing series on Rapid Microbiological Methods (RMM) that have appeared in European Pharmaceutical Review during 2012. As many of you already know, I am keen on staying on top of recent developments in the world of rapid methods, and have used my own blog (http://blog.rapidmicromethods.com) to communicate technology advances and changes to regulatory and validation practices and expectations. In my final article of the year, I am providing an overview of two very interesting topics that have sparked additional discussions within the professional community: the proposed changes to USP’s informational chapter on the validation of alternative microbiological methods and real-time environmental monitoring.

Revision to USP Chapter <1223>: Method validation is the process used to confirm that an analytical procedure employed for a specific test is reliable, reproducible and suitable for its intended purpose. All analytical methods need to be validated prior to their introduction into routine use, and this is especially true for novel technology platforms such as RMMs.

Because many RMM technologies consist of a combination of instrumentation, software, consumables and reagents, in addition to specific detection, quantitative or identification methodologies, it is important to develop a comprehensive and holistic approach to the validation process to ensure that the entire RMM system is suitable for its intended use.

Accelerating and Automated Rapid Microbial Testing

Industry news, Webinars / 17 October 2012 / Rapid Micro Biosystems

Experts in this pharma webinar demonstrate how rapid technologies, like the Growth Direct™ System can have an impact on microbial quality control and ultimately manufacturing.

Whitepaper: New Support for ISO 14644-1

Whitepapers / 1 May 2012 / HACH LANGE

Changes in ISO 14644-1 to improve confidence in quality for critical life-science applications. Tony Harrison, UK Subject Matter Expert to ISO TC209 Working Group.