Analytics

The author discusses how to manage pending pharmacopeial changes.

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

Meticulous system configuration can prevent machines from taking over.

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.

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.

Experts share insights into analytical tools and techniques.

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?

Industry experts share their insight on solid-dosage and sterile manufacturing.

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

Careful attention to detail will help to prevent valuable assets from "melting" away.

An industry roundtable on how users and makers can best assess and manage black specks.

Applying current principals to traditional factorial designs.

Uniform dose formulation is key to meeting safety study requirements.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

An understanding of the pan-coating process based on first principles can support successful scale up.

When designing stability protocols, formulation, storage, and dosing conditions must be assessed.

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

Even the slightest of errors in exponential calculations can cause the biggest of headaches.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the May 2012 edition from Koslow Scientific Company and Vaisala.

Advances in process analytical technology and in defining lots for release are key for enabling use of continuous processes in solid-dosage manufacturing.

A technical forum featuring Tim Freeman of Freeman Technology and Carl Levoguer of Malvern Instruments.

It's better to catch costly mistakes in the laboratory before they reach the accounting department.

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

The author outlines the scientific aspects of forced degradation studies that should be considered in relation to ANDA submissions.

In this technical forum, experts describe different methods of rapid microbial testing and their applications.

An analytical technique that is receiving increased attention in the pharmaceutical industry is atomic force microscopy. We interview Mark Leaper from the UK's De Montfort University to find out more about this technology.

Parametric release and real-time testing use manufacturing data to ensure that products are made according to defined standards. PharmTech talks to Boehringer Ingelheim's Heribert Hausler about these issues.

The authors provide a review of test methodology and standards, including current industry and regulatory proposals, for biological indicator growout times.

Readers share their views on bioprocessing challenges, equipment use, and outsourcing trends in our annual bioprocessing equipment and processing survey.

In Part III of a three-part article, the authors examine various degradation routes of APIs, impurities arising from interactions in formulations, metabolite impurities, various analytical methods to measure impuritie, and ways to control impurities.