One of the potential pitfalls when preparing a product launch is planning for GMP inspections. An upside of recent events, is worksharing, leading towards a more globalised market. In this article Vikash Patel, ELC Group tells us more...
In this article, Katharina Paulsen, Ines Ruff, Dirk Leister, Jennifer Ramirez and Robert Heintz from Thermo Fisher Scientific, describe a co-extrusion technique and how Raman imaging microscopy was used to analyse the extruded material.
Jamie Clayton, operations director at Freeman Technology, explains how comprehensive, process relevant characterisation of wet granules can lead to control of tablet CQAs and assist design space definition in the manufacture of an OTC medicine.
Robert Gaertner, director of strategy for quality at Veeva Systems in Europe, reveals the top five reasons why quality management should be moved to the cloud.
In the second part of the CPhI Worldwide Annual Report it has been revealed that the trend towards the increased use of modern manufacturing processes and quality systems is occurring very slowly and the current drugs pipeline is discouraging.
In this online exclusive, Stuart Ward, head of Business Analysis at R&D software provider, IDBS, looks at some of the important aspects of laboratory automation that need to be considered to maintain regulatory compliance.
The US Food and Drug Administration (FDA) has issued a warning letter to Meridian Medical Technologies, concerning the manufacture of epinephrine auto injectors.
Speed to market is a significant concern in tablet manufacturing, however, moving too quickly may cause problems. Here, Dr Charles Kettler and Robert Sedlock reveal anticipatory experiments to help make the transition from R&D to full scale smooth.
In this article, the benefits and issues surrounding through-container ID verification are examined and whether testing of incoming goods can save more money in raw materials ID testing.
Doug Millington-Smith, principal applications specialist at powder characterisation company Freeman Technology, considers the value of multivariate powder characterisation as a solution to the demand for comprehensive data.
Quality and safety are in focus as industry advancements force a change, writes chief pharma expert at Bosch Packaging Technology, Johannes Rauschnable, PhD.
Dr Sade Mokuolu, group compliance manager, Watson-Marlow Fluid Technology Group, examines the importance of risk assessment in qualifying SU components to ensure global adoption continues at an accelerated pace.
