Robert Gaertner, director strategy, Veeva QualityDocs Europe, looks at the way that digitisation has changed life sciences and what the future holds, including technology development and upcoming regulatory requirements
Jörg Gierds, Fette Compacting, says that training of tablet press operators will help manufacturers stay on the right side of the US Food and Drug Administration (FDA)
John Welch, Butterworth Laboratories, urges pharmaceutical manufacturers to prepare sooner rather than later for the impending changes to elemental impurities requirements
Capsugel’s Steven Facer says prioritisation of quality and regulatory compliance from the start is key to achieving long-term gains for emerging markets
What requirements need to be met by a tablet testing system to guarantee a successful product release? Is it dependable upon the testing system’s quality, speed, technology, flexibility or safety? Kraemer and Ischi explain…
Robert Harrison, pharmaceutical industry manager of COPA-DATA, explains how appropriate technologies can help, rather than hinder, essential regulatory compliance.
The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.
Testing testing: Diane Paskiet, director, scientific affairs, West Pharmaceutical Services explains how to understand risk from extractables and leachables (E&L) and the key quality considerations when designing E&L studies
