Experts from the clinical tech firm talk data challenges and how monitoring technology can enable sites and sponsors to better manage audit trail reviews.
The India-based CRO Veeda Clinical Research has completed a second audit by the Malaysia Regulatory Agency, following 18 US FDA inspections over the past two years.
Finding and validating an ingredient supplier can take up to 26 weeks says consultancy firm Rephine, which hopes to address the burden through an online API sourcing platform.
Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.
The auditing company, SGS, recently certified that Capsugel’s manufacturing sites in Colmar, France and Bornem, Belgium meet Good Manufacturing Practice (GMP) standards set by EXCiPACT for pharmaceutical excipients manufacturing.
NSF International has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC) as part of a way to ensure a more streamlined supplier qualification process.
The team behind the scheme that helped BASF, Seppic and Merck KGaA reduce their audit burdens expect more excipient suppliers to seek certification as an independent association.
GMP auditors need a professional qualification similar to QP status according to a group whose new training scheme is designed to create a competency benchmark.
As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.
Industry groups developing certification standards for third-party auditors of pharmaceutical excipient manufacturers say they are ready to launch the scheme next year.
