ICH Q10 PHARMACEUTICAL QUALITY SYSTEM GUIDANCE: UNDERSTANDING ITS IMPACT ON PHARMACEUTICAL QUALITY

PURPOSE: The International Council for Harmonization (ICH) “Q10 Pharmaceutical Quality Systems” (ICH Q10) guidance was introduced to address the growing gap between current good manufacturing practices and pharmaceutical manufacturing quality systems. This study evaluated the impact of the ICH Q10 guidance on the PQS of pharmaceutical manufacturers. MATERIALS AND METHODS: Data were obtained from the enabler questionnaire from pharmaceutical manufacturers surveyed by the St. Gallen OPEX Benchmarking Program. These results represent the degree of implementation for enabler-focused questions based on a 5-point Likert scale self-assessment. Data analysis included a comparison of means and medians before and after the release of the ICH Q10 guidance and annual changes. RESULTS AND DISCUSSION: There was a statistically significant difference for enabler implementation as a whole (p-value < 0.0000), before and after the release of ICH Q10 Furthermore, statistically significant differences were observed for four of the five enabler categories (p-values