ICH Q10 Pharmaceutical Quality System Guidance: Understanding Its Impact on Pharmaceutical Quality.

ABSTRACT: 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. 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. There was a statistically significant difference for enab

SUBMITTER: VanDuyse SA 

PROVIDER: S-EPMC8689590 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature