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Abstract

According to 21 Code of Federal Regulation (CFR) Parts 210 & 211, pharmaceutical product manufacturers must establish and follow current good manufacturing practices (cGMP) to produce quality products while meeting regulatory standards. However, the rate of advancements in manufacturing science and the pharmaceutical industries increasing understanding of quality systems greatly outpaced the updates to the cGMP regulations. Regulatory authorities began to work on initiatives intended to provide the means for meeting cGMP regulation requirements with modern Pharmaceutical Quality Systems (PQS). One such initiative is the International Council for Harmonisation (ICH) “Q10 Pharmaceutical Quality Systems” guidance. This research project was performed to test the hypothesis that the ICH Q10 guidance document aided pharmaceutical manufactures and resulted in improvements to their PQS. Statistically significant differences were determined in PQS enabler implementation, suggesting ICH Q10 had a positive impact on PQS development.

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