This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry . Quality systems approach to pharmaceutical cgmp regulations guidance for industry september 2006 joint fda ema pdma pda ispe training on ich q10 pharmaceutical quality systems . The review should include a measurement of achievement of pharmaceutical quality system objectives b assessment of performance indicators that can be used to monitor the effectiveness of processes within the pharmaceutical quality system such as 1 complaint deviation capa and change management processes 2 feedback on outsourced . Guidance for industry q10 pharmaceutical quality system us department of health and human services food and drug administration center for drug evaluation and research cder. Pharmaceutical quality system processes in a visual manner d management responsibilities within the pharmaceutical quality system quality production laboratory materials facilities and
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