ICH guideline Q7 on good manufacturing practice – Free PDF download

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ICH Q7 expects dedicated production areas for highly sensitizing materials such as penicillins and cephalosporins because of the patient risk (e.g., anaphylactic shock to penicillin-allergic patients) from trace amounts of these compounds in other medicines [ICH Q7, 4.40].

For materials of an infectious nature or high pharmacological activity or toxicity, a risk-based approach should be used to determine appropriate containment measures, which may include validated inactivation, cleaning and/or dedicated production areas [ICH Q7, 4.41].

 

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Continue at: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q7-good-manufacturing-practice-active-pharmaceutical-ingredients-questions-answers_en.pdf

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