Example: air traffic controller
Pharmaceutical Quality System Q10
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“Quality by Design”. Process Analytical Technology and ...
www.ema.europa.euQuality system ICH consensus vision on Quality: “Develop a harmonized pharmaceutical quality system applicable across the life cycle of the product emphasizing an integrated approach to risk management and science” Quality Risk Management (Q9) Pharmaceutical Development (Q8) Quality system (Q10)
Q12 Step 5 Technical and regulatory considerations for ...
www.ema.europa.eu• Pharmaceutical Quality System (PQS) and Change Management (6. ) An effective PQS as described in ICH Q10 and compliance with regional GMPs are necessary to gain full benefit from this guideline. In particular, management of manufacturing changes across the supply chain is an essential part of an effective change management system. This ...