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Commission Delegated Regulation (EU) 2017/1569Show full title
Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance)
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Article 5Pharmaceutical quality system
1.The manufacturer shall establish, implement and maintain effective organised arrangements to ensure that the investigational medicinal products are of the quality required for their intended use. Those arrangements shall include the establishment of a good manufacturing practice and a quality control.
2.Senior management and personnel from different departments shall participate in the establishment of the pharmaceutical quality system.
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