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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 7Premises and equipment
1.The manufacturer shall ensure that premises and manufacturing equipment are located, designed, constructed, adapted and maintained to suit the intended operations.
2.The manufacturer shall ensure that the premises and manufacturing equipment are laid out, designed and operated in such a way as to minimise risk of error and permit effective cleaning and maintenance in order to avoid contamination, cross contamination and any other adverse effect on the quality of the investigational medicinal product.
3.The manufacturer shall ensure that those premises and equipment to be used for manufacturing operations which are critical to the quality of the investigational medicinal products are subjected to appropriate qualification and validation.
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