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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 21Competence and obligations of the inspectors
1.The competent authority shall ensure that the inspectors possess adequate qualifications, experience and knowledge. In particular, the inspectors shall have the following:
(a)experience and knowledge of the inspection process;
(b)the ability to make professional judgements as to the compliance with the requirements of good manufacturing practice;
(c)ability to apply the principles of quality risk management;
(d)knowledge of current technologies relevant for inspections;
(e)knowledge of the current technologies for the manufacture of the investigational medicinal products.
2.Information acquired as a result of inspections shall remain confidential.
3.The competent authorities shall ensure that inspectors receive the training necessary to maintain or improve their skills. Their training needs shall be assessed regularly by the persons appointed for that task.
4.The competent authority shall document the qualifications, training and experience of each inspector. Those records shall be kept up to date.
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