Remote Audit: Planning, Managing and Execution

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 03, Seite 328 (2021))

Lapochkin O | Bachmann A | Schimming A

Remote Audit: Planning, Managing and Execution / Clinical Supply Services – Point of view of the certifying IMP QP · Lapochkin O¹, Bachmann A², Schimming A¹ · ¹Catalent Pharma Solutions GmbH, Schorndorf und Pharmaceutical Consultancy, Tübingen
Investigational Medicinal Products (IMPs) need to follow a two-step procedure for the use in clinical trials: Firstly, the Qualified Person (QP) has to certify that the requirements of Art. 13.3 of Directive 2001/20/EC [ 1 ] have been met. Annex 13 (referred to in § 13.3 of Directive 2001/20/EC) describes the elements, which have to be taken into account when evaluating IMPs with the object of releasing batches [ 2 ]. Secondly, the sponsor has to fulfil its obligations under Art. 9 of the same directive. Additionally, AMWHV (Arzneimittel- und Wirkstoffherstellungsverordnung) [ 3 ] and Annex 16 [ 4 ] have to be ...