Tab. 2:

Quality assurance guidance for MPS-based assays

Component	Useful quality assurance guidance	Stakeholders responsible
MPS equipment including chips	Adhere to standard installation, operation and performance qualification (IQ, OQ, PQ) procedures. Different standards may cause irritation – need harmonization for critical parameters	MPS supplier assisted by developer
Cell culture conditions	Medium composition, growth factor ID, quality of documentation	Medium supplier assisted by developer
Cell sources	GCCP, GIVIMP, GTP, availability (avoid dependencies on single supplier), Define “fit-for-purpose” and “context-of-use” criteria for assay development, Harmonized conditions for primary cell preparation (e.g., culture medium, number of passages)	Cell supplier, e.g. cell bank assisted by developer, end user and regulators Cell supplier assisted by the developer
Organ or disease model	In-house qualification (reproducibility measures), Functionality assessment (e.g., TEER for skin models, CYP-cocktail testing)	Model supplier, end user, developer, academic labsa
Assay	(Guidance on) reference standard (if available), testing procedure (tools, dosages, endpoints), documentation, reproducibility	End user

^aAcademic labs are not covered by the term end user.