Proposed change (if any): Suggested text is underlined To be added to line 1886: Authorised “In ATMPs samples of critical raw materials should be retained ….” This example could be misleading by understanding that a third party (different from manufacturer and administration site) that is GMP compliant could perform reconstitution activities. is not “That GMP-compliant” should be deleted.
Proposed change (if any): Suggested text is underlined To be added to line 1886: “In Authorised ATMPs samples of critical raw materials should be retained ….” This example could be misleading by understanding that a third party (different from manufacturer and administration site) that is GMP compliant could perform reconstitution activities. “That is not GMP-compliant” should be deleted.
aiat.docx