PIC/S、交叉汚染や賦形剤、活性物質のGDP等に関するガイダンスを発表

PIC/S（医薬品査察協定及び医薬品査察共同スキーム）は、交叉汚染や賦形剤、活性物質のGDP等に関するガイダンス文書を発表し、2018年7月1日から有効となります。

• PIC/S Aide-Memoire on “Cross-Contamination in Shared Facilities” (PI 043-1).
• PIC/S Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (PI 045-1);
• PIC/S Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046-1);
• PIC/S Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1).

PIC/Sガイダンス文書はこちら
https://www.picscheme.org/en/publications?tri=all