PIC/S 发布修订版资格确认与验证建议 PI 006-4，取代 PI 006-3
Revision of PIC/S Recommendations on Qualification and Validation (PI 006-4)
PIC/S 已发布修订版资格确认与验证建议 PI 006-4，取代此前的 PI 006-3。该文件由 PIC/S 专门工作组修订，工作组先后由 Norman Gray（英国 MHRA）担任主席，随后由 Kevin O'Donnell（爱尔兰 HPRA）和 Rebecca Dowd（美国 FDA）共同担任主席。PI 006-4 将于 2026 年 10 月 1 日生效。
材料说明 PI 006-4 取代 PI 006-3 并给出生效日期，便于读者核对版本交替与适用时点。
Geneva, 30 July 2026 PIC/S has published the revised PIC/S Recommendations on Qualification and Validation (PI 006-4). These Recommendations have been revised by a dedicated PIC/S Working Group, successively chaired by Norman Gray (UK / MHRA) and subsequently jointly chaired by Kevin O’Donnell (Ireland / HPRA) and Rebecca Dowd (USA / US FDA). They supersede the PIC/S Recommendations on Validation Master Plan; Installation and Operational Qualification; Non-Sterile Process Validation; and Cleaning Validation (PI 006-3). PI 006-4 will enter into force on 1 October 2026. To download the revised Recommendations document, please consult the page “Publications”.
来源：PIC/S 官方 GMP 动态与指南 · picscheme.org