PIC/S Guide to GMP for medicinal products – version 16
2024年3月1日 · The Guide is divided into two parts with 20 annexes. The annexes provide detail on specific areas of activity. For some manufacturing processes, different annexes will apply …
This guidance is for manufacturers and explains the TGA’s interpretation and expectations for compliance with specific sections of the PIC/S Guide to GMP, PE009 -14. The content is …
The basic concepts of Quality Management, Good Manufacturing Practice (GMP) and Quality Risk Management are inter-related. They are described here in order to emphasise their …
Key Updates in PIC/S GMP Guide PE 009-17: Annex 1 Revision
2024年10月1日 · As was indicated earlier, PE 009-15 remains the version of the PIC/S GMP Guide currently (June 2023) used by Australia’s Therapeutic Goods Administration (TGA) …
NMPA成为PIC/S正式申请者，国内药企准备好了吗？ - 知乎
近日， NMPA 官宣成为药品检查合作计划（PIC/S）正式申请者，我国药品制造的国际化脚步又迈出了坚实的一步。 一直以来，国内药企想要实现药品出口就难免要重新设计改造 GMP 厂房车 …
For manufacturers subject to the Therapeutic Goods Administration (TGA) in Australia, compliance with the new guide and relevant annexes becomes mandatory on July 1st 2010. …
PIC/S发布新版GMP-资料分享-蒲公英 - 制药技术的传播者 GMP理 …
2021年4月28日 · This Working Group was led by Francesco Cicirello (formerly with Australia / TGA) until May 2020 and then by Christina Meissner (Austria / AGES), who finalised the …
TGA Adopt PIC/S Guide to GMP Version 16 Impact of Annex 16 …
2024年3月14日 · In February 2022, PIC/S released version 16 of the Guide to Good Manufacturing Practice (GMP) for Medicinal Products with the revised Annex 13 and new …
PIC/S Guidelines for GMP in Pharmaceuticals : Pharmaguideline
2018年6月2日 · Learn and download latest PIC/S Guidelines for current Good Manufacturing Practices. PIC/S is The Pharmaceutical Inspection Convention and Pharmaceutical Inspection …
From 3 June 2024 the PIC/S Guide to GMP version 16 applies to the manufacture of medicines, APIs and sunscreens, unless exempt under provisions in the Therapeutic Goods Act 1989 (the …
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