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 simultaneously. Guide to Good Manufacturing Practice for Medicinal Products - …

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 based on questions and feedback received from industry stakeholders and replaces the questions and answers on GMP previously published by the TGA.

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 relationships and their fundamental importance to the production and …

2022年2月1日 · PIC/S has published the following two guidance documents for inspectors: "Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment, led by Jenny Hantzinikolas (Australia / TGA), and will enter into force on 1 …

2020年8月10日 · 立即注册 x 整理了下关于PIC/S 重要指南的目录，供大家参考，正文的话可以点击目录里面的超链接，到官网下载，大部分都是免费的。

PIC/S即 药品检查合作计划 （Pharmaceutical Inspection Co-operation Scheme，PIC/S）于1995年成立，是由各国 GMP检查机构 组成的国际合作组织。 其前身为1970年建立的 药品检查公约 （Pharmaceutical Inspection Convention，PIC）。 PIC/S旨在通过制定GMP领域的共同标准，为检查员提供培训机会来协调全球范围内的检查程序。 此外，PIC/S还致力于促进各国监管部门、区域和国际组织之间的合作和联网，从而增进相互信任程度。 PIC/S的使命为领导国际协调 …

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 revision. The revised GMP Guide (PE 009-15), with the new Annex 2A and 2B, will enter into force on …

2015年3月3日 · TGA[1] 是TherapeuticGoods Administration的简写，全称是治疗商品管理局，它是澳大利亚的治疗商品（包括药物、医疗器械、基因科技和血液制品）的监督机构。依据1989年的治疗商品法案，TGA是递属于澳大利亚政府健康和老龄部下的一个部门。

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. This paper discusses all of the changes likely to have impact on manufacturers and what procedural, equipment or systems changes may be required to comply with the new annex.

Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, helps ensure the quality of therapeutic goods. The PIC/S Guide to GMP for medicinal products applies to the manufacture of all medicines, active pharmaceutical ingredients and sunscreens, unless exempt under the Therapeutic Goods Regulations 1990.