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 - …

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 …

2024年11月4日 · It provides a summary of the changes in g ood manufacturing practice (GMP) requirements resulting from the recent replacement of the PIC /S Guide to GMP for Medicinal Products (PE 009-15, 1 May 2021) with PE 009-16, 1 February 2022.

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 …

2019年5月17日 · PIC/S GMP指南包含基本GMP指南（第一部分）与原料药GMP指南（第二部分），连同附件涵盖无菌药品、起始物料与包装材料的取样、加压定量吸入气雾剂、液体制剂、软膏剂和油膏剂、计算机化系统放射性药品等领域，也涉及生物制品、草药、药用气体、电离辐照的使用、临床试验用药品、源于人血或全血的药品、确认与验证、参数放行、对照样品与留样等。 GMP指导文件通常是在PIC/S研讨会结束时启动，成立PIC/S工作组，由作者准备草，征求工 …

PIC/S is the abbreviation and logo used to describe both the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) operating together in parallel.

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 …

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) when inspecting manufacturers of medicines, active pharmaceutical ingredients (APIs), and sunscreens.

立即注册 x 2018年1月1日起，澳大利亚药品局（TGA）将强制实施新版GMP，即PIC/S GMP PE009-13。 药品生产企业和API（原料药用活性成分）生产企业均应遵守执行。 尽管TGA要求PIC/S GMP PE009-13指南于2018年1月1日起强制实施，但并未要求所有生产企业即刻完全满足新要求，在现场检查期间分阶段进行评估。 为配合PIC/S GMP PE009-13的实施，TGA发布了以下文件： 1.关于指南主要修订内容、12个月过渡期安排以及缺陷分类的通知。 PIC/S GMP 指南 …

Therapeutic Goods Administration PE009, the PIC/S guide to GMP for medicinal products: TGA interpretation and expectations for demonstrating compliance V2.1 September 2020 Page 10 of 69 Further questions If you have questions, or you require further clarification of a particular requirement, you can email your questions to the