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 …

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.

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 厂房车间，同时还要承担高额的资质维护费，以及所在国派遣检察员的现场检查费用，费时费钱费力。 随着PIC/S确认国家药监局的正式申请者身份，无疑将助力解决上述问题，实现药品国际化的“最后一公里”。 PIC/S（PharmaceuticalInspectionCooperationScheme），即药品检查合作计划。 该组 …

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.

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 …

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 Annex 16. Annex 16 was a PIC/S adaptation of the European Union (EU) Annex 16, which was originally not adopted by PIC/S.

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 Co-operation Scheme that provides the pharmaceuticals GMP guidelines for industries. Mainly they provide guidelines for sterile pharmaceutical guidelines.

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 Act). There is a 3-month transition period for adoption of the new Annex 16 to allow manufacturers to review and make necessary operational changes.