The Therapeutic Goods Administration (TGA) is part of the Australian Federal Government’s Department of Health and regulates the supply, import, export, manufacturing, and advertising of therapeutic goods, including medicines in Australia.
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a non-profit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance...
PCI Pharma Services (PCI) is an international contract development manufacturing organisation (CDMO) in the pharmaceutical industry, with a network of operations and facilities worldwide. PCI is equipped to support clients looking for assistance with drug product development to clinical trials and beyond. In Melbourne, PCI offers support with the...
Kalbe Farma is a leading healthcare provider in Indonesia, with extensive operations throughout the South East Asian region. Its’ subsidiary PT Kalbio Global Medika (KGM) has recently opened a new 11,000 square meter factory in Indonesia, which received a Honourable Mention for the 2017 Facility of the Year Awards from ISPE.
The TGA has published details of the 12 month graduated transition period to PIC/S Guide to GMP PE 009-13, commencing 01 January 2018. The key changes and a transition plan have been summarised in tables by chapter and appendix and are linked here for your convenience.
The TGA announced on 13 September 2017 that it will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13) as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens from 31 December 2017.
This post was first published in July 2017 and has been updated to reflect changes.
The Therapeutic Goods Administration (TGA) is part of the Australian Federal Government’s Department of Health and is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods, including medicines
A major pharmaceutical distribution organisation engaged the services of SeerPharma (Singapore) Pte Ltd to provide a review on the compliance of its core SAP-Centric solution to the GxP Computer Systems Validation (CSV) requirements of both FDA 21 CFR Part 11 and PIC/S Guide to GMP Annex 11. There were 2 phases to this project.