SeerPharma Blog listing page

The Impact of Annex 16 Adoption by PIC/S in Australia

August 07, 2023

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.

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PDA Annex 1 Workshop (Singapore) | 16-17 May 2023

March 09, 2023

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...

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SeerPharma to Present Updates to Annex 1 at PCI Open Day

February 06, 2023

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...

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PIC/S Guide to GMP Training for PT Kalbio Global Medika in Indonesia

April 27, 2018

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.

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TGA Update: Transition to PIC/S GMP Guide PE 009-13

November 28, 2017

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.

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Prepare for TGA Adoption of PIC/S Guide to GMP PE 009-13

September 25, 2017

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.

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Navigating the Pathway of TGA Enforcement of the PIC/S Guide to GMP

July 17, 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

Good Manufacturing...

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CSV Gap Assessment for Pharmaceutical Distributor

November 15, 2016

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.

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