RACI Pharmaceutical Science Group - NSW

Update to Manufacturing Principles for Medicinal Products - Code of GMP

Monday 9 November, 2009
Ryde-Eastwood Leagues Club
117 Ryedale Road
WEST RYDE NSW 2114

As announced on the TGA website 31 July 2009 and subsequently edited here, "the TGA National Manager determined new principles to be observed for manufacturers of medicinal products" http://www.tga.gov.au/manuf/mpupdate.htm.  In practice this means that TGA will adopt the Guide to Good Manufacturing Practice for Medicinal Products as issued by PIC/S in January 2009.  (The PIC/S Guide also incorporates the Guideline Good Manufacturing Practice for Active Pharmaceutical Ingredients and the TGA intends that the Manufacturing Principles will be updated over time in line with changes to the PIC/S Guide.)

"The Determination provides for a transitional period for manufacturers to make any changes to their manufacturing procedures that may be needed to comply with the updated Good Manufacturing Practice (GMP) requirements, which will become mandatory on 1 July 2010."

In conjunction with various professional therapeutic goods organisations, TGA is presenting a seminar in the major capital cities in November with the RACI Pharmaceutical Science Group (NSW) organising the Sydney meeting, details as below.  The seminar is to outline the changes of the Code from the current 2002 version and to explain the implementation timelines and implications.

This is a must attend seminar for senior management, QA, production, laboratory, computer and regulatory personnel and associated consultants in the therapeutic goods industry.

As this seminar is not in the customary RACI Pharmaceutical group format; attendance at the seminar and the following drinks and dinner are costed separately. Registration form can be downloaded here