TGA adopts the latest PIC/S cGMP / Regulatory Updates
Coming to Adelaide and Brisbane by popular demand!
Briefing sessions
The TGA manufacturing principles have been updated. The rules have changed! As of July 2010 Australian based and exporters to Australia will have to comply with the latest PIC/S GMP published 15 January 2009.
PharmOut offers a national educational briefing sessions of current GMP developments. We have national sessions are planned for the following centres:
Adelaide
Date: 16th Sep 2009 Time: 7:30 to 9:30 Location: Adelaide - The Lion Hotel, 161 Melbourne Street, North Adelaide Cost: $50 including GST - Breakfast included
Brisbane
Date: 17th Sep 2009 Time: 7:30 to 9:30 Location: Brisbane - Chifley at Lennons, 66-76 Queen street, Brisbane Cost: $50 including GST - Breakfast included
Melbourne
These briefing sessions can be repeated on your site.
Sydney
These briefing sessions can be repeated on your site.
What's included?
Great breakfast and a briefing session which will focus on the recent TGA regulatory changes and the practical implications to the industry and your business.
The agenda is below:
8:00 to 8:30 – TGA / PIC/S regulatory update presented by Bob Tribe, ex Head of TGA GMP compliance and PIC/S chairman.
8:40 to 9:00 – General updates on the latest international regulations presented by Trevor Schoerie, MD PharmOut. FDA process validation, draft Annex 11, PIC/S
Aseptic processing guide and more on GAMP5
Click here to download booking form.
PharmOut accepts major credit cards or can invoice your company.
Regulatory changes to be discussed
Listed below are the more significant regulatory changes, the list is not exhaustive.
Australian TGA GMP changes
29th July 2009 – TGA announces changes in the manufacturing principles
This initiative by the Australian TGA updates the Australian GMP to be aligned with the other PIC/S member country expectations and the PIC/S GMP guidelines dated January 2009. Click here for more information.
International GMP changes
1st July 2009 – PIC/S Recommendation on the validation of aseptic processes
This document details the PIC/S member country expectations in regard to validating aseptic processes. Click here for more information.
29th May 2009 – FDA, TGA and EDQM establish Confidentiality Agreements
The US Food and Drug Administration (FDA), the Australian TGA and the European Directorate for the Quality of Medicines and Health Care (EDQM) have established bilateral confidentiality agreements to share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers. Click here for more information.
17th March 2009 - Update on a pilot project to collaborate on international GMP inspection activities
As an initial effort to improve international sharing of information and to facilitate more risk based approaches to inspection planning, it was proposed that a small group of interested regulators establish a pilot programme to co-ordinate inspection planning. This was based on the system currently operating in the EU where the EMEA outlines a yearly plan for centralised inspections and invites all member states to contribute to this, based on their own inspection plans. Each regulator reserves the right to perform a dedicated “own” inspection should they consider this necessary. At the moment this focuses on API manufacturers only. Click here for more information.
15th January 2009 – PIC/S update the GMP guides
These are adopted by the regulators in the 37 members countries (as of August 2009).
PE 009-8 (Intro) 2009-01-15 PIC/S GMP GUIDE (INTRODUCTION)
PE 009-8 (Part I) 2009-01-15 PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS)
PE 009-8 (Annexes) 2009-01-21 PIC/S GMP GUIDE (ANNEXES)
November 2008 - Guidance for Industry Process Validation: General Principles and Practices - DRAFT GUIDANCE
The FDA has finally issued a draft guidance on process validation, updating its 1987 document. Risk management and quality system tools and concepts form part of the FDA’s new thinking, which is in keeping with its initiative entitled “Pharmaceutical CGMPs for the 21st Century – A Risk-Based Approach”. Click here for more information.
8th April 2008 - Draft Annex 11 Computerised Systems
The European Commission published a new, draft version of Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 11, Computerised Systems. The Annex was updated in response to the increased use and complexity of computerised systems. Highlights of the new document include the addition of risk management practices, expanded requirements for purchased systems, and additional documentation requirements.
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TGA update, booking form
Click here to download booking form. $50 including GST, continental breakfast included.