Manufacturers Assessment Branch

As part of its commitment to quality and performance improvement, the TGA has restructured its Senior Executive Team to include the Branch Head of the recently created Manufacturers Assessment Branch (MAB). Dr Mark Doverty is the new Assistant Secretary (Branch Head) of the MAB. He joined the TGA from NSW Health and commenced in this position on 1 August 2005.

MAB was formerly known as the Manufacturer Assessment Section (MAS), which was a unit of the TGA Office of Devices, Blood and Tissues. The role of MAB includes:

• GMP auditing and licensing of Australian manufacturers of therapeutic goods
• GMP auditing and approval of overseas manufacturers supplying therapeutic goods to Australia
• special audits to investigate problem reports and recalls of therapeutic goods
• revision of the codes of good manufacturing practice (GMP) to reflect changes in technology and overseas requirements
• verification of GMP compliance for certification for therapeutic goods to be exported.

Dr Doverty has defined the structure of the new branch to improve overall performance and governance. Within the new branch, the Chief GMP Auditor reports directly to the Branch Head. Auditor technical governance and performance management will be improved by the introduction of 'Stream Leader' positions. There will be 4 Stream Leaders who will all report directly to the Branch Head; these include 2 Stream Leader positions for 'Medicines', 1 Stream Leader for 'Medical Devices' and 1 Stream Leader for 'Blood, Tissues and Cellular Therapies'.

Each auditor will be allocated to a designated Stream Leader for line and performance management purposes, which will lead to improvements in audit consistency. One of the principal objectives of this new structure is to ensure consistent and pragmatic interpretation and application of the Code of Good Manufacturing Practice.

Further improvements, specifically in relation to enhancing governance, regulatory transparency and the interface with industry, are planned with the establishment of Manufacturing Technical Expert Reference Groups (TERGs). Industry will be a key partner in these developments.

There are plans to establish 5 MAB TERGs in the following groups:

1. Sterile medicines
2. Non-sterile medicines
3. Complementary medicines
4. Medical devices
5. Blood, tissues and cellular therapies

It is proposed that each of the five inaugural TERGs will include two GMP Auditors, product regulator(s) from other TGA branches, and 2 to 4 industry representatives. TERGs will provide advice to Dr Doverty, through the Chief GMP Auditor, about key issues relevant to interpretation and application of the Code of GMP.

The principal objectives of establishing Manufacturing TERGs are to:

• improve the regulatory interface with industry
• enhance GMP audit consistency
• collaboratively and proactively address GMP issues
• enhance transparency around GMP regulatory processes.

It is anticipated that industry representation will by-and-large come from peak associations. In early 2006 Dr Doverty will send out invitations to key stakeholders requesting TERG membership nominations to be forwarded for consideration by the TGA.