Manufacturing medicines and biologicals

Foundation

Education and training to support small and medium enterprise

9 June 2017

As part of a program of support for small to medium enterprises (SMEs), education and training topics have been identified that will help SMEs, as well as others who may not interact with us frequently or often, to understand key issues around the regulation of therapeutic goods in Australia.

Overview

The TGA inspects all medicine and blood, blood components, plasma, biologicals and haematopoietic progenitor cells manufacturing sites in Australia, as well as some sites overseas. These inspections are to determine compliance with the relevant Good Manufacturing Practice code, standards and regulations.

Please note

This educational session will not cover medical devices.

Good Manufacturing Practice (GMP) certification is how we determine that certain therapeutic goods manufactured overseas and intended for import and supply to Australia comply with the relevant GMP requirements.

GMP clearance may be issued to sponsors of a medicine or active pharmaceutical ingredient (API) that is manufactured overseas if there is acceptable evidence demonstrating that the overseas manufacturer complies with the principles of GMP.

This education and training package will cover how to apply for a GMP licence, certification or clearance, how the TGA undertakes an inspection of a manufacturing site, and help inform you of the considerations we apply when undertaking an inspection.

A TGA manufacturing licence is required for Australian manufacturers of certain therapeutic goods intended for supply in or export from Australia under the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.

Target audience

Education and training is specifically targeted to those who are new to regulatory processes in the Australian environment. You would benefit from this material if you are manufacturing or looking at manufacturing a medicine or blood, blood components, plasma, biologicals or haematopoietic progenitor cells in Australia, or are importing from overseas.

The target audience does not include medical device manufacturers.

Learning objectives

At the end of the education and training you should have a better understanding of the following:

  1. the steps and processes involved in assessing an application for a manufacturing licence for an Australian manufacturer, or GMP certification or clearance for an overseas manufacturer
  2. some of the common pitfalls/mistakes that you can avoid in submitting GMP Clearance or license applications
  3. how inspectors approach inspections
  4. common deficiencies that we find in inspections
  5. some of the key components of Good Manufacturing Practice, for example (but not limited to):
    1. supplier qualification
    2. release for supply
    3. Product Quality Reviews

Course outline

In the education and training TGA officers will walk through case studies, highlighting common mistakes that are made during applications and common deficiencies identified at inspections.

Course delivery

We recognise that a range of different methods to deliver education and training is important. Therefore, depending on interest the delivery will include a program of:

  • face-to-face workshops (including a panel of experts, along with a facilitator), expected to be of a 1/2-1 day duration
  • webinars and training slides/packages developed and made available through the SME support service page on the TGA Website
  • partnering with other peak groups and stakeholders to deliver joint training at conferences and other events and forums.

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Event details

As specific training dates and events are announced they will appear below.