Compounded medicines and good manufacturing practice (GMP)

Closes 18 Dec 2020

Opened 1 Oct 2020

Overview

The current guidance Compounded medicines and good manufacturing practice (GMP) was developed in relation to the PIC/S Guide to GMP for Medicinal Products PE-009-8 15 January 2009, following public consultation in 2015. This document provides guidance on the interpretation of the PIC/S Guide to GMP for manufacturers licenced by the TGA to manufacture compounded and dispensed therapeutic goods.

Following the adoption by the TGA of the PIC/S Guide to GMP PE009-14 as the Manufacturing Principles for medicinal products, this guidance document is being updated to align with contemporary expectations. The update also includes additional guidance in relation to:     

   - the product expiry of compounded medicinal products 

   - compounding of radiopharmaceutical products

   - information for manufacturers of dose administration aids (DAAs).

The TGA is seeking comments from relevant stakeholders and other interested parties on the revision of Compounded medicines and good manufacturing practice (GMP) v3.0 prior to its final publication.

Why we are consulting

The public consultation will facilitate input from all relevant stakeholders including TGA licensed manufacturers of compounded medicines, product sponsors, pharmacy & compounding professionals and relevant authorities. All comments will be reviewed during this consultation phase to ensure the guidance is clear, meaningful and fit for purpose. 

Submissions must be relevant to the proposed revision. In addition, submissions may include information on:

  • Suggested improvements
  • Whether or not you support the changes, including suggestions for alternatives
  • An assessment of how any of the changes might impact on you

Please find below in related documents the consultation draft of Compounded medicines and good manufacturing practice (GMP) v3.0, for which we are seeking consultation.

We request that responses should be submitted using the response template (excel) also available in related documents section. Follow the directions in 'How to respond' to complete your submission. 

How to respond

Audiences

  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Health professionals
  • Health staff
  • HPRG (TGA) Staff
  • Prescription medicines
  • Other

Interests

  • Hospitals