Australia: TGA issues technical guidance on the interpretation of the PIC/S Guide to GMP

21-01-2019

Australia: TGA issues technical guidance on the interpretation of the PIC/S Guide to GMP

(Source: TGA 2019-01-21)

The TGA issued the guidance which is intended to clarify the interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP) in relation to the assessment, approval and qualification of suppliers of starting and packaging materials used in the manufacture of listed and complementary medicines.

This document does not cover the entire supplier qualification process and is only intended to clarify the requirements of the PIC/S Guide to GMP.

All suppliers should be approved before materials and products are used. A separate guidance document covers reduced sampling and testing, which may be considered after supplier qualification.

This guidance is for manufacturers of listed and complementary medicines manufactured according to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP).

Development of this guidance

This guidance was developed in collaboration with the complementary medicine technical working group. Technical working groups comprise TGA and industry subject matter experts and have been established to develop, consider and review GMP guidelines.

This document is provided for guidance only and has been developed on the basis of current knowledge of the subject matter. It should not be relied upon to address every aspect of the relevant legislation. Please also refer to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 for legislative requirements and the current version of the PIC/S Guide to GMP.

Contents of the process guidance

● Understanding the nature of the starting or packaging material

● Understanding the nature of the finished product

● Obtaining information on the supplier

● Obtaining information on the supply chain

● Approval of the supplier

● Authorisation of the starting or packaging material specification

● Full sampling and testing until supplier qualified

● Analysis and trending of actual test or inspection results

● Qualification of the supplier

● Introduction of reduced sampling plan and testing as applicable to qualified suppliers (Refer to guidance: Sampling and testing for listed and complementary medicines)

● Periodic Review

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