History of TGA Proposal for Automatic Adoption of New Versions of the PIC/S Guide to GMP

TGA adoption of PIC/S GMP Guide for Medicinal Products

Which version of the PIC/S GMP Guide does the TGA refer to? PIC/S Version 14, PIC/S Version 15, or PIC/S Version 16?

PIC/S GMP Guide PE 009-15 (PIC/S Version 15) was published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in May 2021.
This version (Version 15) of the PIC/S GMP Guide was adopted by the TGA in August 2022, even though PIC/S PE 009-16 (Version 16) was published in February 2022.
For information, visit the TGA’s website pages on ‘Manufacturing Principles for Medicinal Products’ at the following link: TGA publications – Pharmaceutical Industry regulatory guidance pages

PIC/S GMP Guide Versions and the TGA: PIC/S Guide Adoption History (Timelines)

Recent TGA adoption of PIC/S GMP Version 15 (PE 009-15)

The TGA adopted PIC/S GMP Guide Version 15 (PE 009-15) in August 2022.
Prior to the TGA adopting PIC/S GMP Guide, Version 15 (PE 009-15) in August 2022:
- The TGA referred to the Good Manufacturing Practice (GMP) guidelines described in PIC/S GMP Version 14 (PE-009-14).
- The TGA had adopted this PIC/S Version 14 (PE 009-14) on 4 September, 2020.
Scroll down for a brief look into the history of the TGA’s approaches to adopting new versions of the PIC/S GMP Guide.

The latest PIC/S GMP version/GMP guidelines published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) are:

PIC/S GMP Guide PE 009-16.
PIC/S Version 16 was published in June 2021.
PIC/S Version 16 included, for the first time, PIC/S Annex 16 (based on the EU’s Annex 16) offering guidance on the Authorised Person & Batch Release.
For training presentations related to PIC/S GMP ANNEX 16, click here.

Resources for TGA GMP compliance:

Training courses for GMP Compliance for the Medicinal Product/Pharmaceutical Compliance industry including articles about the TGA’s adoption of PIC/S GMP Versions

Complementary medicines and TGA resources

Links to TGA guidelines for herbal materials & extracts

Links to International Guidelines adopted by the TGA

The TGA referred to the GMP guidelines in PIC/S Version 14 from September 2020 through August 2022.

Brief Review of Historical Information

TGA adoption of PIC/S Version 14 (PE 009-14) in 2020

In September 2020, The TGA adopted PIC/S Version PE009-14 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP), excluding Annexes 4, 5 and 14, as the manufacturing principles for:

medicines
active pharmaceutical ingredients
biologicals that comprise or contain live animal cells, tissues or organs

The PIC/S GMP Guide (PE oo9-14) does not apply to:

medical devices
biologicals that comprise, contain or are derived from human cells or human tissues

Historical information and consultation period re TGA adoption of PIC/S Guidelines

Historical information on TGA adoption of PIC/S GMP versions and Industry consultation (Original blog published in May 2013)

The TGA sought comments in 2013 from interested parties on the proposed automatic adoption of new versions of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S GMP), with a transition period of 6 months from the date of publication by PIC/S, in combination with an improved industry consultation process on future revisions.
The TGA proposal document, relating to automatic adoption of PIC/S GMP guides with a transition period of 6 months, was released for consultation on May 29th, 2013; with responses from interested parties to be submitted by 10 July 2013.

The early history of TGA adoption of PIC/S GMP Guidelines and Annexes

Background to TGA adoption of PIC/S GMP Versions

In 2002, Australia adopted a national Code of GMP, based entirely on PIC/S GMP in its version current at that time.
This version was PIC/S version PH 1/97 (Rev. 3) dated 15 January 2002.
In 2009, Australia adopted the version of PIC/S GMP current at that time, which was version PE 009-8, dated 15 January 2009.
The TGA adopted PE 009-8 directly, as a PIC/S standard, rather than transposing it into a national document.

2009 to 2013 changes to PIC/S GMP Version

Since the adoption of PE 009-08 by the TGA in 2009, PIC/S published two other versions not long afterwards.
Version PE 009-9 was published by PIC/S on 1 September 2009.
PIC/S Version 10 (PE 009-10) was published on 1 January 2013.

History of differences between PIC/S Version 9 and PIC/S Version 10 & TGA adoption of these GMP compliance guidelines

Where version PE 009-10 was the effective version within PIC/S at that time, version PE 009-8 was the current version in Australia.

However, PIC/S Version 10 (2013) had some significant changes and additions related to electronic systems.
Where version PE 009-9 only included a revision of Annex 3 (Radiopharmaceuticals) compared to PIC/S Version 8:
- PIC/S Version 10 (PE 009-10) included a revision of Chapter 4 (Documentation) in conjunction with Annex 11 (Computerised systems).
- This revision was necessary/intended to address electronic documentation systems.
- PIC/S Version 10 also included revisions to Annexes 6 (Medicinal gases), 7 (Herbal medicines) and 13 (Investigational medicinal products).

In 2013, the TGA proposed to introduce a ‘rolling’ automatic adoption of new versions of PIC/S GMP guidelines.

Because the later releases of PIC/S guidelines contained significant revisions or additions, based on these considerations, the TGA proposed to introduce a ‘rolling’ or automatic adoption of new versions of PIC/S GMP, with a fixed transition period after its publication date while simultaneously introducing a consultation for Australian industry prior to PIC/S adoption of any revisions to PIC/S GMP.

The TGA developed a comparison document between the 2009 and 2013 editions of the PIC/S Guides to GMP.
As well as summarising the changes, the document also contains a table that highlights the “nature of the impact” and the “estimated significance of impact” that the changes were expected to have on the industry.
That original document can be found here

As differences between subsequent versions of PIC/S GMP are usually small and industry will be made aware of any upcoming revisions during the consultation rather than after publication, a fixed transition period of 6 months after PIC/S publication is proposed.

Further information is available on the TGA website including a comparison between the 2009 and 2013 editions of the PIC/S Guide to GMP.