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
- Equivalence of herbal extracts in complementary medicines
- Identification of herbal materials and extracts
- Use of modified unprocessed herbal materials in complementary medicines
Links to International Guidelines adopted by the TGA
- EU and ICH guidelines adopted in Australia
- European Union guidelines used by the Office of Complementary Medicines
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:
- 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.