The TGA is seeking comments 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 document was released for consultation on May 29th with responses from interested parties to be submitted by 10 July 2013.
In 2002, Australia adopted a national Code of GMP that was based entirely on PIC/S GMP in its version current at that time, which was 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, directly as a PIC/S standard rather than transposed into a national document.
PIC/S has published two versions of its GMP since: version PE 009-9 dated 1 September 2009 and version PE 009-10, dated 1 January 2013. Where version PE 009-10 is the effective version within PIC/S, version PE 009-8 is the current version in Australia.
Where version PE 009-9 only included a revision of Annex 3 (Radiopharmaceuticals), version PE 009-10 includes a revision of Chapter 4 (Documentation) in conjunction with Annex 11 (Computerised systems) to address electronic documentation systems; as well as revisions of Annexes 6 (Medicinal gases), 7 (Herbal medicines) and 13 (Investigational medicinal products).
Based on these considerations, the TGA proposes to introduce such 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 have also developed a comparison document between the 2009 and 2013 editions of the PIC/S Guide 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 will have. The 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.