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Consultation: Proposal for automatic adoption of new versions of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products
This consultation closed on 12 August 2013
The TGA sought 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.
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PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE 009-10, Part 1
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Part 1 - PE 009-10 - 1 January 2013 (pdf,186kb)
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Part 1 - PE 009-10 - 1 January 2013 (Microsoft Word,136kb)
PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE 009-10, Annexes
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Annexes – PE 009-10 (Annexes) – 1 January 2013 (pdf,651kb)
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products, Annexes – PE 009-10 (Annexes) – 1 January 2013 (Microsoft Word,338kb)
Comparison between the 2009 and 2013 editions of the PIC/S Guide to GMP
- Comparison between the 2009 and 2013 editions of the PIC/S Guide to GMP (pdf,709kb)
- Comparison between the 2009 and 2013 editions of the PIC/S Guide to GMP (Microsoft Word,457kb)
Document released for consultation on Wednesday, 29 May 2013.
Interested parties responded by close of business Monday, 12 August 2013.
Feedback will be released following consideration of submissions. (see 'What will happen').
About the consultation
- PIC/S GMP is the internationally harmonised GMP standard that is also used by the European Union and New Zealand, whilst other partners (Canada, USA, Singapore) have their own national GMPs that are strongly aligned with PIC/S GMP.
- Adoption of harmonised standards is crucial to maintaining the mutual equivalence of Australia and the TGA with its Mutual Recognition Agreement (MRA) partners (EU, Switzerland, Canada, Singapore) and its partners with which a Memorandum of Understanding (MoU) is effective (USA).
- Mutual equivalence arrangements like MRAs and MoUs are essential to Australian medicines manufacturers as these arrangements allow our partner regulatory agencies for Australian based exporting manufacturers to accept TGA licensing and inspection results in lieu of conducting their own GMP inspections.
- Australian sponsors also benefit from mutual equivalence arrangements as these arrangements allow the TGA to issue GMP clearance for the majority of overseas manufacturers involved in production for the Australian market, based on TGA acceptance of GMP inspection results from those partners in lieu of a TGA GMP inspection.
- Consequently, in order to maintain equivalence, the TGA adopted the PIC/S Guide in 2009 with a view to periodically updating to future revisions of PIC/S GMP in the years following their publication.
- When adopting a new version of PIC/S GMP, the TGA is required to do industry consultation. However, at the time of consultation PIC/S has already adopted that version and consequently any outcomes from an Australian consultation can no longer be considered by PIC/S unless another revision project is started.
- This issue is best addressed by introducing a 'rolling' adoption to whichever is the current version of PIC/S GMP. This means adopting version PE 009-10 now with a provision that following publication by PIC/S of any future versions of PIC/S GMP, these new revisions will automatically be adopted with a fixed transition period.
- PIC/S has indicated that following the introduction of such a 'rolling' adoption, it is willing to amend its revision processes to allow full consideration of any outcomes of Australian industry consultations before a revision is adopted.
- 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.
- 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.
- 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).
Content of submissions
Submissions may comment on any, or all, all aspects of the proposal to introduce an automatic adoption of new versions of PIC/S GMP in the Manufacturing Principles while simultaneously introducing a consultation for Australian industry prior to PIC/S adoption of any revisions to PIC/S GMP.
In addition, submissions might include:
- Suggested improvements.
- Whether or not you support the proposal. If you do not support the proposal, you may make suggestions for an alternative acceptable to you.
- An assessment of how the proposed change will affect you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.
What will happen
Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA's Internet site. Submissions will be considered before a decision is made.
All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.
For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.
In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.
Any questions relating to submissions should be directed to the Quality & Technical Manager by email to email@example.com or by telephone to 02 6221 6880.