The EU has revised Chapter 1, 2, 6 and 7 of the EU GMP Guide on “Quality Systems”, “Quality Control” and “Outsourced Activities”, respectively. As the PIC/S and EU GMP Guides must remain aligned, and requirements should be equivalent, the PIC/S Secretariat has prepared a revision of the same chapters of the PIC/S GMP Guide (applicable to Australian manufacturing).

CMA therefore invites members to consider the proposed changes and identify where any revisions may be inappropriate for the complementary medicines sector, so that we may flag these with our CM technical working group in consideration of developing specific Australian guidance documentation as required.

Please send your comments to submissions@cmaustralia.org.au by Friday 31, July 2015.

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