On December 12 and 13, 2012, the MHRA held its annual GMP Symposium. I was able to attend this event and have captured some of the major themes within this blog. December 12 – Good Manufacturing Practices Update MHRA Future Directions The UK’s MHRA has recently confirmed its short-term areas of criticality. These include: Product…
Recognising the impact of the European Union (EU) reforms from the overhaul of medical device directives (MDD) and in vitro device directives (IVD) to regulations (MDR/IVDR), Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) have proactively engaged in public consultations to align Australian medical device regulations with the new EU framework. Consultations commenced in…
In June 2011, the Australian and New Zealand Governments announced their agreement to proceed with a joint scheme for regulation of therapeutic products (that is, medicines, medical devices, biological and others) to be administered by the Australia New Zealand Therapeutic Products Agency (ANZTPA). The new Agency will replace the Australian Therapeutic Goods Administration (TGA) and…
The PIC/S meeting in Kiev discussed and agreed on changes to PE009-9 to support the harmonisation of GMP guidance documents. PIC/S code of GMP PE-009-10 was issued by PIC/S on the 11th December, and whilst this goes some way in aligning our international GMPs and specifically the EMEA code of GMP, there are still significant…
This concept paper addresses the need to update Annex 17 (Parametric release) of the EU GMP Guide. At the time the original guideline was adopted (January 2002), the main foreseen application area was sterility testing, with a particular focus on the release of terminally sterilised medicinal products. Since then, there have been significant changes in…
Pharmaceutical Cleanrooms | Cleanroom Design Flaws: 12 things that should no longer be seen in cleanrooms | Over the past few years, I have walked through many different clean rooms, both old and new, designed and built by the small operators and the blue-chip multinationals. Regretfully, a common thread I observed with a lot of…
The advertising of therapeutic goods to consumers or health professionals is administered via a co-regulatory system which is representative of all key stakeholder groups. These stakeholders include consumers, public health advisors, health care professionals, regulated industry manufacturers, and distributors, as well as the media, advertisers, and Government agencies. Advertisement regulations Advertisements for therapeutic goods are…
What makes a cleanroom a clean room? Like anything technical, how a cleanroom works is essentially basic, but wrapped up in a whole lot of jargon, standards, rules and regulations. The basic principles are actually perfectly understandable, but you have to claw your way through a lot of irrelevance, myths and misinformation to find something…
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