For therapeutics to reach the clinic and then the market, their development, including manufacturing and testing, must satisfy the requirements of the regulatory or accrediting body (for example, Australia's Therapeutic Goods Administration, National Association of Testing Authorities or the US Food and Drug Administration). This requirement is also becoming an important pre-requisite before industry investment into a potential therapeutic.

Establishing and maintaining such accreditation within a facility is time and resource intensive, often taking over a year and many hundreds of thousands of dollars. To accelerate this process, TIA has established iQDOCs, a set of over 450 open-access generic documents that can be downloaded by publicly funded researchers and adapted for use in establishing quality systems.

iQDOCs is currently accessible at www.iqdocs.org. However, the documents are currently being repackaged into downloadable archives of documents relevant to range of codes of practice. These packages of documents will be downloadable from this page on the TIA website.

 

These codes of practice include:

  • ISO9001

  • ISO13485

  • ISO14971

  • ISO15189

  • ISO17025

  • ICH-GCP

  • ICH-Q10

  • PICS GMP Medicines

  • TGA cGMP Human Blood and Tissues

  • US FDA 21CFR Part 820 QSR

  • FACT

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