​iQDOCs - Quality Documents

For therapeutics to reach the clinic and then the market, their development, including manufacturing and testing, must satisfy the requirements of the relevant 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. To assist,we have established iQDOCs, a set of over 450 open-access generic quality system documents that can be downloaded by publicly funded researchers and adapted for use in establishing quality systems.

iQDOCs documents are available as zip archives of documents that each relate to a specific code of practice. Each zip archive contains an Excel spreadsheet, named for the relevant code of practice, containing a list of documents in the zip archive.

iQDOCs includes documents relevant to
the following codes of practice
  • ISO9001
  • ISO13485
  • ISO14971
  • ISO15189
  • ISO17025
  • ICH-Q10
  • PICS GMP Medicines
  • TGA cGMP Human Blood and Tissues
  • US FDA 21CFR Part 820 QSR
  • FACT