Quality system documents

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For therapeutics to reach the clinic and the market, their development, manufacturing and testing must satisfy the requirements of regulatory or accrediting body, such as Australia’s Therapeutic Goods Administration, National Association of Testing Authorities or the US Food and Drug Administration.

These requirements are also an important pre-requisite before industry investment into a potential therapeutic. the first step to meeting these requirements is to establish a quality management system (QMS).   

Establishing and maintaining a QMS within a facility is time and resource intensive. To assist, TIA has developed a guidance document for facilities seeking to establish a QMS, and has 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. This guidance document makes reference to key documents from iQDOCs that support establishment of a QMS.

The entire iQDOCs  library is 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.

Disclaimers:

1. The Quality documents presented on this page act as an information source only.
2. TIA makes no statements, representations or warranties about the accuracy or completeness of, and you should not rely on, any information contained in this website.
3. TIA disclaims all responsibility and all liability (including, without limitation, liability in negligence) for all expenses, losses, damages and costs you might incur as a result of the information being inaccurate or incomplete in any way, and for any reason.

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