A number of additions and updates were recently published for EudraLex Volume 4 – Good Manufacturing Practice Guidelines for stakeholder consultation, including Revision of Chapter 4 Documentation and: As a technical writer, the final item is one close to my heart, documentation being the backbone of all GMP activities. Who hasn’t heard that old adage…
Available either in print or online, the Australian Government Style Manual was created by the Australia Public Service Commission and is a reference that directs technical document writers in the appropriate use of language, such as use of spelling (especially those American Z’s), grammar, punctuation and writing conventions. It is also equally useful for scientific…
The definition of technology transfer (TT) may vary depending on the type of TT. It is generally referred as bridge between academia and industry, though it may also involve transfer of knowledge within the industry. In the pharmaceutical industry, TT would very often include transfer of new product and process from development to manufacturing. It…
The therapeutics goods industry is stuffed to the gunnels with very smart people; those who know the inside and out of all the processes and procedures in their field. They are the people that you want on board to ensure a thorough and educated approach to document writing and are commonly referred to as Subject…
In this blog I would like to share my 10 tips for writing user friendly SOPs as part of your GMP Pharmaceutical Quality System. The other day I was informed by a client that no-one on their site reads procedures and the only function SOPs performed was ticking a compliance check-box. In my experience this…
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