Introduction For anyone involved in the manufacturing of sterile medicinal products, the recent PIC/S GMP version 17 Annex 1 guidelines are nothing short of a bible. They delineate the rigorous standards necessary to maintain product sterility. One such crucial aspect outlined in these guidelines is cleanroom monitoring. In this blog, we aim to elucidate the…
When is World Environment Day held? World Environment Day is held each year on the 5th of June. This year, World Environment Day falls on a Monday (June 5, 2023). In this blog, we will look into the significance of World Environment Day and how the pH scale can be used as a didactic means…
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…
Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management to a Quality Culture. There are several ways senior management can demonstrate their commitment to the…
‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how continuous improvement has been built into the Pharmaceutical Quality System (PQS). The term may appear in…
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