Why it matters now For a long time, menopause has sat quietly in the background of working life. It was experienced individually, managed privately, and rarely acknowledged in professional settings. That silence came at a cost – not only to the individuals affected, but to organisations that lost experience, capability, and leadership potential without ever…
What is a clean room? A cleanroom (GMP cleanroom), in my mind, is a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”. This blog will attempt to explain the necessary characteristics of a regulated company clean room not producing potent…
Corrective and Preventive Action (CAPA) is a key process within a pharmaceutical quality management system. It is the process of identifying and documenting corrections and improvements to systems and processes to reduce the risk of a deviation, non-conformance or quality issue occurring or recurring (hereafter referred to as an ‘issue’). A CAPA record must include…
We are proud to say that PharmOut is now a carbon neutral practice, in doing so reaffirming our commitment as a sustainable global consultancy practice. As a means of continuous improvement, this continues to prepare us for the challenges that face us in the responsible design and operation of buildings in working to reduce carbon…
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…
FDA Citation Tracking Tool Updated I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 2011 to current months. This tool dynamically scrapes data from various live websites and databases and provides a single, secure portal which to track and trend data, or rather…
PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update splits Annex 2 into Annex 2A: Advanced Therapy Medicinal Products and Annex 2B: Biological Medicines separately: Annex 2A: Manufacture of Advanced Therapy Medicinal Products for Human Use (ATMP) harmonises with the EudraLex Volume 4…
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