What class of building is my facility? As architects and engineers, we get asked a lot of questions about pharmaceutical facility design. A common question relates to building classification – this is a critical initial step as it has a major effect on design, by determining the minimum technical requirements for the proposed building. What…
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…
So, you’re working for an exciting brand-new start-up. It’s getting to the pointy end – you understand all your processes, but you need to have these documented and in place to control and direct your regulated activities, ready for your initial regulatory inspection. Or perhaps your business is evolving – you need to incorporate regulation-driven…
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…
Data integrity continues to be a focus during US FDA inspections. A number of warning letters issued by the FDA in 2022 highlight the importance of Data Integrity compliance. In the warning letters issued, the FDA references the FDA’s guidance on Data Integrity; “Your quality system does not adequately ensure the accuracy and integrity of…
Microlearning can boost your chances of getting an interview when changing careers. Find out how 1-day intensive GMP training / education courses & GMP eLearning courses can help you (and other job seekers) gain interviews in an unfamiliar industry. 2023 Careers: Job Seeker GMP Training Options How is anyone supposed to figure out which career…
What is the current number of medicinal cannabis prescriptions in Australia so far? In just a few years, the number of medicinal cannabis prescriptions through the Special Access Scheme B (SAS-B) has grown substantially. It still represents a small percentage of the overall Australian population who state they rely on cannabis for medicinal purposes. Only…
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…
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