Hydrogen Peroxide Vapour (HPV) or Vapour-phase Hydrogen Peroxide Systems (VHP) as it’s more commonly known, has been used for many years as a contactless method of decontaminating cleanrooms and hospitals. It has also seen use most recently in indoor public spaces of known virus or bacteria contaminated sites such as the recent outbreaks of Covid-19…
New partnership offers cost-effective paperless validation to GMP – governed organisations in Australia. PharmOut, the Asia Pacific’s leading Pharmaceutical consulting organization, has announced a strategic partnership with ValGenesis Inc, a pioneer in paperless validation software systems. Pharmaceutical, medical device and other GMP-compliant industries incur considerable costs in creating, maintaining and storing the mountain of paper-based…
The time has come for us to talk about the Data Integrity elephant in the GMP room. Despite Data Integrity being a hot topic in industry for the past 5 years, it continues to attract a lot of attention – the constant discussion generating more questions than answers, and creating confusion over what does and…
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…
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