Faecal microbiota transplants are quickly gaining popularity around the world. If you have heard of FMT, chances are either you are not particularly squeamish or you have had enough time to digest the concept, pun intended. To put it mildly, FMT is used to repopulate the bacterial microenvironment in a recipient’s bowel with healthy microorganisms….
To comply with the requirements of GMP, manufacturers must ensure that any material or service providers that they use are able to meet strict quality standards. This is due to the potential impact of materials or services on the quality of a final therapeutic product. Achieving this standard requires that a number of procedures are…
Why eLearning should be part of your regulatory compliance training programs — including during a pandemic. The GMP eLearning Business Case When we consider why eLearning is a valuable addition to GMP training programs, the following concepts come to mind: accessibility, scheduling adaptability, affordability (training cost savings), and regulatory compliance reinforcement. There is no doubt…
Cell therapy tech transfer blog Despite the no-man’s land between academia and industry is a well-trod area, it is still fraught with pitfalls this is especially the case when it comes to cell therapy tech transfer. While researchers are often frustrated with the overbearing rigour and control that forms the backbone of GMP, the industry…
Glancing at headlines these days there appears to be a consistent stream of positive news breaking out all over the world about the potential therapeutic benefits of psychedelics, including a declaration from the FDA that psilocybin is a “breakthrough therapy.” Australia has also been involved in conducting some of the research and there are ongoing…
t]As many are aware, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) develops and provides standards and guidelines for the harmonisation of Good Manufacturing Practice(GMP) in the global pharmaceutical industry. Those who fall under the umbrella of participating countries, often take for granted the fact that PIC/S is the go-to for compliance (i.e. Part 1, Part 2…
Following on from the previous blog Form Design – it’s all about the white space, comes the exciting part deux: Form Use – the right way to fill in a form. There is a general misconception that data integrity failures only result from acts of deliberate fraud. … the majority of issues relate to: which…
Tax. Return. Form. That sent a shiver down your spine, didn’t it? Because it’s longwinded, boring, complicated, sometimes unintelligible, and usually frustrating. Plus, there’s that added frisson from the fear of imprisonment due to unintentional tax fraud. Form design might seem like a banal topic but I’m pretty sure that we’ve all had first-hand experience…
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