Drug shortages have been a growing worldwide issue in recent years and represent a significant negative impact on patients’ lives. As we saw during COVID-19 and now, with Russia-Ukraine war, pharmaceutical manufacturing and distribution are facing many challenges. However, the risk of unavailability or limited supply of a drug can be Read more…
The European Union has released the new (and very much anticipated) GMP Annex 1 revision after 14 years of development! The GMP Annex 1 has all the manufacturing requirements sterile drugs both made in the EU and imported products. This 2022 version presents an upgrade to 59 pages from the Read more…
Recent world events have been showing pharma companies the importance of having an effective business continuity plan (BCP). Risk management is a crucial part of the business continuity plan, but it can be a challenge for the pharma industry, given the complexity of the supply chains. One example that is Read more…
The last few years have been full of advances in the field Advanced Therapy Medicinal Products (ATMPs). And, as any products that interfere in the health and well-being of patients, it requires a Quality Risk Management System. Which brings us to this blog post: why a Digital QRM System for Read more…