Read, Learn, Innovate: Top Blog Posts from September 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from September 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Ensuring supply of critical medicines during the COVID-19 pandemic has been a severe challenge and tested the limits of the pharmaceutical industry. Join us virtually, along with US Federal and local country Regulators, at the 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum on September 21-23 and discover how key manufacturers and suppliers have experienced and dealt with the latest supply chain issues to sustain reliable supplies of quality medicines.
Meaningful business continuity planning is the outcome of appropriate and strategic application of risk-benefit evaluations. It is unsustainable to have a backup for every resource, activity, and component required for pharmaceutical manufacturing. Therefore, it is vital that the pharmaceutical industry prepare for business continuity in a manner that provides the greatest assurance of continued supply of critical medicines to patients.
“Resolving & Avoiding Drug Shortages and the Health Crises They Create,” a complimentary ISPE Pharma Best Practices Webinar Series webinar on 1 September, shared the story of a patient, her family, and the extreme challenges presented for the severely ill when drug shortages occur—and how one parent is fighting to end those shortages for all families. The end of this story is a happy one because it saw the birth of a nonprofit that is devoted to assisting pediatric oncology patients in securing drugs when a shortage occurs.
As we sat down to write the this blog for iSPEAK to promote the 2020 ISPE Annual Meeting & Expo we wanted to look back over what has happened in the world in the first half of 2020 and to say it has been one for the history books is an understatement, it is something that none of us have ever seen and hope we never have to experience again. We have an opportunity to turn these terrible situations into positives.
In response to the COVID-19 pandemic, several governments are considering legislation or regulatory actions that would require some or all parts of a drug product’s supply chain, e.g., Active Pharmaceutical Ingredients (APIs) and biotherapeutic drug substances, to be manufactured within their countries to ensure consistent availability to patients and reduce potential drug shortages.
There is a real advantage in opening up and confiding in someone. Being vulnerable can be a superpower, but it does not mean that you should trust everyone with everything. It also does not mean that you should always emotionally charged break downs....