Featured in this edition of iSpeak Reading Roundup, are the top blog posts from June 2022. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

While everyone is facing new speed to market expectations, we should consider and discuss why global regulatory barriers are increasing, why science- and risk-based strategies often mean more data are required, and why regulatory approval for new technologies and new medicines seems more challenging than ever before. We can no longer afford to delay innovation, product and process...

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some of the many articles published about Pharma 4.0™. Now is a great time to catch up with Pharma 4.0™, especially with the upcoming 2022 ISPE Pharma 4.0™ and Annex 1 Conference in Vienna on 7–8 December.

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Prudence Edwards led the panel discussion to open up ISPE’s Think Tank session at the 2022 ISPE Biotechnology Conference.

Pharma 4.0™ is a new category for the Facility of the Year Awards (FOYA) program. Winners in the Pharma 4.0 category embody the Pharma 4.0 concept. This includes not only implementing at least one technological innovation, but also demonstrating the ability to change the company’s culture, processes, and people orienting them towards a 4.0 future. Significant contributions include application...

ISPE GAMP® has led the way in computerized systems best practices for more than 30 years. GAMP brought us the concept of system lifecycles and leveraged the V-model to give us a structured approach to computerized systems validation (CSV). GAMP developed and adopted the risk-based approach to CSV, enabling industry to focus validation efforts on critical systems and functionality.

For nearly a century, production of Water for Injection (WFI) was universally accepted to be distillation-based. As emphasis on costs and environmental concerns has grown, pharmacopeias around the world have focused on the quality attributes of WFI to allow for consideration of other production technologies. In 2017, the European Pharmacopoeia joined the US, Japan, and many other regulatory...

Following an unprecedented two years in which the pharmaceutical industry has faced numerous challenges posed by the global pandemic, pharmaceutical manufacturing has had to react and respond to meet the rapidly changing requirements and timelines. This has necessitated a radical rethink in how we approach pharmaceutical manufacturing and how we meet the expectations of the market and patients...

Continuous manufacturing (CM) is gaining traction in pharmaceutical manufacturing. The purpose of this post is to highlight some of the differences between small molecule Drug Substance (DS) and Drug Product (DP) continuous manufacturing (CM), which may be helpful in considering the development and execution of CM for pharmaceutical manufacturing. The following are the key differences from our...

Gaelle Saint-Louis is the Women in Pharma® (WIP) Chair of the ISPE San Diego Chapter. She began her involvement with ISPE as the Young Professional (now Emerging Leaders) Chair for the Greater Los Angeles Chapter in 2019. After relocating to San Diego, she took on a leadership role within the Chapter's Women in...

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are answers to our most frequently asked questions about publishing in PE. We welcome submissions from members and nonmembers and have a wealth of information available to help guide your journey to becoming a published PE author.

If you take care of your employees, they will take care of your customers. Once you stop treating people like functions or costs, disengaged workers begin to share their gifts and talents toward a shared future.

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from May 2022. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

Paperless Validation is a current topic of interest within the pharmaceutical industry with many companies now adopting or planning to adopt paperless solutions with the promise of improved data integrity and significant efficiency improvements to their existing paper-based validation processes.

It goes without saying that reflecting on the last few years, immense progress has been made in the biopharmaceutical industry. We have seen an industry prioritising collaboration and innovation, combined with a healthy competitive spirit, brought new technology to reality, and achieved milestones in twelve months that would previously have taken a decade.

The exponential increase in demand to manufacture therapeutics including vaccines triggered by the pandemic has stressed the supply chain for single-use products.

It would be easy to say that the pandemic has driven dramatic growth for CDMO companies, as more pharmaceutical firms seek to outsource. Really though, the trend started much earlier, with many CDMOs having put their massive expansion plans in place a year or more before the pandemic took hold.

The ISPE South Central Chapter recently hosted their Inaugural South Central Chapter Education Seminar from College Station, while live-streaming in Austin, Houston, Dallas-Fort Worth Area (DFW), and The University of Oklahoma. Each city hosted an in-person networking dinner followed by the sessions on Vaccine/Gene Therapy Manufacturing and Writing User Requirements Specifications.