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ATMPs are based on genes, cells or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest. Often referred to as ‘Personalised Medicine’. A sector of healthcare that is rapidly evolving and expanding with some unique challenges such as microbial contamination and product variability. Traditional manufacturing processes are for synthetically derived...

GAMP® 5 Second Edition is here! Since its publication, GAMP® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance, and it was time to update our guidance to...

That question was at the heart of the of ISPE’s “Expert Xchange: Regulatory Summit on ICH Q9 Revision” held 9 June 2022. Seventy-one participants from 14 countries discussed ICH Q9(R1) and received valuable insight from several members of the Expert Working Group (EWG) assembled in 2020 to lead the ICH Q9 revision process. Discussion centered on the current state of application of quality risk...

At the ISPE Europe Annual Meeting held in Madrid on 26 April 2022, Nandini Rakala, Data Scientist & Visiting Associate, Office of Pharmaceutical Quality, CDER, FDA gave a keynote presentation on FDA’s...

Winners in this category exemplify the application of novel tools and approaches to delivering projects that improved efficiencies, overcame unusual challenges, promoted effectiveness, and organized stakeholders and project team participants in ways that led to successful outcomes such as efficiency, delivery, quality, product yield, consistency, and cost of goods.

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are some favorites for your summer reading pleasure on a topic that is always important: supply chain issues.

As the world’s second largest market for pharmaceuticals and accounting for 20% of global medical device sales with double digit annual growth, the Chinese market is poised to have a significant impact on expanding patient access to innovative therapies and combination products (CPs). 1

Digital transformation is the novel use of digital technology, including instrumentation and control systems, to solve traditional problems in a transformative manner. These digital solutions enable inherently new types of innovation and creativity, rather than simply enhancing, and supporting traditional methods.

The 2022 ISPE Pharma 4.0™ and Annex 1 Conference takes place in Vienna, Austria and virtually on 7-8 December, and will offer attendees several unique perspectives, case studies and site tours. This...

FOYA Winners in the Supply Chain Category exemplify the novel application of process manufacturing techniques, innovative design concepts, new technologies, and unique solutions that exemplify the next generation of agile, flexible, efficient, and effective new and existing pharmaceutical and biotechnology facilities. This includes implementation of commercially available and custom developed...

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...