As the pharmaceutical landscape continues to evolve, this issue highlights use of AI and GAMP ® frameworks for different areas of the industry including quality and data management.

In This Issue: We dive into sustainable practices in the pharma industry and effective ways to safely implement them.

As regulatory trends and quality initiatives continue to evolve in the pharmaceutical industry, this issue examines industry rules that support continuous improvement across the product lifecycle.

The AI Paradox Cover: The increasing digitalization of the pharmaceutical and medical device industry has created novel cybersecurity challenges, particularly with the rapid advancement of artificial intelligence (AI)...

The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products, the costs associated with patient access, and readiness.

A Skill Management Framework for a Pharma 4.0™ Workforce Feature: Pharma 4.0™ is driving fundamental industry changes and requires a comprehensive approach to workforce development. This article proposes a skill...

GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical products, ultimately benefiting both companies and patients alike. In this issue, we delve into key developments in GAMP...

Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical industry, focusing on using single-use technologies (SUT...

PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry...

The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular therapeutics, has driven steady investment in facilities capable of manufacturing these therapeutics at scale. Meanwhile, the...

The commercialization of personalized medicine has ushered in demand for a new type of facility— personalized medicine facilities—which can produce thousands of small-scale batches per year. There are currently only a...

Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific region (APAC), like any large territory, encompasses a blend of well established and early-stage economies, diverse...

Stakeholders across industries are becoming accustomed to using information technology (IT) systems, applications, and business solutions that feature artificial intelligence (AI) and machine learning (ML). Even though...

There is much that large-scale commercial stem cell therapy processes can adopt from the existing bioprocessing industry. This article addresses some of the unique challenges posed by large-scale stem cell and stem cell...

Regulatory Trends & Quality Initiatives - Shortages of essential medicines around the world have been an ongoing concern for patients, caregivers, and regulators and have been exacerbated by the COVID-19 pandemic. Many...

Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through...

North Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort from industry, pharmaceutical professionals, and education institutions, it is synonymous with pharmaceutical and...

As the pharmaceutical industry faces ever-changing global challenges and market forces, it must review and revise product design to ensure that quality products remain available in the marketplace while moving toward...