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Stay updated on latest GMP trends through our webinars and articles
Manufacturing
Qualistery

Future Ready Pharma Packaging Insights from OMAG

At CPHI Milan 2024, I had the opportunity to interview Giovanni Nocita, Sales Director of OMAG, a company with 50 years of experience in the packaging industry. OMAG specializes in creating customized packaging solutions for various sectors, especially pharmaceuticals. With a focus on efficiency, safety, and customer satisfaction, OMAG has consistently adapted to the evolving demands of the pharmaceutical landscape, offering innovative solutions that ensure compliance and enhance operational excellence.

Qualistery October 18, 2024
Mastering Root Cause Analysis A Comprehensive Guide for Quality Management in Pharma
Deviations
Qualistery

Mastering Root Cause Analysis: A Comprehensive Guide for Quality Management in Pharma

In the fast-paced world of pharmaceuticals, mastering root cause analysis (RCA) is essential for maintaining product quality and compliance. This comprehensive guide delves into the intricacies of effective investigations, highlighting the importance of identifying underlying causes to prevent future errors. With insights from industry expert Kay, a seasoned quality management consultant, you’ll discover practical tools and strategies to enhance your organization’s quality management system. Join us as we explore the critical steps of RCA, from problem definition to implementing corrective actions, and learn how fostering a culture of continuous improvement can transform your approach to quality management.

Qualistery October 17, 2024
Regulations
Qualistery

Innovating Cold Storage: Insights from FARRAR on Life Sciences and Pharmaceutical Solutions

In the fast-paced world of life sciences and pharmaceuticals, the demand for innovative cold storage solutions is rapidly increasing. At CPHI Milan, Scott Masiella from FARRAR shared insights on emerging trends such as the need for ultra-low temperature processes, sustainability efforts, and the importance of strategic partnerships. With cutting-edge technology like 4-Stair Technology, FARRAR is dedicated to redefining cold storage, ensuring high yield production while maintaining compliance with industry standards.

Qualistery October 17, 2024
Audits
Qualistery

Enhancing Supplier Qualification Practices in the Pharmaceutical Industry: Insights from PHARMALANE UK

In the competitive pharmaceutical landscape, effective supplier qualification practices are essential for ensuring quality assurance and regulatory compliance. Insights shared by Paresh Tank, Chief Quality Officer at PHARMALANE UK, during the recent CPHI Milan conference shed light on the common challenges faced by pharmaceutical companies in supplier management.

Qualistery October 16, 2024
Microbiology
Beatriz Rodriguez

The Culture of Continuous Improvement Strategy  

In a world of constant change, achieving perfection is an ideal. The focus should be on continuous improvement, optimizing processes to align with business goals. Kaizen and the PDCA cycle facilitate this by engaging everyone in the organization, minimizing variations, and ensuring resources are allocated effectively, fostering a culture of excellence.

Beatriz Rodriguez September 26, 2024
Temperature Control
Nathan Roman

Temperature Mapping: Life Sciences: Controlled Temperature Chambers, aka “Freezers, Refrigerators and Incubators”

Temperature control is vital in the Health and Life Science Industry to ensure the safety, quality, and efficacy of products. Proper equipment qualification, temperature mapping, and ongoing monitoring are essential to maintain compliance with regulatory standards, preventing temperature excursions that could compromise sensitive food and drug products.

Nathan Roman September 20, 2024
Artificial Intelligence
Wagner Moi

Regulatory Considerations for Technological Integrations (AI, Automation, Cloud Software, etc.) in GMP

Organizational leaders are keen to harness innovation in digitization and data sciences while addressing concerns about data integrity and cyber security. Compliance with GMP regulations is crucial, requiring qualified digital solutions and effective risk management. Embracing a unified platform can transform data into actionable insights, driving informed decision-making in the Digital Revolution.

Wagner Moi September 4, 2024
General
Beatriz Rodriguez

Microbiological marker: which one to use?

Microorganisms are very diverse, multiple types, exist everywhere. How do we know we are working
with the right ones for quality, predictability, efficacy testing purposes, and more? We will briefly
discuss key definitions, principles and what global standards use and recommends. Stay tuned!

Beatriz Rodriguez July 25, 2024
Medical device
Sumatha Kondabolu

Software Validation for Software as a Medical Device (SaMD): Ensuring Safety and Efficacy

Software Validation for Software as a Medical Device (SaMD) is a critical process that ensures the safety, efficacy, and regulatory compliance of software intended for medical purposes. Unlike traditional medical devices, SaMD operates independently of physical hardware, making its validation process unique and complex. This article delves into the key steps, regulatory requirements, and best practices involved in validating SaMD, providing valuable insights for developers, manufacturers, and regulatory bodies.

Sumatha Kondabolu June 28, 2024
Artificial Intelligence
Mona Ahmed Sayed

Integration of Artificial Intelligence in Pharmaceutical Manufacturing

Integration of Al in pharmaceutical manufacturing
Using artificial intelligence (AI) and machine learning (ML) are the most innovative technologies that are increased over the past few years in Pharmaceutical industry.
the integration of AI technologies holds great promise for accelerating drug development, improving patient outcomes, and revolutionizing the pharmaceutical industry

Mona Ahmed Sayed June 24, 2024

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