January / February 2023

Technical

Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation.1

  • 1US Food and Drug Administration. US Code Title 21: Food...
Technical

Pandemic-related supply chain shortages have placed constraints on the supply of essential filters and chromatography resins. An agile regulatory pathway to implement alternative filters and resins into manufacturing is necessary to ensure the continued supply of approved biologics. To allow this in the US and potentially globally, the regulatory strategy proposed in this article is to provide...

InTouch

The Commissioning and Qualification (C&Q) CoP was one of the first Communities of Practices to be established at ISPE. One of its founding members, Steve Wisniewski, Principal Consultant, CAI, said the Communities of Practice was formed in 2004 to identify and promote more efficient approaches that resulted in pharmaceutical facilities being fit for their intended purpose.

InTouch

ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality Monitoring System (PPPQMS) focuses on the key aspects of maintaining and establishing an effective PPPQMS. An effective PPPQMS is crucial to establishing and maintaining a state of control. It enables continual improvement and is key to proactively identifying the need for product quality and...

InTouch

The ninth ISPE Europe Annual Conference was the first in-person conference after a break of over two years due to the pandemic. For travel-related reasons, some attendees participated remotely. With 450 participants on-site and nearly 490 total attendees, the usual atmosphere of an

Features

In this article, potential Pharma 4.0™ technological solutions that can enhance continuous process verification (CPV) 4.0 are discussed. The necessary paradigm shift will allow companies to predict deviations more accurately, perform root cause analysis (RCA), ensure data integrity and GxP compliance, and ultimately be more competitive in a highly regulated industry.

Features

ISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and framework of the first edition and updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and...

Features

Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with machine learning (ML) algorithms demonstrating advances in performance in a wide range of tasks. However, this comes with an ever-increasing complexity of the algorithms used, rendering such systems more difficult to explain.1

  • 1Samek, W., and K. R. Müller. “Towards Explainable...
Insights

When I started working in the pharmaceutical industry, I was looking for ways to grow my knowledge, my community, and my skillset. When I founded the Emerging Leaders committee within the ISPE D/A/CH (Germany, Austria, and Switzerland) Affiliate, I knew I had found that way.