Articles should focus on the role and elements of a quality management system and its impact on the overall risk management approach, as well as its implementation in a scientific and pragmatic manner. Case studies could demonstrate the purpose, elements, and implementation of risk management and a quality management system and systems validation.

From Data to Knowledge Management: What to Consider
Features
From Data to Knowledge Management: What to Consider
Although data and knowledge are both stand-alone disciplines that need to be systematically managed, they also must have a connection. Understanding the relationship between data and knowledge management processes and how people are leveraging advances like Pharma 4.0™ combined with these processes enables quality data transition to knowledge that can help pharmaceutical companies. The authors...
Effective Knowledge Management in Mergers and Acquisitions
Features
Effective Knowledge Management in Mergers and Acquisitions
As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation and evolution is mergers and acquisitions (M&A). M&A can enable academic researchers and small companies to fund and commercialize innovative products. In addition, M&A can help larger organizations secure new and complementary technology and products. In the pharmaceutical...
Knowledge Centers Improve Knowledge Capture and Sharing
Features
Knowledge Centers Improve Knowledge Capture and Sharing
As the industry experiences significant changes to the way we do business, knowledge capture and sharing are more important now than ever before. The maturing digitalization of the biopharma industry’s business and processes is creating an increasingly data- and information-rich environment that requires more effective mechanisms for sharing data and information. The Knowledge Management team...
From Data to Knowledge Management: What to Consider
Features
From Data to Knowledge Management: What to Consider
Although data and knowledge are both stand-alone disciplines that need to be systematically managed, they also must have a connection. Understanding the relationship between data and knowledge management processes and how people are leveraging advances like Pharma 4.0™ combined with these processes enables quality data transition to knowledge that can help pharmaceutical companies. The authors...
Effective Knowledge Management in Mergers and Acquisitions
Features
Effective Knowledge Management in Mergers and Acquisitions
As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation and evolution is mergers and acquisitions (M&A). M&A can enable academic researchers and small companies to fund and commercialize innovative products. In addition, M&A can help larger organizations secure new and complementary technology and products. In the pharmaceutical...
Knowledge Centers Improve Knowledge Capture and Sharing
Features
Knowledge Centers Improve Knowledge Capture and Sharing
As the industry experiences significant changes to the way we do business, knowledge capture and sharing are more important now than ever before. The maturing digitalization of the biopharma industry’s business and processes is creating an increasingly data- and information-rich environment that requires more effective mechanisms for sharing data and information. The Knowledge Management team...
Figure 1: Thermal energy capacity: steam versus electricity.
Technical
Introduction to Steam Quality and Testing
Steam is the most powerful and effective thermal energy transfer fluid, and its use continues to grow in process industries around the world. However, there is very little written about the commissioning and qualification of pharmaceutical pure steam systems in GMP regulations or regulatory guidance. This article provides the background and science behind the steam quality tests and proposes a...
Integrating Knowledge Management and Quality Risk Management
Features
Integrating Knowledge Management and Quality Risk Management
ISPE held an Expert Xchange on 18 January 2022 entitled “Risk-Based Decision Making: Advancing the Integration of Quality Risk Management (QRM) and Knowledge Management (KM).” The session included presentations and interactive exercises that generated new and useful insights into the current effectiveness of the knowledge that flows into QRM and how a knowledge map can be used to diagnose...
Data Integrity in Regulated Environments ALCOA+ for Pharmaceutical Waters
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Data Integrity in Regulated Environments ALCOA+ for Pharmaceutical Waters
The completeness, consistency and accuracy of data is of ever-growing importance in the pharmaceutical industry. The ALCOA+ framework is designed to ensure data from equipment used in drug manufacturing is of the highest integrity. In respect to sensors for pharmaceutical pure water systems, it is important to have a tool that can help your water system be in compliance with the highest...
Article
Technical
Lessons Learned in Global CQV
Global commissioning, qualification, and validation (CQV) project delivery has in recent years been required to push the boundaries on delivery methodologies and techniques to ensure sufficient production capacity is available to meet ever-expanding patient needs. This article focuses on lessons captured in the execution and resource management of large-scale global CQV projects in an...
Figure 1: Potency assay blind control Xbar-S chart.
Technical
Risk-Based Continued Test-Method Performance Verification System
Good data are a characteristic of good science. Quality data are arguably more important today than ever before and are considered by many to be a corporate asset because they are used to develop products and processes, control our manufacturing processes, and improve products and processes when needed.1
  • 1Snee, R. D. “Crucial Considerations in Monitoring Process Performance and...
Figure 1: Example of fishbone analysis as a tool for risk identification.
Technical
Quality Risk Management to Address Product Impurities
Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts about N-nitrosodimethylamine (NDMA) impurities in drug substances such as ranitidine and metformin have demonstrated the urgent need for manufacturers and regulators to control impurities throughout the product life cycle to ensure patient safety.1
  • 1US Food and Drug Administration....
Self-Calibrating Thermometers for Use in Medical Autoclaves
Technical
Self-Calibrating Thermometers for Use in Medical Autoclaves
A temperature sensor in a medical autoclave is typically calibrated once a year. If the sensor proves to be inaccurate, all batches produced since the last calibration must be evaluated. Endress+Hauser has developed a self-calibrating sensor that automatically verifies its accuracy during each sterilization batch. This article describes a case study at the Merck Healthcare KGaA sterile...
Validation of Clinical Trial–Related Systems in Smaller Enterprises
Features
Validation of Clinical Trial–Related Systems in Smaller Enterprises
Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 51  are applicable to a variety of life sciences organizations...
  • 1International Society for Pharmaceutical Engineering. GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2008.
Figure 1: Dry block instruments for calibration to 55°C (left) and 75°C
Technical
Lyophilizer Instrumentation Calibration: Principles & Practices
Historically, the pharmaceutical industry’s focus has been on the lyophilization process and equipment, but discussion about calibration of process monitoring and control instrumentation has been quite limited. Recently, focused attention has been given to control and monitoring instrumentation for lyophilization.
Figure 1: Batch simulation using MVDA
Technical
Continued Process Verification in Stages 1–3
Continued process verification (CPV) as defined in the US FDA process validation guideline1 helps bring quality management and compliance in the pharmaceutical industry to the next level, but it has been challenging to...
  • 1US Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” 2011. https://www.fda.gov/media/71021/download
Organization demographics of survey respondents; n = 25, with 20 unique organizations
Online Exclusives
Knowledge Management Implementation: A Survey of the Biopharmaceutical Industry
Knowledge management (KM) has been a recognized discipline for over 20 years in other industries, although within the biopharmaceutical industry, its discussion and formal implementation have been slow to gain momentum. The topic gained regulatory significance in 2008 when the ICH guidance document Pharmaceutical Quality System: Q10 included knowledge management as a key enabler of a...
Wearable Devices & Biometrics Improving Efficiency in GxP Operations
Features
Wearable Devices & Biometrics Improving Efficiency in GxP Operations
As the old saying goes, “Time is money.” In today’s industrialized world, this adage is profoundly true. Manufacturers can no longer afford to overlook operational excellence. A new production philosophy called “Lean manufacturing” has been developed to save as much time as possible during manufacturing processes. In some industries, such as the automotive sector, Lean has almost been...
Figure 2: ISPE Pharma 4.0™ operating model
Features
Applying Holistic Control Strategy in Pharma 4.0™
Applying emerging technologies can lead to more robust and flexible manufacturing processes that in turn can help the pharmaceutical industry respond to drug shortages, reduce interruptions in production and delivery of medicines, ensure consistent clinical performance of products, and achieve other benefits. Although some may believe that regulators are averse to the use of emerging...
Figure 2: Steps in a holistic cleanroom concept.
Features
A Holistic Cleanroom Concept: Higher Quality & Greater Flexibility
As the pharmaceutical industry balances demands for small-batch and blockbuster products and encounters new regulations, there is a need for efficient and safe production technologies that can meet stringent quality and safety requirements for the aseptic filling of drugs. Looking forward, manufacturers should anticipate future format, packaging, and filling needs, and seek technologies with...
Article
Technical
Evaluation of Visual Inspection in Parenteral Products
According to US Pharmacopeia (USP) Chapter <790>, “all parenteral products should be essentially free from any visible particles.”1  This is the first and foremost requirement stated in all pharmacopeia for any injectable product. However, yielding absolutely particle-free...
  • 1United States Pharmacopeia. USP Chapter <790>: Visible Particulates in Injections.
Article
Technical
Inline Dilution: An Agile Capability for Downstream Manufacturing
As the global population demands faster and more affordable drugs, biopharmaceutical companies are continually trying to find ways to produce their drug products more economically and efficiently. Today, the competition and need for drugs are greater than ever before. Companies have been considering operational alternatives to reduce production costs and increase manufacturing rates.1
Article
Technical
Quality By Redesign of a Legacy Product Case Study
In recent years, the concept of quality in the pharmaceutical industry has evolved from the idea of testing the quality to designing the quality. The fundamental idea is very simple; it is necessary to understand the material and process variables that determine the final product’s quality from the beginning of product development. Such an approach permits an in-depth understanding of the...
testing
Technical
Making CPV a Proactive Component of Process & Product Improvement
Change often takes years longer in the pharmaceutical industry than in others. Why can we not challenge that paradigm? The auto industry, for example, successfully forced changes to its supplier base within a couple of years. By benchmarking other industries that have dealt with similar problems, we can learn from their experiences.