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.

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...
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...
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...
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...
Data Integrity in Regulated Environments ALCOA+ for Pharmaceutical Waters
Sponsored Content
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...
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...
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...
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...
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...
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® 5International Society for Pharmaceutical Engineering. GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. North Bethesda, MD: International Society for Pharmaceutical...
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...
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 guidelineUS Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” 2011. https://www.fda.gov/media/71021/download helps bring quality management and compliance in...
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...
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...
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...
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,...
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.”United States Pharmacopeia. USP Chapter <790>: Visible Particulates in Injections. This is the first and foremost requirement stated in all pharmacopeia for...
A Strategy for the Analysis of Dissolution Profiles
Technical
A Strategy for the Analysis of Dissolution Profiles
In this article, a new method for the analysis and comparison of dissolution profiles is proposed and illustrated with case studies. This useful strategy makes effective use of dissolution profile data by using all data in each profile to create two...
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...
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...
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,...
Special Report Quality Metric
Special Reports
Special Report Quality Metrics
ISPE Proposes an Advancing Pharmaceutical Quality Program The ISPE Quality Metrics team has proposed an industry-led approach to advance pharmaceutical quality beyond the submission of data for three harmonized, reportable metrics: the Advancing...
Article
Technical
Process & Product Contact Surfaces in Bioprocessing
As part of their quality risk management (QRM) programs, many biopharmaceutical manufacturers have made deliberate efforts to classify systems, equipment, and components by their potential to affect product quality. In assessing these risks, it is...
Article
Technical
History of Quality & the Evolution of the Modern Leader
The Food and Drug Administration (FDA) report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach”14 was an introduction to quality by design (QbD), the concept that quality should be built into a product. According to the FDA report...
Article
Technical
Quality Risk Management for Legacy Products in CMOs
This article was published in the March/April 2016 edition of Pharmaceutical Engineering® magazine. It is one of five articles nominated for the Roger F. Sherwood Article of the Year Award, all which will be posted to iSpeak throughout the week of 5 December.