Quality Systems

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.

A Strategy for the Analysis of Dissolution Profiles - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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...
A Strategy for the Analysis of Dissolution Profiles - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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 - ISPE Pharmaceutical Engineering
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.