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.

Technical
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...
Technical
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...
Online Exclusives
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...
Features
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...
Technical
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...
Technical
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...
Online Exclusives
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...
Features
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...
Features
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...
Features
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,...
Technical
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...
Technical
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...
Technical
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...
Technical
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...
Technical
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 Reports
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...
Technical
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...
Technical
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...
Technical
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.