E-Letters were topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (CoPs). The content for E-Letters was submitted by professionals working in the pharmaceutical industry and was a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems. E-Letters were discontinued in 2013.
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Improving Analytical Method Reliability across the Entire Product Lifecycle Using QbD
Good manufacturing practice requires suitable and valid methods of transfer verified under actual conditions of use. Recently, European Medicines Agency (EMA) voiced concern regarding the lack of an adequate method validation specifically covering technology transfer. Current approaches to analytical technology transfer represent a one-off exercise confirming the analyst, equipment, and other components can operate the method at time of transfer. This approach still leaves uncertainty to whether the method will be reliable during the QC lifecycle. Read more
Concept Paper Calls for Better QbD Knowledge Management
The Data Management Task Team of ISPE’s PAT community published the Concept Paper, “Implementing Knowledge Management in Bioprocesses: A QbD Driven Approach Turning Data into Knowledge in Reference to the CMC A-Mab Case Study.” The paper discusses information and knowledge management implementation in a QbD environment based on a CMC A-Mab Case Study. The aim of the paper is to analyze gaps in state-of-the-art QbD strategies for data and knowledge management, suggest solutions, and demonstrate potential benefits for improved quality and economy. More.
Impact of Data and Knowledge Management to a Successful QbD Implementation Based on the A-Mab Case
A presentation by Andreas Schneider, Vice President Life Science Alliances, Roche Diagnostics Switzerland, gives an overview of the PAT community’s Data Management Task Team and key aspects of the CMC A-Mab Case Study and their recently published Concept Paper, “Implementing Knowledge Management in Bioprocesses: A QbD Driven Approach Turning Data into Knowledge in Reference to the CMC A-Mab Case Study.” More.
ISPE European Conference on QbD for Generic Medicines
ISPE and the European Generic Medicines Association (EGA) will join to host the first event in Europe focusing on the practical application of Quality by Design (QbD) to the pharmaceutical development and manufacturing of generic medicines. The event, to be held 27-28 June 2012 in Brussels, Belgium, will include keynote speeches from the EMA Quality Working Party as well as experts from regulatory authorities and the generic medicines industry. The US FDA Office of Generic Drugs will be invited to share their view. Strong emphasis will be put on providing case studies. More.
Good Practice Guides Focus on Quality by Design Principles and Practices
ISPE released Parts 1 and 2 of a new series of Good Practice Guides on Product Quality Lifecycle Implementation (PQLI®). The Guides collectively address product and process development through a Quality by Design (QbD) approach that covers the entire product lifecycle. The series uses ICH guidelines Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System as a basis, together with other relevant ICH guidelines. More.
Introduction to Process Analytical Technology (PAT)
In response to COP member requests for fundamental training, an educational webinar titled “Introduction to Process Analytical Technology” was prepared by a focused task team of PAT experts in the Summer/Fall of 2009. Content was first delivered at a webinar event on 29 October, presented jointly by Line Lundsberg of NNE Pharmaplan and Joep Timmermans of Pfizer. The training material focused on the fundamental aspects and was designed primarily for practitioners new to the field, including those who may be involved in a PAT project, or may be simply interested in learning more about PAT. The training will ultimately become part of a two-part ISPE webinar series, where the second session will further explain how the PAT initiative fits within the broader concepts of Quality by Design (QbD) and Product Quality Lifecycle Implementation® (PQLI®). Read more.
New ASTM Standard Guide for Risk Assessment and Risk Control as it Impacts the Design,
Development, and Operation of PAT Processes for Pharmaceutical Manufacture
ASTM E2476 – 09, released in August 2009, is intended to provide guidance regarding the use of risk analysis in the development, day-to-day running, and continuous improvement of pharmaceutical processes incorporating PAT. According to the guide, since PAT is defined as being “risk-based,” it is important that a consistent approach to the use of risk methodologies is adopted, to ensure rapid transfer of process understanding within the development and manufacturing teams, and to the regulators where that is appropriate. Read more.
PAT Used for PQLI and QbD: Implementation Update, Examples, Discussion
There is a stated need by industry for concrete PAT/QbD examples. PQLI and PAT concepts are well defined; however, there are still more questions than answers on how to successfully implement and why the industry would want to devote resources to these concepts. The ISPE Annual Meeting 2009 included an education session devoted to the presentation of three PAT Case Studies. Pharmaceutical and Biotech implementation methods and lessons learned were discussed.
An ISPE Webinar is planned to help participants understand how to communicate the concepts to stakeholders; research and develop process data gathering projects using PAT/PQLI; determine a path forward for utilization of process data for process improvement; and understand and determine the application of process improvement tools and methods in a validated environment. Read more.
What the PAT Community is Discussing Right Now
ICH Q8 design space, NIR for final release of intact tablets, raw materials – NIR identification, and raw material identification – avoiding NIRS cross contamination, continue to be hot topics of discussion on the PAT COP site. Read more.
Australia’s TGA Publishes their Approach to Regulating PAT
The presentation provides an overview of two regulators' (US FDA and EMEA) approaches in relation to PAT in the pharmaceutical industry, the TGA's current approach, and some broad expectations for companies implementing PAT initiatives. Read more.
Real-Time Info from TOC System Improves Decision Making in Cleaning Process
An online TOC measurement system provides improved process information in real time for a cleaning process, which enhances the ability to make effective decisions regarding cross-contamination risks and product quality. Read more ( 33 KB).
PAT Questions Remain
The PAT COP Steering Committee is aware that there are still many questions regarding PAT implementation. The Steering Committee is creating a list of questions that may be used in future training sessions. Please contribute to the conversation by posting any questions that still perplex you regarding PAT implementation. Read more.